NCT01819324

Brief Summary

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

March 18, 2013

Last Update Submit

December 2, 2015

Conditions

Breast Cancer

Keywords

breast cancer survivorslifestyle interventionhealth behaviors

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

  • Changes in coping strategies measured by the Brief COPE

    Measured at baseline, 4 months, and 7 months

  • Changes in Self-efficacy measured by the General Self-Efficacy Scale

    Measured at baseline, 4 months, and 7 months

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

    Measured at baseline, 4 months, and 7 months

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

    Measured at baseline, 4 months, and 7 months

Other Outcomes (1)

  • Feedback of each module

    up to 4 months

Study Arms (3)

Targeting the Teachable Moment

EXPERIMENTAL

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

Behavioral: Targeting the Teachable Moment

Standardized Lifestyle Management

ACTIVE COMPARATOR

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

Behavioral: Standardized Lifestyle Management

Usual Care

NO INTERVENTION

Receiving SLM materials at the end of the 7 months

Interventions

Targeting the Teachable MomentBEHAVIORAL

TTMI material (every other week for 4 months)

Also known as: TTMI
Targeting the Teachable Moment
Standardized Lifestyle ManagementBEHAVIORAL

SLM material (every other week for 4 months)

Also known as: SLM
Standardized Lifestyle Management

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • apparent serious mental disturbance
  • male breast cancer survivors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Crystal L. Park, Ph.D

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 27, 2013

Study Start

April 1, 2011

Primary Completion

November 1, 2013

Study Completion

July 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)