A Lifestyle Intervention for Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Targeting the Teachable Moment; Behavioral: Standardized Lifestyle Management

• Registration Number: NCT01819324
• Lead Sponsor: Hartford Hospital

Brief Summary

1. The purpose of the study is to test the effectiveness of a new mail-based intervention for breast cancer survivors compared with standard lifestyle management and no-treatment.

2. This intervention addresses both lifestyle factors such as dietary and physical activities and psychological issues specific to breast cancer survivors to improve healthy behaviors.

Detailed Description

Participants will be assigned randomly to one of three groups: 1) newly developed mail-based intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however TTMI additionally addresses psychosocial issues specific to breast cancer survivors.

All participants will complete questionnaires at the time they start the study, the end of the 4 months, and 3 months later for a follow-up.

If participants are assigned to any of the intervention group, they will receive materials every other week for 4 months. If participants are assigned to the usual care group, they will receive the same materials as the standard lifestyle intervention et the end of the 7 months.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-27
• Primary Completion: 2013-11
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 173

Inclusion Criteria

• First diagnosed with breast cancer in the past 1.5 years
• stage 0~2 breast cancer
• no prior adjuvant treatment for another cancer
• Can read and write English
• Are not participating in other health behavior research right now

Exclusion Criteria

• apparent serious mental disturbance
• male breast cancer survivors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeting the Teachable Moment	Targeting the Teachable Moment	Receiving Targeting the Teachable Moment Intervention materials (focusing on health behaviors and issues specific to breast cancer survivors) every other week for 4 months
Standardized Lifestyle Management	Standardized Lifestyle Management	Receiving Standardized Lifestyle Management materials (focusing mostly on health behaviors) every other week for 4 months

Primary Outcome Measures

Name	Time	Method
Changes in eating habits measured by the National Cancer Institute Quick Food Scan	Meaured at baseline, 4 months, and 7 months	Diet habits (amount of fat and fruit/vegetable uptake) will be assessed at 3 times: at baseline, at the end of the 4 months, and at the end of 7 months.
Changes in physical activity measured by the Paffenbarger physical activity questionnaire	Meaured at baseline, 4 months, and 7 months	Frequency and amount of time for physical exercise will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months.

Secondary Outcome Measures

Name	Time	Method
Changes in coping strategies measured by the Brief COPE	Measured at baseline, 4 months, and 7 months	Coping strategies (e.g., problem-focused coping, emotional approach coping) will be assessed at 3 times: at baseline, at the end of the 4 months, and at the end of 7 months.
Changes in Self-efficacy measured by the General Self-Efficacy Scale	Measured at baseline, 4 months, and 7 months	A general sense of perceived self-efficacy will be measured at 3 times: at the baseline, at the end of 4 months, and at the end of 7 months
Changes in social support measured by the Interpersonal Support Evaluation List (ISEL)	Measured at baseline, 4 months, and 7 months	Social support will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months
Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ)	Measured at baseline, 4 months, and 7 months	Presence of Meaning and Search for Meaning will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months.

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States