Behavioral Weight Loss for Obese Cancer Survivors
(Helpline Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Must not be taking: Chronic steroids, GLP-1 agonists
Disqualifiers: Recent chemotherapy, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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)
Will I have to stop taking my current medications?
The trial requires that you stop taking medications known to substantially affect body weight, such as chronic oral steroids, Tirzepatide (Mounjaro™), and weight loss doses of other GLP-1 agonists (e.g., Wegovy).
What data supports the effectiveness of the HELPLINE Weight Loss Program treatment for obese cancer survivors?
Research shows that telephone-delivered weight loss programs can help breast cancer survivors lose weight and improve their quality of life. Additionally, tele-Motivational Interviewing has been found to be feasible and potentially effective for overweight cancer survivors.
12345Is the Behavioral Weight Loss Program safe for obese cancer survivors?
The weight loss programs reviewed, including those delivered by telephone, were found to be safe for women following breast cancer treatment, with no serious adverse events reported.
16789How is the HELPLINE Weight Loss Program treatment different from other treatments for obesity in cancer survivors?
The HELPLINE Weight Loss Program is unique because it focuses on behavioral lifestyle interventions that are based on theoretical frameworks, which are designed to help cancer survivors maintain weight loss over time. This approach is different from standard treatments as it emphasizes extended care and behavior change techniques to prevent weight regain, rather than just initial weight loss.
110111213Eligibility Criteria
This trial is for cancer survivors living in Maryland who are overweight or obese and haven't had success with initial weight loss efforts. Participants should be early non-responders to the CORE Helpline intervention, which all participants receive for the first two months.Inclusion Criteria
Are willing to complete coaching calls as planned
Are willing to prioritize weight loss efforts by making dietary changes and increasing physical activity
Able to complete all study requirements in English
+8 more
Exclusion Criteria
Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed program date
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
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
CORE Helpline
All participants receive the CORE Helpline program, including written materials, app instructions, weekly tips, and optional coaching calls
2 months
2 optional phone calls
Extended Helpline
Participants who achieve 2% weight loss continue with 1-on-1 coaching through participant-initiated calls
6 months
1 call per month
Enhanced Helpline
Early non-responders receive individualized feedback and participant-initiated calls
6 months
1 call per month, 2 emails per month
Intensive Helpline
Early non-responders receive scheduled coaching calls and individualized feedback
6 months
2 calls per month, 2 emails per month
Follow-up
Participants continue the program on their own and provide final weights
4 months
Participant Groups
The study tests two augmented interventions: Enhanced Helpline and Intensive Helpline, each lasting an additional six months. It aims to see which helps early non-responders lose weight more effectively after not meeting goals with just the CORE Helpline.
4Treatment groups
Experimental Treatment
Active Control
Group I: Intensive HelplineExperimental Treatment2 Interventions
Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.
Group II: Extended HelplineExperimental Treatment2 Interventions
Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months.
Group III: CORE HelplineExperimental Treatment1 Intervention
All participants will receive the CORE Helpline program for 2 months
Group IV: Enhanced HelplineActive Control2 Interventions
Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins ProHealthBaltimore, MD
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Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
Maryland Cigarette Restitution FundCollaborator
References
The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. [2022]Label="AIM" NlmCategory="OBJECTIVE">Obesity is associated with poor prognosis and risk of treatment side-effects in breast cancer survivors. This pilot study assessed the feasibility, acceptability, safety and efficacy of a telephone-delivered weight loss intervention, among women (BMI 25-40 kg/m2 ) following treatment for stage I-III breast cancer, on weight loss (primary outcome), quality of life and treatment-related side-effects (vs usual care).
Relationship of psychiatric diagnosis and weight loss maintenance in obese breast cancer survivors. [2007]Obese breast cancer survivors are a unique population for weight loss counseling because both obesity and a diagnosis of breast cancer can increase the risk of depression. In this pilot study, weight loss maintenance was examined in obese breast cancer survivors with relationship to psychiatric diagnosis.
Tele-Motivational Interviewing for Cancer Survivors: Feasibility, Preliminary Efficacy, and Lessons Learned. [2020]Determine the feasibility, acceptability, and efficacy of tele-Motivational Interviewing (MI) for overweight cancer survivors.
Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial. [2022]Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprising generic Weight Watchers® referral offered to women treated for breast cancer with or without additional breast cancer-tailored dietetic support is feasible and shows promise for improving weight and quality of life (QoL).
Bariatric surgery in cancer survivorship: does a history of cancer affect weight loss outcomes? [2018]Weight loss is recommended for obese cancer survivors who are at increased risk of recurrence and non-cancer-related mortality. It remains unknown if this vulnerable population benefits from bariatric surgery to the same extent as those without a history of cancer.
Weight loss intervention trials in women with breast cancer: a systematic review. [2022]Obesity has been associated with poor health outcomes in breast cancer survivors. Thus, weight loss is recommended for overweight and obese survivors. We systematically reviewed studies (published up to July 2013) that evaluated behaviourally based, weight loss interventions in women with breast cancer exclusively. Completed randomized trials, single-arm trials and ongoing trials were reviewed. Within-group and between-group differences for weight loss were extracted, as was data on secondary outcomes, i.e. clinical biomarkers, patient-reported outcomes, adverse events. Ten completed randomized trials, four single-arm trials and five ongoing trials were identified. Statistically significant within-group weight loss was observed over periods of 2 to 18 months in 13 of the 14 trials, with six randomized and two single-arm trials observing mean weight loss ≥5%. Clinical biomarkers, psychosocial and patient-reported outcomes were measured in a small number of studies. No serious adverse events were reported. Only two trials assessed maintenance of intervention effects after the end-of-intervention and none reported on cost-effectiveness. The studies included in this review suggest that weight loss is feasible to achieve and is safe in women following treatment for breast cancer. Future studies should assess (and be powered for) a range of biomarker and patient-reported outcomes, and be designed to inform translation into practice.
The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. [2023]The Breast Cancer Weight Loss (BWEL) trial is a randomized controlled trial designed to determine whether weight loss after a breast cancer diagnosis can reduce the risk of cancer recurrence in women with overweight or obesity. The BWEL trial will compare the efficacy of a telephone-based weight-loss intervention plus health education materials versus health education materials alone on invasive disease-free survival in 3,181 women with stage II or III breast cancer and BMI > 27 kg/m2 . This report provides a detailed description of the goals and methods of the lifestyle intervention and the evidence supporting the intervention used in the BWEL trial. The intervention's primary goal for participants is to achieve and maintain a weight loss ≥ 10% of baseline weight through increased physical activity and caloric restriction. The evidence supporting the diet, physical activity, and behavioral components of this telephone-based weight-loss intervention, as well as strategies to promote participant engagement and retention, is described. The intervention is provided through 42 sessions delivered by trained health coaches over a 2-year period. If the BWEL lifestyle intervention is successful in improving cancer outcomes, then weight loss will be incorporated into the care of thousands of breast cancer patients.
The effects of a clinic-based weight loss program on health-related quality of life and weight maintenance in cancer survivors: A randomized controlled trial. [2023]The Healthy Living and Eating After Cancer Trial demonstrated that a clinic-based weight loss program reduced body weight, as compared with a waitlist control group, over 15 weeks. Here we report the impact of the weight loss intervention on health-related quality-of-life outcomes at week 15, and maintenance of weight loss to week 30.
Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. [2021]Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is a 4-year randomized clinical trial of 693 overweight/obese women aged ≥21years diagnosed with any early stage breast cancer (stages I[≥1cm]-III) within the previous five years, designed to demonstrate the feasibility of achieving sustained weight loss and to examine the impact of weight loss on quality of life and co-morbidities, and to enable future exploration of biochemical mechanisms linking obesity to lower likelihood of disease-free survival. This trial is strategically designed as a vanguard for a fully-powered trial of women who will be evaluated for breast cancer recurrence and disease-free survival. Participants were recruited between 2010 and 2012 at four sites, had completed initial therapies, and had a body mass index between 25 and 45kg/m(2). The intervention featured a group-based cognitive-behavioral weight loss program with telephone counseling and tailored newsletters to support initial weight loss and subsequent maintenance, with the goal of 7% weight loss at two years. This study has high potential to have a major impact on clinical management and outcomes after a breast cancer diagnosis. This trial initiates the effort to establish weight loss support for overweight or obese breast cancer survivors as a new standard of clinical care.
Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. [2023]Updated evidence for the treatment of obesity in cancer survivors includes behavioural lifestyle interventions underpinning at least one theoretical framework. The aim of this systematic review was to assess the effectiveness of theory-based lifestyle interventions for the treatment of overweight/obesity in breast cancer survivors and to report effective behavioural change techniques (BCTs) and components used in these interventions.
Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. [2021]Behavioral interventions for obesity produce clinically meaningful weight loss, but weight regain following treatment is common. Extended care programs attenuate weight regain and improve weight loss maintenance. However, less is known about the most effective ways to deliver extended care, including contact schedules.
Toward the optimal strategy for sustained weight loss in overweight cancer survivors: a systematic review of the literature. [2018]To gain more insight into the optimal strategy to achieve weight loss and weight loss maintenance in overweight and obese cancer survivors after completion of initial treatment, this systematic review aimed to provide an overview of the literature on intervention effects on weight, to describe intervention components used in effective interventions, to identify and synthesize behaviour change techniques (BCTs) and to assess the frequency with which these BCTs were used in effective interventions.
Current treatment of obesity: a behavioral medicine perspective. [2005]Obesity is a complex biopsychosocial phenomenon. It has a profound effect on patients' physical and psychological health. Due to the complexity of the problem and the recidivism following treatment, it is recommended that obese patients receive in-depth interdisciplinary evaluation to match them appropriately to comprehensive treatment. Participation in an interdisciplinary comprehensive active weight loss treatment program followed by participation in a professionally led biweekly behavioral maintenance program that included social influence and aerobic exercise has generated maintenance of 83% of initial weight loss at an 18-month follow up. This comprehensive multi-disciplinary treatment approach, best offered in a behavioral medicine center setting, represents state-of-the-art treatment at this time and can result in long-term medical and psychological benefits for the obese patient.