NCT03719677

Reducing Metabolic Syndrome Among Breast Cancer Survivors

Reducing Metabolic Syndrome and Unmet Needs Among Rural Breast Cancer Survivors During the Survivorship Transition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural breast cancer survivors (BCS) (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit tele phone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs.

Detailed description

The objective of the present study is to determine the feasibility of a manual, theory based, occupational therapist delivered, preventative intervention to increase habit development (HD) of healthy dietary and physical activity behaviors, and reduce metabolic syndrome (MetS) among high-risk, rural breast cancer survivors (BCS). Using a pilot 1-arm pre-post design, investigators will implement an intervention that is personalized, low burden (the majority of interactions are telephone coaching sessions), and delivered during the initial survivorship transition. To determine the feasibility of the intervention 48 community-dwelling rural BCS (ages 40 and older) will receive the intervention. The 12-week intervention consists of three home-based face-to-face consultations with the therapist, 9 weekly habit telephone coaching sessions, and the use of implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habit formation and address unmet needs. Feasibility metrics will be collected throughout the intervention. The one specific aim is: Aim 1. To determine the feasibility and acceptability of the intervention for rural BCS. Investigators will evaluate recruitment, trial engagement and retention rates, treatment satisfaction, and the feasibility of the data collection processes for the primary behavioral measures of HD.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Habit development intervention	Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning

Timeline

• Start date: 2018-11-06
• Primary completion: 2020-06-01
• Completion: 2020-09-13
• First posted: 2018-10-25
• Last updated: 2020-11-20
• Results posted: 2020-11-20

Locations

1 site across 1 country: United States