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Completed

NCT Number: NCT02690766

Translating Healthy Lifestyle Interventions for Cancer Survivors

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Behavioral Weight Change Intervention

Behavioral

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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