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Completed

NCT Number: NCT01819324

A Lifestyle Intervention for Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Health Behavior Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeting the Teachable Moment

Behavioral

TTMI material (every other week for 4 months)

Other names: TTMI

Standardized Lifestyle Management

Behavioral

SLM material (every other week for 4 months)

Other names: SLM

Primary outcomes

  1. Changes in eating habits measured by the National Cancer Institute Quick Food Scan

    Time frame: 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.

  2. Changes in physical activity measured by the Paffenbarger physical activity questionnaire

    Time frame: 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 outcomes

  1. Changes in coping strategies measured by the Brief COPE

    Time frame: 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.

  2. Changes in Self-efficacy measured by the General Self-Efficacy Scale

    Time frame: 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

  3. Changes in social support measured by the Interpersonal Support Evaluation List (ISEL)

    Time frame: 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

  4. Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ)

    Time frame: 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.

Other outcomes

  1. Feedback of each module

    Time frame: up to 4 months

    usefulness of each module (e.g., whether each intervention is helpful or not) will be assessed at each mailing (for eight times) for 4 months.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: TTMI

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Mar 27, 2013
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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