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CompletedNCT01819324TTMIUpdated Dec 3, 2015

A Lifestyle Intervention for Breast Cancer Survivors

An interventional study of Targeting the Teachable Moment and Standardized Lifestyle Management in Breast Cancer, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer survivors
  • lifestyle intervention
  • health behaviors
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 173 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • apparent serious mental disturbance
  • male breast cancer survivors
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
173 participants (actual)

Study arms

  • Experimental
    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

    Behavioral: Targeting the Teachable Moment

  • Active comparator
    Standardized Lifestyle Management

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

    Behavioral: Standardized Lifestyle Management

  • No intervention
    Usual Care

    Receiving SLM materials at the end of the 7 months

Interventions

  • BehavioralTargeting the Teachable Moment

    TTMI material (every other week for 4 months)

    Also known as: TTMI

  • BehavioralStandardized Lifestyle Management

    SLM material (every other week for 4 months)

    Also known as: SLM

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Meaured at baseline, 4 months, and 7 months

  2. 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.

    Time frame: Meaured at baseline, 4 months, and 7 months

Secondary outcomes

  1. 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.

    Time frame: Measured at baseline, 4 months, and 7 months

  2. 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

    Time frame: Measured at baseline, 4 months, and 7 months

  3. 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

    Time frame: Measured at baseline, 4 months, and 7 months

  4. 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.

    Time frame: Measured at baseline, 4 months, and 7 months

Other outcomes

  1. 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.

    Time frame: up to 4 months

07

Study locations

1 site
  • University of Connecticut
    Storrs, Connecticut 06269, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01819324
Lead sponsor
Hartford Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 27, 2013
Start date
Apr 2011
Primary completion
Nov 2013
Completion
Jul 2015
Last update
Dec 3, 2015

Study contacts

Crystal L. Park, Ph.D
principal investigator · University of Connecticut

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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