Translating Healthy Lifestyle Interventions for Cancer Survivors

NCT02690766 | Completed DMC

• 2 other identifiers: 15-0162P30DK093002
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Cancer; Breast Cancer; Endometrial cancer,; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period

  Week 0 and 16

Study Arms (1)

Physical Activity Group

OTHER

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.

Behavioral: Standard Behavioral Weight Change Intervention

Interventions

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

Physical Activity Group

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Breast Neoplasms; Endometrial Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Wanda Nicholson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 16, 2023

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share