Health TrialsbyHealthPanel

Weight Management After Cancer for Survivors in Rural Communities

ConditionsBreast Cancer SurvivorshipWeight ManagementCardiovascular (CV) RiskBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: WeCan-RuralExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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."

Time frame
Post-treatment (about 12-14 weeks after baseline)
2

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.

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

Secondary outcomes

1

Change in blood pressure (systolic and diastolic)

Both systolic and diastolic blood pressure will be assessed at the baseline and follow-up assessment.

Time frame
From Baseline to Post-treatment (about 12-14 weeks after baseline)
2

Change in weight

Participants will be weighed at each assessment.

Time frame
From Baseline to Post-treatment (about 12-14 weeks after baseline)
3

Change in total cholesterol

Cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.

Time frame
From Baseline to Post-treatment (about 12-14 weeks after baseline)
4

Change in LDL cholesterol

LDL cholesterol will be assessed through peripheral blood at the baseline and follow-up assessment.

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

Other outcomes

1

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.

Time frame
Baseline
2

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

Time frame
Baseline
3

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, yielding a total score from 0 to 40. 0-20 points: Low health literacy; 21-34 points: Marginal health literacy; 35-40 points: Adequate health literacy

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov
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