- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02690766
Translating Healthy Lifestyle Interventions for Cancer Survivors
May 12, 2023 updated by: University of North Carolina, Chapel Hill
Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes
Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Recent systematic reviews and meta-analyses of cohort studies show that physical activity can reduce mortality and morbidity in diabetes and obesity-related cancers.
Yet, there have been few efforts to promote physical activity within the context of female cancer survivorship, particularly among women with diabetes.
In response, investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African Americans (AA) with diabetes and who are breast or endometrial cancer survivors.
This web-based, lifestyle intervention, coupled with coaching calls and in-person exercise sessions, may be an effective way to promote physical activity and healthy survivorship.
The primary goal is for participants to participate in 30 minutes of moderate-to-vigorous physical activity five times a week.
The investigators' aims : i) refine a theory-driven healthy lifestyle intervention, that is delivered via computer technologies and periodic in-person group exercise sessions with appropriate content, literacy demand and graphics, ii) assess the preliminary effects of the intervention on the primary outcome of level of moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight, glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and acceptability on response to the intervention.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- African American women, ages 30
- No evidence of pregnancy, as evidenced by negative urine pregnancy test.
- Diagnosed with type 2 diabetes by their provider
- Diagnosed with Stage I-III breast or endometrial cancer
- Completed treatment for breast or endometrial cancer at least 4 months and no more 5 years ago English-speaking
- Agree to participate in all aspects of the semi-structured interview (Aim 1)
- Agree to participate in all aspects of the feasibility study, including group sessions (Aim 2)
- Access to the internet via phone or computer
- Access to a working phone for personal use
Exclusion Criteria:
- Non-English speaking
- Recent epilepsy, cardiac event or stroke in last 6 months,special nutritional needs (e.g. current evidence of malignancy; HIV)
- History of epilepsy, cardiac event or stroke within the last year
- Known diagnosis of HIV
- Known new malignancy
- Less than 4 months or more than 2 years post treatment of Stage I-III breast or endometrial cancer.
- No diagnosis of type 2 diabetes
- No self-report of African American race/ethnicity
- No access to a phone for personal use
- No access to the internet via computer or mobile phone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Physical Activity Group
The Success Study's Standard Behavioral Weight Change Intervention consists of 75 minute group sessions held monthly which include 30 minutes of physical activity with a licensed Physical Activity Instructor.
Web Lessons that include information on Physical Activity, Nutrition and Healthy Behaviors will also be provided to participants on the study's website.
|
Participants enrolled in Phase 2 of the study will meet once a month for 75 minutes over the course of 4 months.
Within this 75 minutes, they will complete 25 minutes of physical activity with a licensed physical activity instructor that is very experienced with working with this population, review and discuss various topics/lessons that relate to diabetes, nutrition, survivorship and physical activity with the study's interventionist and Group Leader
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: Week 0 and 16
|
Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period
|
Week 0 and 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wanda Nicholson, MD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
February 18, 2016
First Submitted That Met QC Criteria
February 18, 2016
First Posted (Estimate)
February 24, 2016
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 12, 2023
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0162
- P30DK093002 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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