Behavioral Weight Loss for Cancer Survivors in Maryland: A Trial With Adaptive Interventions

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Jun 12, 2024

Keywords

ClinConnect Summary

The HELPLINE Weight Loss Program is a clinical trial aimed at helping cancer survivors who are struggling with overweight or obesity. The study is looking to understand which of two different support strategies works best for those who initially have trouble losing weight. Everyone involved will first receive two months of standard help through a program called CORE Helpline. After that, those who start to lose weight will continue with an additional six months of support, while those who do not see early results will receive more intensive help over the same time frame.

To be eligible for this trial, participants should be at least 18 years old, have a history of a solid tumor cancer treated at least three months before joining, and have a body mass index (BMI) of 27 or higher (or 25 for Asian participants). They also need to have a smartphone and be comfortable using an app to track their weight, food, and exercise. Throughout the program, participants will record their weekly weight and join regular coaching calls to stay on track. This trial is currently recruiting, and it provides a supportive environment for cancer survivors to achieve their weight loss goals.

Gender

ALL

Eligibility criteria

• 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 concurrent medical condition likely to limit compliance with the program as determined by investigators.
• • current involvement in another organized weight loss program
• • current use of medications known to substantially affect body weight, including chronic oral steroids, Tirzepatide (Mounjaro™), and weight loss doses of other glucagon-like peptide 1 (GLP-1) agonists (e.g. Wegovy.)
• • bariatric surgery scheduled within the next 12 months
• • plan to move outside the continental United States in the next 12 months
• • Weight loss or gain of \>5.0% of body weight during 2 months prior to screening