Clinical trial NCT02690766: Translating Healthy Lifestyle Interventions for Cancer Survivors
Official title: Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Breast Cancer
Endometrial Cancer
Keywords: Cancer
Breast Cancer
Endometrial cancer,
Type 2 Diabetes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-02-24
Enrollment: 17
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Week 0 and 16
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Wanda Nicholson, MD
role: PRINCIPAL_INVESTIGATOR
References: