Brief Title
Translating Healthy Lifestyle Interventions for Cancer Survivors
Official Title
Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes
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.
Study Type
Interventional
Primary Outcome
Change in Body Weight
Condition
Diabetes Mellitus, Non-Insulin-Dependent
Intervention
Standard Behavioral Weight Change Intervention
Study Arms / Comparison Groups
Physical Activity Group
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
17
Start Date
March 2015
Completion Date
May 2016
Primary Completion Date
May 2016
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
Gender
Female
Ages
30 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Wanda Nicholson, MD, ,
Administrative Informations
NCT ID
NCT02690766
Organization ID
15-0162
Secondary IDs
P30DK093002
Responsible Party
Sponsor
Study Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor
Wanda Nicholson, MD, Principal Investigator, University of North Carolina, Chapel Hill
Verification Date
July 2019