ABSTRACT
The purpose of this study is to evaluate the effectiveness of an efficacy-enhancing treatment modality and compare it to standard of care in the treatment of depression in breast cancer patient specifically focusing on time of diagnosis, end of treatment and at time of recurrence.
Women with breast cancer will suffer from depression and will often benefit from some extra emotional support. Shock, anxiety, sadness and depression are natural reactions to breast cancer. Even if there is a supportive network of family and friends, a need to discuss these feelings will arise. Counseling can be particularly helpful when breast cancer can disrupt relationships, sex life, or plans for childbearing. If patients are experiencing depression, they may improve more rapidly with the help of brief counseling and or an efficacy-enhancing modality given at the above intervals. This should improve patient recovery both emotionally and with the cancer itself as we will see later.
Depressive symptoms range from mild to severe, from normal states of sadness to clinical syndromes, such as an adjustment disorder with depressed mood or a major depression (Brandt 2002). While the psychological phenomenon is certainly not unique to women with breast cancer, this program will examine depression in the context of breast cancer. This research will help to determine the impact of early interventions at the time of diagnosis, at time of recurrence and at end of treatment care to help decrease the impact of depression and enhance survival and quality of life of women diagnosed with breast cancer
Review of Literature
Depression is a serious medical condition that affects thought, feelings, and ability to function in everyday life. Depression can occur at any age. National Institute of Mental Health-sponsored studies estimate that 6% of 9 to 17 year olds in the U.S. and almost 10% of American adults, or about 19 million people age 18 and older, experience some form of depression every year (Shaffer,1996). Although available therapies alleviate symptoms in over 80 % of those treated, less than half of people with depression get the help they need (National Advisory, 1993).
Several types of abnormal depressed mood have been documented in individuals with cancer. These diagnoses are based on specific criteria outlined in the Diagnostic and Statistical Manual of Mental disorders (American Psychiatric Association, 1994). The most common psychiatric diagnosis in cancer patients is adjustment disorder with depressed mood. This diagnosis is used to characterize depressive symptoms in response to identifiable stresses such as with cancer. Another psychiatric diagnosis of depression that has been observed in cancer patients is a major depressive episode (American Psychiatric Association, 1994). The essential feature of this disorder is a period of at least two weeks during which there is either depressed mood or loss of interest in nearly all activities. Additional symptoms must also be present to make this diagnosis, these include feelings of worthlessness or guilt, diminished ability to concentrate, recurrent thoughts of death, weight gain or weight loss, insomnia or hypersomnia, psychomotor agitation or retardation or fatigue.
The prevalence of clinically significant depression in women with breast cancer or its relationship to illness related factors is diminutive. In a study of 359 women with early stage breast cancer, depression was observed in 6% of those participants 1 to 3 months after diagnosis (Watson,1991) Another study found that out of 205 women interviewed 18 months after first diagnosed with breast cancer, 44 women had symptoms of major depression in the preceding weeks (21%) (Mausell, 1992). In a sample of 22 women with local recurrence, ten women experienced anxiety and depression (45%). With advanced breast cancer, anxiety and depression are common symptoms as reported in one series of 35 of 139 women (25%) in one series (Pinder, 1993) and 20 of 81 women (25%) in another study (Hopwood, 1991) Anxiety and depression was reported in up to 25 % of women with advanced breast cancer: on third of the cases may be persistent (Pinder, 1993).
One of the unique features of breast cancer is its relationship to the precipitating factors for the disease. What is it specifically about a diagnosis of breast cancer that places a woman at risk for depression? Gaining insight into potential mechanisms that can contribute to enhancing quality of life by decreasing the affects of depression on breast cancer survivors would provide for the adoption of cost effective psychosocial interventions that may improve the survivorship and treatment adherence. Physical and psychological impacts made by a diagnosis of breast cancer are immense (Taylor, 1989). Depression is a comorbid disabling syndrome that can affect 15 % to 25 % of cancer patients (Degrogatis, Morrow, 1983). When a woman is diagnosed with breast cancer and hears those words associated with her body it brings with it a whole range of strong emotions. Researchers have found that women with breast cancer have an increased incidence of depression and anxiety than women without the disease (Feting, 1997).
It is estimated that 20%-25% of patients diagnosed with breast cancer would meet the criteria for clinical depression. There are several risk factors implicated in cancer-related depression, including: receiving a life– threatening diagnosis, receiving intravenous chemotherapy, middle and end phase of treatment, risk of recurrence and treatment induced menopause (Rennie, 2000). Any phase of treatment may bring about depression. Two known high-risk phases for emotional distress are in the middle of treatment when patient may experience unpleasant side-affects, such as nausea and hair-loss and at the end of treatment, when supportive care with health professionals are less and active treatment is completed. Beyond these psychological factors that may play a role in depression there are also the physiological factors, such as the role of estrogen and possible peri- menopause or menopause during active treatment with chemotherapy. In one study of more than 1500 women, those with surgical menopause were twice more likely to be depressed than those women with naturally occurring menopause (McKinlay, 1987). Because of these additional psychological and physiological factors some women with breast cancer will have a greater propensity to experience depression. Understandably, a woman who under goes mastectomies may experience a negative reaction to body image change that occurs with the loss of a breast. Patients may also experience a diminished sense of femininity and changes in sexual function, all of which may trigger depression.
Causes of depression are continually being reviewed. An interaction between genetic predisposition and life history appears to determine a person’s risk. Episodes of depression may then be trigged by stress, difficult life events, side-effects of medications or other environmental factors. Whatever the origins it is important to recognize the disorder to limit its affect on overall health affects and help to preserve energy to keep focused on treatment for other disorders such as cancer.
Coping styles have been identified as mediating psychological adjustment to breast caner and affecting subsequent morbidity and mortality (Dunkel-Schetter, 1992) Women with an active style of coping had significantly higher recurrent- free survival rates after 5 and 10 years than those with stoic acceptance and helplessness/hopelessness (Pettingale et al, 1985) Similarly, melanoma survivors exhibiting self-effacing and nonassertive personality styles had thicker tumors than patients with a more active , impatient and controlling personality style (Temoshok, 1985) Short-term survival status has been predicted by certain affective variables such as self-esteem and a positive attitude, even after the study control treatment related variables and controlled for type of cancer (Stein, Linn and Stein, 1989). Thus it appears that patients with assertive, positive and take- charge personalities live longer and have less disease regression than individuals using helplessness or self-effacing coping styles. The assertive, in charge type of coping styles reflects a high coping self-efficacy or a patient’s belief that she will be able to manage the challenges inherent in coping with a cancer diagnosis and treatment
The Social Cognitive Theory (Bandura, 1986), states that human behavior results from the interaction of multiple factors: personal, environmental, and behavioral. Personal factors reside within an individual and include psychological constructs such as self-efficacy and self-regulation and biological features such as eye color or height. Self-efficacy is the beliefs that regulate human functioning through cognitive, motivational, affective and decisional processes. They affect whether individuals think in self-enhancing or self-debilitating ways; how well they motivate themselves and persevere in the face of difficulties: the quality of their emotional life, and the choices they make at important decisional points which set the course of life paths. Self-regulation refers to the process of planning, monitoring and changing one’s behaviors and cognitions to correspond with one’s abilities, environment and desired outcomes (Bandura, 1997). For the women with breast caner, efficiency-enhancing techniques help with setting attainable and incrementally more challenging goals for overall coping and functioning.
Self-efficacy (Bandura, 1986) has been shown to impact on health practices as well as adaptation to illness and treatment. Increased self-efficacy is associated with increased adherence to treatment, increased self-behaviors and deceased physical and psychological symptoms (Lev, 1997).
Self-efficacy, or “beliefs in one\'s capabilities to organize and execute the course of action required to produce given attainments (Bandura, 1997) plays a critical role in quality of life and adjustment for cancer patients. Intervention to improve quality of life by decreasing depression in cancer survivors has incorporated information for coping with the disease and assessing affective reactions. One’s belief in coping abilities has been shown to predict a more adaptive psychological and physiological functioning (Bandura, 1997), which in turn would indicate a better outcome in dealing with depression. A person’s response to the multiple resources of their life may be influenced by self-efficacy, as that is what shapes an individual’s behavior and attitudes, especially in relation to one’s outcome expectation. However, personal factors are not the only consideration. Environmental factors also influence the final decision. Influences from outside sources such as, family, friends and health care professionals may also indicate or influence opinion about cancer and cancer treatment and the success of their response to treatment despite obvious negative feedback or positive feedback. Numerous large scale meta analyses have been conducted on findings from studies with diverse experimental and analytic methodologies applied across a diverse sphere of functioning. The converging evidence from these diverse lines of research verifies efficacy beliefs contribute significantly to the quality of human functioning. The continuing question of free will versus determinism is evident here. Most people gravitate towards free will efficacy (Bandura, 1997)
The term used for the above sets of factors which influence and act upon one another is known as reciprocal determinism (Bandura, 1986). Reciprocal determination is the belief that the environment does not only influence the person—the person also influences the environment. An example of this is a personal factor such as self-efficiency. Among the mechanisms of human behavior none is more central or pervasive than the beliefs of personal efficacy (Bandura, 1997). Whatever other factors serve as guides and motivators, they are rooted in the core belief that one has the power to produce desired effects by one’s actions; otherwise one has little incentive to act or to persevere in the face of difficulty, such as when faced with the diagnosis of breast cancer.
Using the lens from Social Cognitive Theory women with breast cancer may experience fear of abandonment, as well as a sense of isolation due to real or perceived social stigmatization. Some friendships may strengthen while other will falter because friends do not know what to say or do to support the patient, causing them to withdraw. Disease and treatment may at times necessitate role reversal, creating guilt, anger and despair in the women, her partner and her children. The financial burden of the illness may threaten life goals and commitments and outcome expectations. Normal body image changes associated with normal aging maybe exacerbated by the therapy, such as alopecia, fatigue, nausea vomiting, weight gain and menopausal symptoms.
Treatment for depression can help people feel and cope better with their cancer treatment process. There is evidence that the lifting of a depressed mood can help enhance survival (Ries, 2000). Efficacy-enhancing techniques, as well as medication can contribute. Although significant psychological distress exists in women with early stage breast cancer patients may be reluctant to openly discuss their concern and distress to their doctor and in the constraints of a busy clinic schedule, oncology staff members may not have the time to ask (Maraste, DeFlorio, 1995).
Certain crisis or transition points in breast cancer disease trajectory may influence the degree of psychosocial morbidity. For some women, anxiety and depression may be more prevalent at the time of diagnosis, and at the beginning and end of primary therapy. Anticipation of chemotherapy may serve to produce fears of potential side effects with reactive anxiety and depression. Fears of recurrence may peak at the completion of adjuvant chemotherapy or radiation, possible precipitating anxiety and depression (Rowland, 1990). Critical events such as recurrence or treatment failure may be more traumatic than the initial diagnosis, because the prognosis is perceived as grave. With recurrence, many of the fears experienced at the time of initial diagnosis may resurface.
There is evidence that clinicians underrate symptoms of major depression in patients with cancer. A number of factors in today’s modern health care delivery systems may increase the likelihood of overlooking the diagnosis of clinical depression in women with breast cancer. Some of these factors may be related to limited patient-doctor contact, side-effects of chemotherapy occurring simultaneously with the on-set of depression, lack of training to identify symptoms of depression in medical staff and patients’ avoidance of health care professionals. The prevalence of early discharge after surgical treatment for breast cancer as well as outpatient chemotherapy provides little time for patient-caregiver interactions. Results of biopsy or staging work-up may not occur for several hours to several weeks, leaving the patient with a void and lack of support at a time which could be critical in decreasing her level of anxiety and later depression. In one study, women who were depressed were less likely to accept chemotherapy than women who were not depressed ( Colleoni, 2000).
The aim of this study is to explore an efficacy-enhancing program on women with breast cancer, specifically at time of diagnosis, at completion of chemotherapy and time of recurrence and evaluate the effectiveness of these interventions as they relate to depression. This paper will also examine the best time to use treatment interventions and at what time intervals these treatment options would optimize the patients need for depression intervention and to provide for a better quality of life.
METHODOLOGY
SAMPLING
The study group will come from LAC/USC Medical Center and the Norris Cancer Hospital. These combined hospitals see over 226 patients a year diagnosed with breast cancer. Women will be recruited to the study from the data base, at both hospitals, of women The purpose of this study is to evaluate the effectiveness of an efficacy-enhancing treatment modality and compare it to standard of care in the treatment of depression in breast cancer patient specifically focusing on time of diagnosis, end of treatment and at time of recurrence. Women will be recruited to the study using the data base from both hospitals of newly diagnosed breast cancer (simple random sampling technique). Newly diagnosed women will be approached by the Research Nurse Coordinator or the treating physician and asked to participate in the study. At this time both the research nurse and the Physician will go over the informed consent to explain the research project. The patient will be asked to take the inform consent home to read and return as per scheduled with MD visit or call nurse with decision. If the patient agrees they will then be randomly assigned, using a computer program, to the treatment arm. This technique is based on probability sampling technique and can be generalized to this sampling frame. In probability sampling, the sample is selected in such a way that each unit within the population has a chance of being selected. It is a concept that allows for statistical projection of characteristics based on the sample to the population. The potential problems with this form of sampling are related to the disparity of a population, as it may be too costly to reach the whole population. Another problem that can arise is related to weighting the sample to reflect the population, but because we are looking at a homogenous group this problem can be overcome.
RESEARCH DESIGN
The project was designed as a two-group randomized treatment design with attention toward a balance in treatment.
R O X1 O O
R O X2 O O
These design utilities a control group, including random assignment, to equalize the comparison groups eliminate threats to internal validity. Looking closer to each internal threat, history, which is related to a historical change that can affect or change the attitude of study population, can be ruled out because each group will be exposed equally to any type of historical event that might attribute to changes in the variables. In relation to maturation, which is the nature passage of time, the same amount of time passes for each group and the population will be randomly assigned, therefore maturation can safely be ruled out. Instrumentation effect can be controlled with this design because any unreliability can be ruled out by means of the comparison group. Random assignment controls for regression to the means which is related to extremes in conditions, as with depression. You can have extremely depressed women and some just slightly depressed, because this study will be randomly assigned this is not a threat to internal validity. Randomization controls for selection. Selection bias can rule out internal validity because of randomization. Testing in this study will have a role as all groups will be tested and become familiar with the test but because they are randomly assigned and everyone will be participating with the same test it should limit the threat in internal validity. Selection is not a threat because of random assignment .With regards to attrition, these two groups are similar and therefore should have the similar attrition rates. The length of the study and the graveness of the disease will have affect on attrition but because of the randomization the numbers should be the same in each group and therefore should have little affect on attrition.
Using this design should provide adequate information, trends and strategies regarding the use of efficacy-enhancing techniques in providing or preventing depression in breast cancer patients. The comparison group will indicate a response to the new techniques or will provide information on this relatively new technique that may lead to valuable health promotion in this group of women.
If a breast cancer patient expresses interest in the program, the research nurse coordinator would be contacted to meet with the patient, provide more information and answer any questions or concerns the patient may have. If she chooses to participate, the Principle Investigator and the Nurse Coordinator would review the informed consent (Appendix A) and describe the process of randomization (flip of a coin). After the initial interview the study coordinator would explain the content of the efficacy-enhancing techniques if assigned to that arm. Women who agree to participate in the study would be randomly assigned to either standard of care only or standard of care plus efficacy-enhancing techniques. Informed consents will be available in English and Spanish, any other language will need the use of interpreter. All ethnicities are included and each individual has an equal chance of being in either treatment arm. All study information will be kept confidential as per Investigation Research Board (IRB) regulations.
MEASUREMENTS AND DATA COLLECTION
Types of treatment, Standard of Care plus Efficacy-enhancing techniques vs. Standard of Care alone, are the values of the independent variables for this study. A nominal definition of treatment is the application of remedies with the object of effecting or alleviating distressing symptoms. Operational definition of treatment is related to treating newly diagnosed breast cancer women for depression. One group will be randomized to Standard of care only and the other group will be given additional support with the use of efficacy-enhancing material (Appendix F). Both groups will be referred to a License Clinical Social Worker ( LSCW) for individualized counseling for depressive symptoms for long term treatment. The LSCW will work in conjunction with the treating Oncologist and a Psychologist for any medication issues. Both groups will have a weekly counseling session for the duration of patient treatment (approximately 1 year). The randomized group will have in addition to their individual counseling session an additional session to learn the efficacy enhancing techniques, which will be bimonthly. These techniques will be explain and taught by the research nurse coordinator with the assistant of a Facilitator and a Tibetan taught yoga instructor. Yoga is an ancient Eastern tradition that usually includes regulated breathing, moving through various postures and mediation; also know as mind-body techniques (Gelb, 2004). Because the movements are gentle and simple with emphasis on controlled breathing, visualization and mindfulness techniques, it is believed this form of yoga may be particular useful for patients undergoing and recovering from chemotherapy (Cohen, 2004). The randomized group members will be taught skills to enhance their self-efficacy by modeling and encourage positive coping strategies by the facilitator. The facilitator and the research coordinator will help women recognize the self-regulative process and practice of specific skills taught during each session. Monthly goals will be established in accordance with the topic being discussed. Throughout the program, feedback will be provided regarding participants attempts toward reaching their goals. Behaviors that bring each participant closer to her proximal goal will be discussed and encouraged. Sessions will include information tailored toward each individual group participant. Each session will focus on a topic specific to efficacy-enhancing and coping with breast cancer (Appendix F). Women assigned to the efficacy-enhancing intervention will attend the program in small group (five to eight). Recruitment will continue until accrual goal is reached at which time recruitment will close and data analyzes will began until completion of study. To evaluate overall treatment effectiveness these women will be asked to complete a health and daily living form (Appendix C) a General Self-Efficacy form (Appendix B) and the Hospital Anxiety and Depression scale ( Appendix D) at time of diagnosis, at time of enrollment, at completion of treatment with chemotherapy, surgery or radiation, and at time of recurrence. They will also be asked to fill out some general demographic information at initiation of study, to assist us in planning future programs for women with breast cancer. (Appendix E). At completion of program follow-up surveys will be mailed out to help improve our program (Appendix G).
The Health and Daily Living form (HDL) is used to examine the influence of extra-treatment factors on outcome as well as to explore the social resources and coping processes people use to prevent and adapt to stressful life circumstances. Results from the Adult form yield score index of individual functioning, stressful life circumstances, and social network resources and help seeking. Thirteen scores are related to health-related functioning, the first eight related to self-confidence and symptoms and the last 5 related to substance use and problems. In reviewing the literature reliability values are generally acceptable to high. The internal consistencies measured by Cronbach’s alpha are ranging from .77 to .92, which is considered reliable. (American Psychiatric Association, 2000).
Face and content validity where built in to the Health and Daily Living scale. Construct, discriminative and criterion-related validity were reported to be generally good. The major strength of the HDL is its attempt to standardize a questionnaire that accesses an often neglected and important feature of diagnosis and treatment. The HDL has been used in several research studies resulting in a rich body of literature regarding its value, an attempt to find data related to validity was limited. No validity data was presented in the manual (American Psychiatric Association, 2000).
Depression is one of the dependent variables and will be measured with the use of the Hospital and Anxiety Scale. Depression results from abnormal functioning of the brain. The causes of depression are currently a matter of intense research. An interaction between genetic predisposition and life history appear to determine a person\'s level of risk. Episodes of depression may then be triggered by stress, difficult life events, side-effects of medications or other environmental factors (Zigmond,1983). Whatever its origin, depression can limit activities of daily living and the coping ability needed to focus on healing.
The Hospital and Anxiety Depression Scale was developed by Zigmond and Snaith in 1983 to identify categorical (possible and probable) of anxiety disorders and depression among patients in non-psychiatric hospital clinics. It was divided into an Anxiety sub-scale (HAD-A) and a Depression sub-scale (HADS-D) both containing seven intermingled items. To prevent interference from somatic disorders on the scores, all symptoms of anxiety or depression related to physical disorders, such as dizziness, headaches, insomnia and fatigue were excluded. Most factors analyses demonstrated a two-factor solution in good accordance with the HADS sub-scales for Anxiety (HADS-A) and Depression (HADS-D), respectively, The correlations between the two sub-scales varied from .40 to .74 (mean .56). Cronbach\'s alpha for HADS-A varied from .68-.98 (mean .83) and for HADS-D from .67 to .90 (mean .82) (Bjelland, 2002). In most studies an optimal balance between sensitivity and specificity was achieved when caseness was defined by a score of 8 or above on both the HADS-A and the HAD-D. Based on these values the HAD-A and the HAD-D are both reliable and valid. It was concluded that HADS was found to perform well in assessing the symptoms severity and caseness of anxiety disorders and depression in both somatic and psychiatric and primary care patients in the general population. Based on approximately 200 papers on HADS in approximately 35,000 individuals in various patient populations it was concluded that HADS is a reliable and valid instrument for assessing anxiety and depression in medical patients (Herrmann, 1996)
The dependent variable, Efficacy- Enhancing techniques are that which help to promote personal well being and enhances human accomplishment (Bandura, 1997). Operational description: the construct of perceived self-efficacy reflects an optimistic self-belief (Schwarzer, 1992). This is the belief that one can perform a novel or difficult task or cope with adversity--in various domains of human functioning. Perceived self-efficacy facilitates goal-setting, effort investment, persistence in face of barriers and recovery from set backs. It can be regarded as a positive resistance resource factor. The measurement used to evaluate self-efficacy will be the General Self-efficacy scale. The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Reliability, in samples from 23 nations, Cronbach\'s alphas ranged from .76 to .90, with the majority in the high .80s which qualifies it as a reliable measurement. The scale is unidimensional (Schawarzer, 1992). Criterion-related validity is documented in numerous correlation studies where positive coefficients were found with favorable emotions, dispositional optimism, and work satisfaction. Negative coefficients were found with depression, anxiety, stress, burnout and health complaints. In studies with cardiac patients, their recovery over a half-year period could be predicted by pre-surgery self-efficacy (Schawarzer, 1992).
The measurement models have been used throughout the world and in many different languages; the General Self-Efficacy scale has been adapted to 26 languages and designed for the general adult population, including adolescents. This scale should not be used on persons below the age of 12 (Schwazrer, 2000). With regards to the HADS scale it has been used extensively across the nation with the ability to retain reliability and validity it has been translated into 15 other languages, it screens well for the separate dimensions of anxiety and depression when applied to samples from the general population, general practice and psychiatric patients (Bjelland, 2002).
STATISTICAL ANALYSIS
This study will analyze the effectiveness of an efficacy-enhancing treatment modality and compare it to standard of care, for the treatment of depression in breast cancer patient at time focused intervals. Information related to women’s martial status, educational status and income will be obtained with paper and pencil instruments developed by investigator (see Appendix E)
Some information (age, time of diagnosis, stage of disease) will be obtained at time of diagnosis during the initial individual interview prior to randomization to the treatment assignment to allow for balance between the intervention group and standard of care.
The dependent variable, of treatment, with the values being treatment types, standard of care and standard of care plus efficacy enhancing treatment, makes the level of measurement a nominal dichotomy. A nominal dichotomy is data that is based on categories that have no numerical value and only principle can apply to these variables.
Also dependent variables are depression and efficacy-enhancing techniques which will be measured on an interval level. They are both measured by the use of scales which will provide a mathematical numerical level for analyze. Depression will be measured using two different measurement scales. One will be the Health and Daily Living Scale and the other the Hospital and Anxiety Depression Scale. The measurement of the efficacy-enhancing techniques will be evaluated by the General Self-Efficacy scale. Lastly the independent variable of “ time” will use a nominal categorical level of measurement. The study will focus on time of diagnosis, the completion of therapy and time of recurrence, using time of diagnosis as a baseline and the post-test will at completion of therapy. The level of measurement is a nominal categorical, because time has no mathematical value.
The data collected can be summarized into a table to evaluate the effectiveness of the efficacy-enhancing technique as it related to depression. The table should show a significant decease in depression in the efficacy-enhancing group when compared to the standard of care alone group.
The study will be evaluating two independent groups. The first question for statistical analysis will be the rate of depression. Using the t-test for independent sampling to evaluate rate of depression is significantly lower when comparing the two groups. The hypothesis below will be using “u” because of the interval measurement. The interval measurement will be derived from the Health and Daily Living Scale and the Health and Depression Scale. These two scales will be analyzed separately to find the significance of their values using the t-test for independent samples.
The t-test assesses whether the mean of the groups are statistically different from each other. This analysis is appropriate whenever you want to compare the means of the two groups and is especially appropriate as the analysis for a post-test evaluation two group randomized design, such as this study.
The formula for the t-test is a ratio. The top part of the ratio is just the difference between the two means or averages. The bottom part is a measure of the variability or dispersion of the scores. When we are looking at the differences between scores for two-groups, we have to judge the difference between their mean relative to the spread of their scores. The t-test will do just this.
H 0 : u (new tx group) = u (standard of care group)
HA : u (new tx group) < U (standard of care group)
The hypothesis is stated that there will be a significant decrease in depression with the group using the efficacy-enhancing technique when compared to the standard of care group within the population. Also based on the p values , if p > .05 you would fail to reject the null hypothesis. If p value is <_ .05 we can reject the null hypothesis, which is an objective of this study.
When looking at the question related to efficacy-enhancing treatment the null hypothesis is as followed:
H 0 : u (new tx group) = u (standard of care group)
HA : u (new tx group) < U (standard of care group )
The last variable will be related to time which will be looking at the time of occurrence related to depression and time of diagnosis. Women who are newly diagnosis are more likely to have decease in depression or resolution of their depression using the efficacy enhancing group when compared to the standard of care group.
The null hypothesis will be:
H 0: There is no difference in the population between the new treatment group and the standard of care group on the level of depression.
HA: The new study group will have a lower risk of depression than the control group within the population.
The level of measurement is one dichotomy and one categorical variable and are independent samples. The test to use for statistical evaluation is the chi squared. Chi squared is a non-parametric test of statistical significance for bivariate tabular analysis. Any appropriately performed test of statistical significance lets you know the degree of confidence you can have in accepting or rejecting the hypothesis. Typically, the hypothesis tested with Chi squared is to evaluate whether or not two these two different samples are different enough in some characteristic or some aspect of behavior that we can generalize from our samples that the population from which our samples are drawn are also different in the behavior or characteristics.
A non-parametric test like chi-square is a rough estimate of confidence; it accepts weaker, less accurate data as input than the para-metric test, unlike the t-test above, and therefore has less status in the pantheon of statistical tests. None the less, its limitations are also its strengths because a chi square test is generally more forgiving in the data it will accept.
