Weight Management After Cancer for Survivors in Rural Communities

NCT07426952 | Suspended

• 1 other identifier: Pro00117620
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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 study team successfully recruit and keep participants in the study, and will the participants find the program helpful and easy to follow?
• Will participants who join the program see better results in areas like weight, symptoms, diet, physical activity, and confidence in managing the participant's health compared to those who receive standard care? Here's what participants will do:
• Visit the participant's clinic twice (about 12 weeks apart) to be weighed, have the blood pressure checked, give a blood sample, and complete a short walking test
• Fill out online surveys about the participant's health, diet, physical activity, symptoms, and confidence in managing the participant's 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

Conditions

Breast Cancer Survivorship; Weight Management; Cardiovascular (CV) Risk; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)

  Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the program they received. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."

  Post-treatment (about 12-14 weeks after baseline)

• Acceptability as measured by the Treatment Acceptability Questionnaire

  The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged.

  Post-treatment (about 12-14 weeks after baseline)

Secondary Outcomes (19)

• Change in blood pressure (systolic and diastolic)

  From Baseline to Post-treatment (about 12-14 weeks after baseline)

• Change in weight

  From Baseline to Post-treatment (about 12-14 weeks after baseline)

• Change in total cholesterol

  From Baseline to Post-treatment (about 12-14 weeks after baseline)

• Change in LDL cholesterol

  From Baseline to Post-treatment (about 12-14 weeks after baseline)

• Change in HDL cholesterol

  From Baseline to Post-treatment (about 12-14 weeks after baseline)

Other Outcomes (3)

• Food environment as measured by the Perceived Nutrition Environment Measure

  Baseline

• Assessment of rurality as measured by selected items from the Rural Active Living Perceived Support Scale

  Baseline

• Health literacy as measured by Medical Term Recognition Test (METER)

  Baseline

Study Arms (2)

WeCan-Rural

EXPERIMENTAL

Participants will receive the WeCan-Rural intervention, which includes twelve sessions delivered remotely (i.e., videoconferencing) by a trained therapist.

Behavioral: WeCan-Rural Program

Control

NO INTERVENTION

Participants will receive the National Cancer Institute-developed booklet "Facing Forward: Life After Cancer Treatment," which presents information about cancer survivorship topics.

Interventions

WeCan-Rural Program BEHAVIORAL

The WeCan-Rural program includes 12, one-hour weekly sessions via Zoom that help breast cancer survivors manage symptoms like pain, fatigue, and emotional distress, while also building healthy habits around eating, exercise, and weight management.

WeCan-Rural

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• visual, hearing or cognitive impairment or severe mental illness interfering with participation

Sponsors & Collaborators

• Duke University: lead

Study Sites (3)

Maria Parham Cancer Center

Henderson, North Carolina, 27536, United States

Location

Scotland Health

Laurinburg, North Carolina, 28352, United States

Location

UNC Health Southeastern

Lumberton, North Carolina, 28358, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Caroline Dorfman, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)