Clinical trial NCT01819324: A Lifestyle Intervention for Breast Cancer Survivors
Official title: Targeting the Teachable Moment: A Lifestyle Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer survivors
lifestyle intervention
health behaviors
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-27
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in eating habits measured by the National Cancer Institute Quick Food Scan
timeFrame: Meaured at baseline, 4 months, and 7 months
measure: Changes in physical activity measured by the Paffenbarger physical activity questionnaire
timeFrame: Meaured at baseline, 4 months, and 7 months
Secondary outcomes:
measure: Changes in coping strategies measured by the Brief COPE
timeFrame: Measured at baseline, 4 months, and 7 months
measure: Changes in Self-efficacy measured by the General Self-Efficacy Scale
timeFrame: Measured at baseline, 4 months, and 7 months
measure: Changes in social support measured by the Interpersonal Support Evaluation List (ISEL)
timeFrame: Measured at baseline, 4 months, and 7 months
measure: Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ)
timeFrame: Measured at baseline, 4 months, and 7 months
Other outcomes:
measure: Feedback of each module
timeFrame: up to 4 months
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Crystal L. Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: