Breast Cancer, Breast Cancer Survivorship, Cardiovascular (CV) Risk, Weight Management
Conditions
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
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.
Interventions
BEHAVIORALWeCan-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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) | Post-treatment (about 12-14 weeks after baseline) | 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." |
| Acceptability as measured by the Treatment Acceptability Questionnaire | Post-treatment (about 12-14 weeks after baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | From Baseline to Post-treatment (about 12-14 weeks after baseline) | Participants will be weighed at each assessment. |
| Change in total cholesterol | From Baseline to Post-treatment (about 12-14 weeks after baseline) | Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment. |
| Change in LDL cholesterol | From Baseline to Post-treatment (about 12-14 weeks after baseline) | LDL cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment. |
| Change in HDL cholesterol | From Baseline to Post-treatment (about 12-14 weeks after baseline) | HDL cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment. |
| Change in hemoglobin A1c | From Baseline to Post-treatment (about 12-14 weeks after baseline) | Hemoglobin A1c will be assessed through peripheral blood at the baseline and follow-up assessment. |
| Change in C-reactive protein | From Baseline to Post-treatment (about 12-14 weeks after baseline) | C-reactive protein will be assessed through peripheral blood at the baseline and follow-up assessment. |
| Change in high sensitivity troponin | From Baseline to Post-treatment (about 12-14 weeks after baseline) | High sensitivity troponin will be assessed through peripheral blood at the baseline and follow-up assessment. |
| Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test | From Baseline to Post-treatment (about 12-14 weeks after baseline) | 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. |
| Pain severity and interference as measured by the Brief Pain Inventory | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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. |
| Emotional distress as measured by PROMIS Depression Short Form | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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). |
| Emotional distress as measured by PROMIS Anxiety Short Form | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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). |
| Fatigue as measured by PROMIS Fatigue Scale | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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). |
| Diet as measured by the Dietary Screener Questionnaire | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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. |
| Eating behavior as measured by the Three Factor Eating Questionnaire | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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. |
| Physical activity as measured by the Stanford Leisure-Time Activity Categorical Item (L-Cat) | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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. |
| Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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). |
| Weight-related self-efficacy as measured by the Weight Efficacy Lifestyle Questionnaire | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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." |
| Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form | Baseline, Post-treatment (about 12-14 weeks after baseline) | 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. |
| Change in blood pressure (systolic and diastolic) | From Baseline to Post-treatment (about 12-14 weeks after baseline) | Both systolic and diastolic blood pressure will be assessed at the baseline and follow-up assessment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCaroline Dorfman, PhD
Duke University
CONTACTSmrithi Divakaran, MPH
CONTACTMichael W Willis
Outcome results
None listed