Breast Cancer, Diabetes Mellitus, Non-Insulin-Dependent, Endometrial Cancer
Conditions
Keywords
Cancer, Breast Cancer, Endometrial cancer,, Type 2 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.
Interventions
BEHAVIORALStandard Behavioral Weight Change Intervention
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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 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 |
Outcome results
None listed