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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
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    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)
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    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

    Learn more about this trial

    Translating Healthy Lifestyle Interventions for Cancer Survivors

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