Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions (NCT06463249) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions
United States200 participantsStarted 2024-06-17
Plain-language summary
The objective of the HELPLINE Weight Loss Program is to determine the comparative effectiveness of two active multi-component, augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goal in the initial intervention period (termed, early non-responders). The core study design is randomized controlled trial with adaptive intervention.
1. CORE Helpline in all participants (first 2 months)
2. Extended Helpline in early responders (additional 6 months)
3. Enhanced Helpline in early non-responders (additional 6 months)
4. Intensive Helpline in early non-responders (additional 6 months)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women and men ages 18 or older
* Able to complete all study requirements in English
* Have been previously diagnosed with a malignant solid tumor, completed the required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.
* Have a BMI ≥ 27 kg/m2 (BMI ≥ 25 kg/m2 for Asians) and weight ≤ 400 lbs.
* Have an email address for regular personal use
* Have a smartphone for personal use, and are willing to use the phone to read emails and text messages, and use an app
* Have adequate data plan and cell service to support daily use of weight loss app, receive text messages and to support coaching calls
* Are willing to record weekly weights
* Are willing to use a tracking app to log food and exercise daily
* Are willing to complete coaching calls as planned
* Are willing to prioritize weight loss efforts by making dietary changes and increasing physical activity
Exclusion Criteria:
* Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed program date
* Women who are breastfeeding, pregnant, or planning pregnancy within the next year
* self-identification of uncontrolled concurre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms
Timeframe: 8 months
Trial details
NCT IDNCT06463249
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins