Support Group Program in Improving Quality of Life in Underserved Urban Latina Breast Cancer Survivors

Study Overview
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Brief Summary
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This randomized clinical trial studies a support group program in improving quality of life in underserved urban Latina breast cancer survivors. A psychosocial support group program may help reduce distress and improve health-related quality of life in underserved urban Latina breast cancer survivors.

Detailed Description
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PRIMARY OBJECTIVES: I. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of health-related quality of life. II. Evaluate the effect of the support program for Latina breast cancer survivors using validated measures of general distress. SECONDARY OBJECTIVES: I. A brief qualitative assessment will evaluate the perception of the program among intervention participants using a brief survey. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants attend support group sessions over 1-1.5 hours once weekly for 10 weeks. The sessions include facilitated discussions among participants about the following topics: stress management and emotional coping strategies, nutrition and physical activity, sexuality and body image, medical advocacy, self-care and social support. Participants receive a binder in which the rationale for each topic, techniques learned, and activities completed during each session will be summarized and are shown a Chair-robics digital video disc (DVD). ARM II: Participants receive one phone call to arrange a follow-up with the promotora, a note acknowledging their participation in the study, and a community resource booklet. Participants are then yoked into one of the 3 intervention groups and asked to attend a 30 minute session similar to Arm I.

Official Title
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Developing an Intervention to Reduce Stress and Improve Quality of Life in Underserved Urban Latina Breast Cancer Survivors

Conditions
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Breast Carcinoma, Cancer Survivor

Intervention / Treatment
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* Other: Informational Intervention
* Other: Informational Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Support Group Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Latino Spanish-speaking Diagnosed with breast cancer A current resident of either King, Snohomish or Pierce counties in Washington State with the intent of remaining a resident for at least 3 months following study enrollment Additionally, at time of enrollment, participants must be post-treatment (with the exception of adjuvant therapy) for their primary cancer and not actively undergoing treatment for a secondary, metastatic, or recurrence of cancer (local or distant) There will be no restrictions on time since diagnosis for participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (support group sessions)<br>Participants attend support group sessions over 1-1.5 hours once weekly for 10 weeks. The sessions include facilitated discussions among participants about the following topics: stress management and emotional coping strategies, nutrition and physical activity, sexuality and body image, medical advocacy, self-care and social support. Participants receive a binder in which the rationale for each topic, techniques learned, and activities completed during each session will be summarized and are shown a Chair-robics DVD. | Other: Informational Intervention<br>* Watch a Chair-robics DVD<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Support Group Therapy<br>* Attend support group sessions<br>|
| Active Comparator: Arm II (control)<br>Participants receive one phone call to arrange a follow-up with the promotora, a note acknowledging their participation in the study, and a community resource booklet. Participants are then yoked into one of the 3 intervention groups and asked to attend a 30 minute session similar to Arm I. | Other: Informational Intervention<br>* Receive community resource booklet<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence assessed using weekly attendance records | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Up to 10 weeks | 
| Change in acculturation to reflect language use and media, as well as ethnic social relationships, assessed using the Short Acculturation Scale for Hispanics | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in anxiety, measured using the Generalized Anxiety Disorder-7 | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in coping style, assessed using the Brief Cope scale | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in depression assessed using the Patient Health Questionnaire depression module-9 | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in distress assessed using the Distress Thermometer measure | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in fatigue assessed using the FACIT | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in Hispanic-specific stress measured using the abbreviated version of the Hispanic Stress Inventory-Immigrant version | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in perceived stress measured using the Perceived Stress Scale | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in quality of life as measured using the Functional Assessment Chronic Illness Therapy (FACIT)-General | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in self-efficacy measured using the Spanish Chronic Disease Self-Efficacy scale | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks | 
| Change in social support assessed using the Medical Outcomes Study-Social Support Survey | Skewed data will be log transformed or other appropriate transformations performed as necessary. Simple associations between demographic variables and outcome variables will be conducted to determine the need for control variables. Significant pre- to post-intervention change in psychosocial outcomes will be analyzed using the repeated measures linear mixed model. All analyses will be two-tailed and held to a significance level of alpha = 0.05. Post-hoc analyses will otherwise be conducted as appropriate pending the outcome of the initial primary analyses. | Baseline to up to 10 weeks |