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

NCT02521961 | Completed

• 3 other identifiers: 9425NCI-2015-01183P30CA015704
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Cancer Survivor

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Arm I (support group sessions)

EXPERIMENTAL

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Support Group Therapy

Arm II (control)

ACTIVE COMPARATOR

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Informational Intervention OTHER

Watch a Chair-robics DVD

Arm I (support group sessions)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (support group sessions); Arm II (control)

Questionnaire Administration OTHER

Ancillary studies

Arm I (support group sessions); Arm II (control)

Support Group Therapy PROCEDURE

Attend support group sessions

Arm I (support group sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel Ceballos

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 13, 2015
• Study Start: February 3, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (1)