Translating Healthy Lifestyle Interventions for Cancer Survivors
Primary Purpose
Diabetes Mellitus, Non-Insulin-Dependent, Breast Cancer, Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard Behavioral Weight Change Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Non-Insulin-Dependent focused on measuring Cancer, Breast Cancer, Endometrial cancer,, Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Physical Activity Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Body Weight
Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period
Secondary Outcome Measures
Full Information
NCT ID
NCT02690766
First Posted
February 18, 2016
Last Updated
May 12, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02690766
Brief Title
Translating Healthy Lifestyle Interventions for Cancer Survivors
Official Title
Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent, Breast Cancer, Endometrial Cancer
Keywords
Cancer, Breast Cancer, Endometrial cancer,, Type 2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Change Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period
Time Frame
Week 0 and 16
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda Nicholson, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Translating Healthy Lifestyle Interventions for Cancer Survivors
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