Clinical trial NCT02521961: Support Group Program in Improving Quality of Life in Underserved Urban Latina Breast Cancer Survivors
Official title: Developing an Intervention to Reduce Stress and Improve Quality of Life in Underserved Urban Latina Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Cancer Survivor
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence assessed using weekly attendance records
timeFrame: Up to 10 weeks
measure: Change in acculturation to reflect language use and media, as well as ethnic social relationships, assessed using the Short Acculturation Scale for Hispanics
timeFrame: Baseline to up to 10 weeks
measure: Change in anxiety, measured using the Generalized Anxiety Disorder-7
timeFrame: Baseline to up to 10 weeks
measure: Change in coping style, assessed using the Brief Cope scale
timeFrame: Baseline to up to 10 weeks
measure: Change in depression assessed using the Patient Health Questionnaire depression module-9
timeFrame: Baseline to up to 10 weeks
measure: Change in distress assessed using the Distress Thermometer measure
timeFrame: Baseline to up to 10 weeks
measure: Change in fatigue assessed using the FACIT
timeFrame: Baseline to up to 10 weeks
measure: Change in Hispanic-specific stress measured using the abbreviated version of the Hispanic Stress Inventory-Immigrant version
timeFrame: Baseline to up to 10 weeks
measure: Change in perceived stress measured using the Perceived Stress Scale
timeFrame: Baseline to up to 10 weeks
measure: Change in quality of life as measured using the Functional Assessment Chronic Illness Therapy (FACIT)-General
timeFrame: Baseline to up to 10 weeks
measure: Change in self-efficacy measured using the Spanish Chronic Disease Self-Efficacy scale
timeFrame: Baseline to up to 10 weeks
measure: Change in social support assessed using the Medical Outcomes Study-Social Support Survey
timeFrame: Baseline to up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rachel Ceballos
role: PRINCIPAL_INVESTIGATOR
References: