Weight Management After Cancer for Survivors in Rural Communities (WeCan-Rural)

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

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

Study Overview

• Status: Suspended
• Conditions: Breast Cancer; Weight Management; Breast Cancer Survivorship; Cardiovascular (CV) Risk
• Intervention / Treatment: Behavioral: WeCan-Rural Program

Detailed Description

Breast cancer survivors often face long-term health challenges after treatment, including a higher risk of heart disease. This risk is especially high for women living in rural areas, where access to healthcare and healthy food may be limited, and opportunities for physical activity may be harder to find. Many survivors also deal with ongoing symptoms like pain, fatigue, and emotional distress, which can make it harder to eat well, stay active, and manage their weight.

This study will test a program called WeCan-Rural, designed to help breast cancer survivors improve their health and lower their risk of heart disease. The program teaches skills for healthy eating, physical activity, and managing symptoms that can get in the way of a healthy lifestyle. It includes 12 weekly sessions delivered remotely through Zoom, so participants can join from home. Each session lasts about an hour and covers topics like nutrition, exercise, and ways to cope with symptoms using strategies like relaxation and pacing.

Participants will receive tools to help them track their progress, including a wireless activity tracker, a scale, and a blood pressure monitor. They'll also get printed materials and access to online videos showing how to do recommended exercises. If needed, participants will be provided with a tablet and data plan to make sure they can join the sessions.

The study will include 40 breast cancer survivors who have completed treatment and are living in rural, medically underserved areas. Half will receive the WeCan-Rural program, and half will receive standard health information from the National Cancer Institute. Researchers will look at how easy it is to recruit and keep participants in the program, how satisfied participants are with it, and whether it helps improve the participant's weight, symptoms, diet, physical activity, and confidence in managing the participant's health. The study will also measure changes in heart health indicators like blood pressure, cholesterol, and blood sugar.

If the program is found to be helpful and well-received, it may be tested in a larger study in the future.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Henderson, North Carolina, United States, 27536
      • Maria Parham Cancer Center
    • Laurinburg, North Carolina, United States, 28352
      • Scotland Health
    • Lumberton, North Carolina, United States, 28358
      • UNC Health Southeastern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WeCan-Rural; Participants will receive the WeCan-Rural intervention, which includes twelve sessions delivered remotely (i.e., videoconferencing) by a trained therapist.	Behavioral: WeCan-Rural Program; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure (systolic and diastolic)	Both systolic and diastolic blood pressure will be assessed at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in weight	Participants will be weighed at each assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in total cholesterol	Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in LDL cholesterol	LDL cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in HDL cholesterol	HDL cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in hemoglobin A1c	Hemoglobin A1c will be assessed through peripheral blood at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in C-reactive protein	C-reactive protein will be assessed through peripheral blood at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in high sensitivity troponin	High sensitivity troponin will be assessed through peripheral blood at the baseline and follow-up assessment.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test	The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity. Higher values indicate higher aerobic capacity and endurance.	From Baseline to Post-treatment (about 12-14 weeks after baseline)
Pain severity and interference as measured by the Brief Pain Inventory	The Brief Pain Inventory will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). This measures includes a body map on which the patient can mark the location(s) in which they are experiencing pain, as well as 8 questions on a scale of 0 to 10 with higher scores indicating worse pain severity or pain interference.	Baseline, Post-treatment (about 12-14 weeks after baseline)
Emotional distress as measured by PROMIS Depression Short Form	Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).	Baseline, Post-treatment (about 12-14 weeks after baseline)
Emotional distress as measured by PROMIS Anxiety Short Form	Symptoms of Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).	Baseline, Post-treatment (about 12-14 weeks after baseline)
Fatigue as measured by PROMIS Fatigue Scale	Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5).	Baseline, Post-treatment (about 12-14 weeks after baseline)
Diet as measured by the Dietary Screener Questionnaire	The Dietary Screener Questionnaire is a 25-item measure asking participants to rate on the frequency of eating/drinking certain foods in the last week.	Baseline, Post-treatment (about 12-14 weeks after baseline)
Eating behavior as measured by the Three Factor Eating Questionnaire	Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.	Baseline, Post-treatment (about 12-14 weeks after baseline)
Physical activity as measured by the Stanford Leisure-Time Activity Categorical Item (L-Cat)	The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.	Baseline, Post-treatment (about 12-14 weeks after baseline)
Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale	The 6-item Self-Efficacy for Managing Chronic Illness Scale will be used to assess participants' current confidence in their ability to prevent symptoms (e.g., pain, fatigue, distress) from interfering with life. Responses are on a 10-point scale from "not at all confident" (1) to "totally confident" (10).	Baseline, Post-treatment (about 12-14 weeks after baseline)
Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form	The 4-item PROMIS Self-Efficacy for Managing Symptoms will be used to assess participants' confidence in their ability to manage symptoms (e.g. during daily activities, in a public place). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence.	Baseline, Post-treatment (about 12-14 weeks after baseline)
Weight-related self-efficacy as measured by the Weight Efficacy Lifestyle Questionnaire	The Weight Efficacy Lifestyle Questionnaire is an 8-item measure of eating self-efficacy. Participants are asked to provide information about how certain they are that they can resist overeating in difficult situation (e.g., over the weekend, when tired, etc.). Response choices range from 0= "not at all confident" to 10= "very confident."	Baseline, Post-treatment (about 12-14 weeks after baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy as measured by Medical Term Recognition Test (METER)	The METER will be used to assess health literacy. Participants are asked to review a list of 40 words and check off those that they recognize as actual words.	Baseline
Food environment as measured by the Perceived Nutrition Environment Measure	The Perceived Nutrition Environment Measure includes 53 core items to assess three types of perceived nutrition environments: community nutrition environment, consumer nutrition environment, and home food environment.	Baseline
Assessment of rurality as measured by selected items from the Rural Active Living Perceived Support Scale		Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Caroline Dorfman, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00117620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No