Breast CancerTTMINCT01819324
A Lifestyle Intervention for Breast Cancer Survivors
A study testing Targeting the Teachable Moment and Standardized Lifestyle Management in people with Breast Cancer, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Targeting the Teachable Moment and Standardized Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- apparent serious mental disturbance
- male breast cancer survivors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Targeting the Teachable Moment: A Lifestyle Intervention for Breast Cancer Survivors
- 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.
- 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.
- Conditions
- Breast Cancer
- Being tested
- Targeting the Teachable Moment, Standardized Lifestyle Management
- Keywords
- breast cancer survivors, lifestyle intervention, health behaviors
- Medical subject headings
- Breast Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeting the Teachable MomentBehavioural
Also called TTMI
TTMI material (every other week for 4 months)
Standardized Lifestyle ManagementBehavioural
Also called SLM
SLM material (every other week for 4 months)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Standardized Lifestyle Management |
| Usual Care | No intervention | Receiving SLM materials at the end of the 7 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Meaured at baseline, 4 months, and 7 months
Secondary outcomes (4)
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.
Measured: Measured at baseline, 4 months, and 7 months
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
Measured: Measured at baseline, 4 months, and 7 months
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
Measured: Measured at baseline, 4 months, and 7 months
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.
Measured: Measured at baseline, 4 months, and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2011
- Primary completionNov 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Crystal L. Park, Ph.D, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819324
- Sponsor's protocol ID
- Park003382HE
- Other IDs
- 5R21CA152129-02
- Acronym
- TTMI
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Teachable Moment: A Lifestyle Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01819324
- Acronym / sponsor ID
- TTMI / Park003382HE
- Conditions
- Breast Cancer
- Keywords
- breast cancer survivors, lifestyle intervention, health behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Targeting the Teachable Moment | Experimental | Behavioral: Targeting the Teachable MomentReceiving Targeting the Teachable Moment Intervention materials (focusing on health behaviors and issues specific to breast cancer survivors) every other week for 4 months |
| Standardized Lifestyle Management | Active comparator | Behavioral: Standardized Lifestyle ManagementReceiving Standardized Lifestyle Management materials (focusing mostly on health behaviors) every other week for 4 months |
| Usual Care | No intervention | –Receiving SLM materials at the end of the 7 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- apparent serious mental disturbance
- male breast cancer survivors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeting the Teachable MomentAlso: TTMITTMI material (every other week for 4 months) | Behavioural | Targeting the Teachable Moment |
| Standardized Lifestyle ManagementAlso: SLMSLM material (every other week for 4 months) | Behavioural | Standardized Lifestyle Management |
Primary outcome
Changes in eating habits measured by the National Cancer Institute Quick Food Scan
Time frame: Meaured at baseline, 4 months, and 7 months
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.
Changes in physical activity measured by the Paffenbarger physical activity questionnaire
Time frame: Meaured at baseline, 4 months, and 7 months
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.
4 secondary outcomes
Changes in coping strategies measured by the Brief COPE
Time frame: Measured at baseline, 4 months, and 7 months
Changes in Self-efficacy measured by the General Self-Efficacy Scale
Time frame: Measured at baseline, 4 months, and 7 months
Changes in social support measured by the Interpersonal Support Evaluation List (ISEL)
Time frame: Measured at baseline, 4 months, and 7 months
Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ)
Time frame: Measured at baseline, 4 months, and 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal L. Park, Ph.D principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeting the Teachable Moment and Standardized Lifestyle Management in people with Breast Cancer, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in eating habits measured by the National Cancer Institute Quick Food Scan (time frame: Meaured at baseline, 4 months, and 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.