Translating Healthy Lifestyle Interventions for Cancer Survivors

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

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