A Lifestyle Intervention for Breast Cancer Survivors

Breast Cancer Clinical Trial

— TTMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819324
• Other study ID #: Park003382HE
• Secondary ID: 5R21CA152129-02
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: December 2, 2015
• Start date: April 2011
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: July 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Targeting the Teachable Moment
TTMI material (every other week for 4 months)
• Standardized Lifestyle Management
SLM material (every other week for 4 months)

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feedback of each module	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.	up to 4 months	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No