Behavioral Weight Loss for Obese Cancer Survivors

(Helpline Trial)

Overseen By Linda Bunyard, MS, RD

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

200 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 10 11 12 13}

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)

Research Team

Jessica Yeh, PhD

Principal Investigator

Johns Hopkins University

Eligibility 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

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

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

Treatment Details

Interventions

• HELPLINE Weight Loss Program

Trial Overview 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.

Participant Groups

Group I: Intensive Helpline Experimental Treatment 2 Interventions

Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months.

Group II: Extended Helpline Experimental Treatment 2 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 Helpline Experimental Treatment 1 Intervention

All participants will receive the CORE Helpline program for 2 months

Group IV: Enhanced Helpline Active Control 2 Interventions

Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Maryland Cigarette Restitution Fund

Collaborator

Trials

10

Recruited

900+

Findings from Research

A telephone-delivered weight loss intervention for women with a BMI of 25-40 kg/m2 after breast cancer treatment resulted in a significant average weight loss of 3.1 kg compared to usual care, demonstrating its efficacy.

The intervention was found to be feasible and acceptable, with high participant satisfaction, and only one reported adverse event, indicating it is a safe option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. Reeves, M., Winkler, E., Mccarthy, N., et al.[2022]

In a pilot study of 48 obese breast cancer survivors over 24 months, those with psychiatric disorders lost significantly less weight (1.2% at 30 months) compared to those without such disorders (7.8% weight loss), indicating that mental health can impact weight loss efforts.

The study highlights the importance of recognizing and treating psychiatric disorders in cancer survivors, as these conditions may hinder successful weight management and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of psychiatric diagnosis and weight loss maintenance in obese breast cancer survivors. Jenkins, I., Djuric, Z., Darga, L., et al.[2007]

Tele-Motivational Interviewing (MI) is a feasible and acceptable intervention for overweight cancer survivors, with 29 participants completing the six-month study, primarily consisting of female breast cancer survivors.

Participants who engaged in tele-MI lost more weight (4.8 kg) and showed significant improvements in quality of life compared to nonusers, indicating its potential efficacy in promoting healthier behaviors among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Motivational Interviewing for Cancer Survivors: Feasibility, Preliminary Efficacy, and Lessons Learned. Braun, A., Portner, J., Grainger, EM., et al.[2020]

A pilot study involving 45 women treated for breast cancer showed that a Weight Watchers® referral program led to significant weight loss, with the Weight Watchers group losing an average of 6.03 kg by trial exit, compared to a slight gain in the control group.

The study found that while all groups showed improvements in quality of life, only the Weight Watchers group maintained significant weight loss benefits at 12 months, suggesting that the program is effective for weight management in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Newlands, RSN., Ntessalen, M., Clark, J., et al.[2022]

A study involving 29 cancer survivors who underwent bariatric surgery showed that they lost a similar amount of weight (14.2 kg) compared to matched patients without a history of cancer (14.8 kg) one year after surgery, indicating that bariatric surgery may be equally beneficial for both groups.

Although the weight loss difference was not statistically significant, these preliminary findings suggest that cancer survivors can benefit from bariatric surgery, highlighting the need for larger studies to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric surgery in cancer survivorship: does a history of cancer affect weight loss outcomes? Philip, EJ., Torghabeh, MH., Strain, GW.[2018]

A systematic review of 14 trials involving weight loss interventions for women with breast cancer found that significant weight loss (≥5%) was achieved in several studies, indicating that weight management is feasible for this population.

The interventions were deemed safe, with no serious adverse events reported, suggesting that behaviorally based weight loss strategies can be safely implemented in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss intervention trials in women with breast cancer: a systematic review. Reeves, MM., Terranova, CO., Eakin, EG., et al.[2022]

The BWEL trial is a large randomized controlled study involving 3,181 women with stage II or III breast cancer, aiming to determine if a telephone-based weight-loss intervention can reduce cancer recurrence risk by promoting a weight loss of at least 10%.

The intervention includes 42 sessions over 2 years focusing on increased physical activity and caloric restriction, with the potential to significantly improve cancer outcomes and influence future care for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Delahanty, LM., Wadden, TA., Goodwin, PJ., et al.[2023]

A 15-week clinic-based weight loss program for cancer survivors significantly improved health-related quality of life, enhancing physical functioning and reducing insomnia and sleep disturbances compared to a waitlist control group.

Participants in the weight loss program maintained their weight loss after 30 weeks, while those in the control group also lost weight after starting the program, indicating the intervention's effectiveness in promoting sustained weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Brown, JC., Giobbie-Hurder, A., Yung, RL., et al.[2023]

The ENERGY study is a 4-year clinical trial involving 693 overweight or obese women with early-stage breast cancer, aimed at demonstrating the feasibility of sustained weight loss and its impact on quality of life and co-morbidities.

The trial's intervention includes a cognitive-behavioral weight loss program, which could establish weight loss support as a new standard of care for breast cancer survivors, potentially improving their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. Rock, CL., Byers, TE., Colditz, GA., et al.[2021]

This systematic review analyzed 11 randomized controlled trials (RCTs) focused on theory-based lifestyle interventions for weight loss in breast cancer survivors, finding that 7 of these trials were classified as 'very promising' in their effectiveness to reduce body weight by at least 5%.

The most commonly used theoretical framework was Social Cognitive Theory, and all interventions included key behavioral change techniques such as goal setting and self-monitoring, which are crucial for successful weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Perperidi, M., Saliari, D., Christakis, C., et al.[2023]

Participants who followed a 12-month clustered campaign treatment schedule regained significantly less weight (0.35 kg) compared to those in a self-directed program (2.40 kg), indicating that structured support can help maintain weight loss after an initial treatment.

The clustered campaign approach allowed participants to maintain 87% of their weight loss, while those in the self-directed group maintained only 64%, highlighting the effectiveness of group-based support in preventing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Dutton, GR., Gowey, MA., Tan, F., et al.[2021]

A systematic review of 32 studies on weight loss interventions for overweight cancer survivors found that effective programs typically resulted in less than 5% weight loss and often did not assess long-term effects beyond 12 months.

Successful interventions combined dietary changes and physical activity, utilizing behavior change techniques like goal setting, action planning, and social support, highlighting the importance of structured support in achieving weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the optimal strategy for sustained weight loss in overweight cancer survivors: a systematic review of the literature. Hoedjes, M., van Stralen, MM., Joe, STA., et al.[2018]

An interdisciplinary comprehensive weight loss program, combined with a biweekly behavioral maintenance program, helped participants maintain 83% of their initial weight loss after 18 months.

This multi-disciplinary approach, which includes social support and aerobic exercise, is considered the best current treatment for obesity, providing significant long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment of obesity: a behavioral medicine perspective. Pera, V., Clark, MM., Abrams, DB.[2005]

References

1. Australia pubmed.ncbi.nlm.nih.gov

The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Relationship of psychiatric diagnosis and weight loss maintenance in obese breast cancer survivors. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Tele-Motivational Interviewing for Cancer Survivors: Feasibility, Preliminary Efficacy, and Lessons Learned. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Bariatric surgery in cancer survivorship: does a history of cancer affect weight loss outcomes? [2018]

6. England pubmed.ncbi.nlm.nih.gov

Weight loss intervention trials in women with breast cancer: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

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]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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]

11. England pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Toward the optimal strategy for sustained weight loss in overweight cancer survivors: a systematic review of the literature. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Current treatment of obesity: a behavioral medicine perspective. [2005]