A Lifestyle Intervention for Breast Cancer Survivors (TTMI)

Hartford Hospital

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Standardized Lifestyle Management; Behavioral: Targeting the Teachable Moment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01819324

Park003382HE

5R21CA152129-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 3 patient groups

Targeting the Teachable Moment

Experimental group

Description:

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

Treatment:

Behavioral: Targeting the Teachable Moment

Standardized Lifestyle Management

Active Comparator group

Description:

Receiving Standardized Lifestyle Management materials (focusing mostly on health behaviors) every other week for 4 months

Treatment:

Behavioral: Standardized Lifestyle Management

Usual Care

No Intervention group

Description:

Receiving SLM materials at the end of the 7 months