A Lifestyle Intervention for Breast Cancer Survivors

NCT ID: NCT01819324

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Targeting the Teachable Moment

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

Group Type EXPERIMENTAL

Targeting the Teachable Moment

Intervention Type BEHAVIORAL

TTMI material (every other week for 4 months)

Standardized Lifestyle Management

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

Group Type ACTIVE_COMPARATOR

Standardized Lifestyle Management

Intervention Type BEHAVIORAL

SLM material (every other week for 4 months)

Usual Care

Receiving SLM materials at the end of the 7 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Targeting the Teachable Moment

TTMI material (every other week for 4 months)

Intervention Type BEHAVIORAL

Standardized Lifestyle Management

SLM material (every other week for 4 months)

Intervention Type BEHAVIORAL

Other Intervention Names

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TTMI SLM

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Crystal L. Park, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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5R21CA152129-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Park003382HE

Identifier Type: -

Identifier Source: org_study_id