Translating Healthy Lifestyle Interventions for Cancer Survivors

NCT ID: NCT02690766

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Physical Activity Group

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.

Group Type: OTHER

Standard Behavioral Weight Change Intervention

Intervention Type: 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

Interventions

Standard 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wanda Nicholson, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Other Identifiers

P30DK093002

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-0162

Identifier Type: -

Identifier Source: org_study_id