Statistical analyses will be conducted to determine if participates randomized to each group will be different at baseline, as well as to examine effects on the outcome measure.
Critique of Proposal
This study has a small sample size, which limits generalizing the results to a larger population. This sample of breast cancer patients can not be considered representative of all people who attend support groups. The findings in this study might be able to explain by variance between the types of treatments between the two groups.
The findings from this study may be in line with other studies which show that factors related to the patient rather than the disease or treatment may increase the risk of clinically important depression in women who are diagnosed with breast cancer. These risk factors include the main ones for depression in the general female population (Harrison, 2003) namely, younger age, previous psychological problems, non-cancer related difficulties and lack of social support. The quality of social support may predict a better health related quality of life. Effectiveness of dissemination of information and the communication style of those involved in treatment care may also play a role in protecting women against depression.
Another critique of the proposal may be related to the area of managed care. The necessity and feasibility of psychiatric intervention are under increasing scrutiny. To document the need for and the utility of these services, screening instruments should provide a method of effectively evaluating a large number of patients and identifying those whose psychiatric difficulty may result in better utilization of health care resources. This proposal will explore the utility of three screening measures that differed in complexity and in time demands for the patient and for staff members. We can use these instruments to educate our oncology staff about the level of psychiatric distress in their patients, to provide our colleagues with a method for evaluating patient’s distress and to provide a checkpoint on the medical oncology staff member’s abilities to identify the patients most in need of psychiatric interventions.
Concerns with quality of life in women with breast cancer supports the need to identify women at high-risk for psychosocial morbidity. Depression and anxiety, which this study does not address, are a common sequel of the diagnosis and treatment of breast cancer and may occur at varying stages of the illness trajectory. The diagnosis of depression may be overlooked unless clinical indicators for women at high risk are integrated into a systemic assessment. Consideration should be given to incorporating assessment of these factors that appear predictive of depression into the evaluation of women newly diagnosed with breast cancer. Currently the constraints on resources are a limitation of the utilization of services. The current health care environment does not support the prioritization of psychosocial services, this may be a potential problem with standardizing the care of depression in women newly diagnosed with breast cancer.
Conclusions and suggestions for future research
Research has indicated that patients with cancer are at higher risk for developing depression. (Aasa, 1997). This should be considered during initial and subsequent nursing assessments. Traditional support groups can help people with cancer function more effectively with their disease. Nurses and social workers should consider recommendations of self-efficacy methods to help people cope with their illness because they have been shown to decrease depression and foster coping in patients with cancer. Although the efficacy-enhancing groups may offer many benefits, the health care profession should be aware of the potential pitfalls and monitor their patients’ responses accordingly. Interventions to promote self-efficacy may increase quality of life and decrease distress for women diagnosed with breast cancer.
In preparation for the increased integration among psychiatry, oncology, social work and managed care, we need to reacquaint ourselves with the research demonstrating that short-term, focused interventions leading to reduced health care costs when compared with the more traditional forms of psychiatric service delivery. Consequently, we are developing a cognitive-behavioral group intervention focused on techniques for coping with breast cancer. The use of the HADS allows us to select appropriate patients and monitor the efficacy of the intervention.
The reorganization of the health care delivery systems require reexamination of treatments such as psychiatric interventions. This reevaluation may provide a new opportunity for LCSW with aid of the psychiatric consultation, screening and treatment. The use and integration of psychiatric scales in patient evaluation and diagnoses is one step closer to achieving this goal.
With one in ten women being diagnosed with breast cancer at some point in their lives, and over half of these women developing serious psychological consequences of the disease, the health care community have a clear imperative to determine the most effective treatment strategies for women with breast cancer and to make these services accessible. Proactive approach to addressing the needs of women with breast cancer has been a long time in coming, and may prove to be one of the more important advances in cancer treatment of the twenty-first century!
REFERENCES
American Psychiatric Association. (2000). Diagnostic and Statistical Manual of Mental Disorders;DSM-IV-TR. Washington, DC: American Psychiatric Association.
Aasa, N, Fossa, S, Dahl, A ., Moe TJ. (1997) Prevalence of anxiety a depression in cancer patients seen at the Norwigian Radium Hopsital. European Journal in Cancer, 33, 1597-1604.
Bandura, A (1997). Self-Efficacy: The exercise of control. New York: W.H. Freeman
Bandura, A (1986). Social Foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice -Hall.
Bandura, A (1997). Self-efficacy: The exercise of control. New York: W.H. Freeman.
Brandt P, Weinert C (1981) The PRQ: A social support measure. Nursing Research 30:227-280.
Bjelland, I (2002). The validity of the Hospital Anxiety and Depression Scale. Journal of Psychosomatic research (52) 2 pp 69-77.
Cohen S, (1988). Psychosocial models of the role of social support in the etiology of physical disease. Health Psychology, 7 (3), 269-297.
Colleoni, M., Mandala, M., Peruzzotti, G, et al (2000). Depression and the degree of acceptance of adjuvant cytotoxic drugs. 11 356, 1326-1327.
Derogatis LR, Morrow GR, Fetting J, et al (1983). The prevalence of psychiatric disorders among cancer patients. JAMA 249 (6): 751-757, 1983.
DeFlorio M, Massie MJ (1995). Review of depression in cancer: gender differences. Depression ( 3),66-80 .
Dunkel-Schetter C, Feinstein L, Taylor S, Falke R, (1992). Patterns of coping with cancer. Health Psychology, 11, 79-87.
Feting DL (1997). Depression in patients with breast cancer: prevalence, diagnosis, and treatment. Breast Journal (3) 292-302.
Green, BL, Krupnick JL, Rowland JH, et al (2000). Trauma history as a predictor of Psychological symptoms in women with breast cancer. J Clin Oncology 18 (5):1084-93.
Gelb,B (2004) Tibetan yoga helps cancer and insomnia. Medical News .
Herrmann, C (1997). International experiences with the Hospital Anxiety and Depression Scale- a review of validation data and clinical results. J Psychosom Res 42, pp17-41.
Hopwood P, Howell A, Maguire P, (1991). Screening for psychiatric morbidity in patients with advanced breast cancer: Validation of two-self-report questionnaires. British Journal of Cancer (64) 353-356.
Lev E, Owen, S (2000) Counseling women with breast cancer using principles developed by Albert Bandura. Perspectives in Psychiatric Care, 36, 131-138
Maraste R, Brandt L, Olsson H, et al (1992). Anxiety and depression in breast cancer patients at start of adjuvant radiotherapy. ACTA Oncology (31) 641-643.
Maunsell E., and Brisson, J. (1992). Psychological distress after initial treatment of breast cancer. Cancer (70) 120-125.
McKinlay JB, Mc Kinlay SM, Brambilla D. The relative contributions of endocrine changes and social circumstances to depression in mid-aged women. Journal of Health and Social Behavior 1987; (28) 345-363.
National Advisory Mental Health Council. Health care reform for Americans with severe mental illnesses. American Journal of Psychiatry, 1993; 150 (10):85-94.
Pinder KL., Rameriez AJ., Black ME., et al (1993) Psychiatric disorders in patients with advanced breast cancer: Prevalence and associated factors. European Journal of Cancer, 29A (4) 524-527.
Ries LAG, Esiner MP, Kosary CL, et al(2000). SEER Cancer Statistics Review, 1973-1997. Bethesda, MD: National Cancer Institute, NIH Pub No 00-2789.
Rennie H (2000). Breast cancer and depression: Risk factors and treatment options, Abreast in the West (1) 3.
Rowland, JH, Massie, MJ. (1998). Breast Cancer in Psycho-Oncology. Holland J, ed. New York: Oxford University Press.
Schwarzer, R(1992). Self-efficacy in the adoption and maintenance of health behaviors: Theoretical approaches and a new model. In Schwarzaer, R (Ed.), Self-efficacy: Thought control of action (pp.217-243. Washington, DC: Hemisphere
Shaffer D, Fisher P, Dulcan MK, et al (1996). The NIMH Diagnostic Interview Schedule for Children, Version 2.3 (DISC-2.3): description, acceptability, prevalence rates, and performance in the MECA study. Methods for Epidemiology of Child and Adolescent Mental Disorders Study. Journal of the American Academy of Child and Adolescent Psychiatry, 35 (7): 865-877.
Stein, S., Linn, M., Stein, EM. (1989). Psychological correlates of survival in nursing home cancer patients. Gerontologist, 29, 224-228.
Taylor, C, Bandura, A, Ewart, CK, Miller, NH, DeBusk, RF. (1985). Exercise testing to enhance wives’ confidence in their husbands’ cardiac capability soon after clinically uncomplicated acute myocardial infarction. American Journal of Cardiology, 55. 635-638
Watson M., Greer S., Rowden L., et al (1991). Relationships between emotional control, adjustment to cancer and depression and anxiety in breast cancer patients. Psychological Medicine (21) 51-57.
Zigmond, A and Snaith R (1983) The Hospital Anxiety and Depression Scale. Acta Psychiatry Scand. 67, pp361-370
Appendix A
Appendix E
Appendix F
Appendix G
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