A Lifestyle Intervention for Breast Cancer Survivors

Study Overview
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Brief Summary
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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. 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
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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.

Official Title
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Targeting the Teachable Moment: A Lifestyle Intervention for Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Targeting the Teachable Moment
* Behavioral: Standardized Lifestyle Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeting the Teachable Moment<br>Receiving Targeting the Teachable Moment Intervention materials (focusing on health behaviors and issues specific to breast cancer survivors) every other week for 4 months | Behavioral: Targeting the Teachable Moment<br>* TTMI material (every other week for 4 months)<br>* Other names: TTMI;|
| Active Comparator: Standardized Lifestyle Management<br>Receiving Standardized Lifestyle Management materials (focusing mostly on health behaviors) every other week for 4 months | Behavioral: Standardized Lifestyle Management<br>* SLM material (every other week for 4 months)<br>* Other names: SLM;|
| No Intervention: Usual Care<br>Receiving SLM materials at the end of the 7 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in eating habits measured by the National Cancer Institute Quick Food Scan | 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. | Meaured at baseline, 4 months, and 7 months | 
| Changes in physical activity measured by the Paffenbarger physical activity questionnaire | 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. | Meaured at baseline, 4 months, and 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in coping strategies measured by the Brief COPE | 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. | Measured at baseline, 4 months, and 7 months | 
| Changes in Self-efficacy measured by the General Self-Efficacy Scale | 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 | Measured at baseline, 4 months, and 7 months | 
| Changes in social support measured by the Interpersonal Support Evaluation List (ISEL) | Social support will be measured at 3 times: at baseline, at the end of 4 months, and at the end of 7 months | Measured at baseline, 4 months, and 7 months | 
| Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ) | 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. | Measured at baseline, 4 months, and 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer survivors, lifestyle intervention, health behaviors