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Development and Pilot Testing of a Novel Intervention to Reduce Cardiovascular Disease Risk Among Breast Cancer Survivors Living in Rural, Medically Underserved Communities

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is testing a new program called WeCan-Rural, designed to help breast cancer survivors manage symptoms and build healthy habits like eating well, staying active, and managing their weight. These changes may help lower the risk of heart disease after cancer treatment. The study will answer two main questions: * Can we successfully recruit and keep participants in the study, and will they find the program helpful and easy to follow? * Will people who join the program see better results in areas like weight, symptoms, diet, physical activity, and confidence in managing their health compared to those who receive standard care? Here's what participants will do: * Visit their clinic twice (about 12 weeks apart) to be weighed, have their blood pressure checked, give a blood sample, and complete a short walking test * Fill out online surveys about their health, diet, physical activity, symptoms, and confidence in managing their health * Be randomly assigned (like flipping a coin) to either receive the WeCan-Rural program or standard health information * If assigned to the program, attend 12 weekly one-hour video sessions on Zoom with a trained therapist

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• aged 18 years or older

• female (biological sex)

• diagnosis of stage I-III breast cancer

• completed treatments with curative intent (with the exception of hormonal treatments) in the last 5 years

• body mass index \>30

• healthy enough to participate in home-based physical activity

• able to speak/read English

• reports rating of ≥4 (i.e., moderate or more severe) out of 10 for one or more of the following symptoms at its worst in the last month (per the MD Anderson Symptom Inventory): pain, fatigue, sadness, and/or distress

Locations
United States
North Carolina
Maria Parham Cancer Center
RECRUITING
Henderson
Scotland Health
RECRUITING
Laurinburg
UNC Health Southeastern
RECRUITING
Lumberton
Contact Information
Primary
Smrithi Divakaran, MPH
smrithi.divakaran@duke.edu
919-681-7695
Backup
Michael W Willis
michael.w.willis@duke.edu
919-681-8437
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Experimental: WeCan-Rural
Participants will receive the WeCan-Rural intervention, which includes twelve sessions delivered remotely (i.e., videoconferencing) by a trained therapist.
No_intervention: Control
Participants will receive the National Cancer Institute-developed booklet Facing Forward: Life After Cancer Treatment, which presents information about cancer survivorship topics.
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov