Translating Healthy Lifestyle Interventions for Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690766
• Other study ID #: 15-0162
• Secondary ID: P30DK093002
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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