Translating Healthy Lifestyle Interventions for Cancer Survivors

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Endometrial Cancer
Breast Cancer
Diabetes Mellitus, Non-Insulin-Dependent

Treatments

Behavioral: Standard Behavioral Weight Change Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02690766
15-0162
P30DK093002 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

Female

Ages

30 to 99 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Physical Activity Group
Other 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.
Treatment:
Behavioral: Standard Behavioral Weight Change Intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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