Mobile Weight Loss Intervention for Cancer Survivors

(AYAConnect Trial)

Overseen By Molly Diamond, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must not be taking: Appetite suppressants

Disqualifiers: Type 1 diabetes, Heart attack, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can help young cancer survivors lose weight and maintain a healthier lifestyle. The app tracks weight, physical activity, and diet to support a behavioral weight loss program. Participants will receive one of three interventions using the app: the AYA Connect intervention (also known as the Mobile Weight Loss Intervention), the Positive Psychology Plus (PP+) intervention, or the Positive Psychology (PP) intervention. Suitable candidates have survived adolescent or young adult cancer, completed treatment at least six months ago, and have a BMI (a measure of body fat based on height and weight) between 25 and 50. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve health outcomes for young cancer survivors.

Will I have to stop taking my current medications?

The trial requires that you are not currently using prescription medications that affect appetite or weight. If you are taking such medications, you may need to stop them to participate.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using prescription medications that affect appetite or weight.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study tested the AYA Connect program, a mobile app for weight loss, on young cancer survivors. The results showed that the app was safe, with no major health issues reported. Participants found the app easy to use, and it effectively helped them manage their weight.

Research into Positive Psychology Plus (PP+) and Positive Psychology (PP) programs for cancer survivors also shows they are safe. These programs aim to increase positive feelings and reduce stress. Studies have shown that participants generally feel happier and less stressed, with no major negative side effects.

Overall, these programs are designed to be safe and easy to use, focusing on improving well-being through digital tools and positive thinking techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mobile weight loss interventions for adolescent and young adult cancer survivors because they offer a novel, integrated approach that combines digital accessibility with psychological support. Unlike traditional weight management programs that often focus solely on dietary and exercise guidelines, these interventions incorporate elements of positive psychology, which aim to enhance mental well-being alongside physical health. The AYA Connect intervention provides a tailored experience for young cancer survivors, while the addition of Positive Psychology (PP) and Positive Psychology Plus (PP+) interventions offer layers of support that can boost motivation and adherence. By addressing both the physical and emotional aspects of weight management, these interventions have the potential to improve overall quality of life for cancer survivors.

What evidence suggests that this trial's treatments could be effective for weight loss in cancer survivors?

Research has shown that the AYA Connect program, an intervention in this trial, may help young cancer survivors manage their weight. In earlier studies, participants improved their diet and reduced calorie intake, both crucial for weight loss. The Positive Psychology Plus (PP+) program, another intervention in this trial, greatly improved quality of life and overall well-being. Similarly, the Positive Psychology (PP) program, also part of this trial, may increase happiness and reduce depression. Together, these programs aim to enhance health and well-being for cancer survivors in a comprehensive manner. ^{3 5 6 7 8}

Who Is on the Research Team?

Carmina Valle, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for young adult cancer survivors who are dealing with weight issues. Participants should be interested in using a mobile app to help with weight loss and increasing physical activity.

Inclusion Criteria

I was diagnosed with my first invasive cancer between 15-39 years old.

I finished my main cancer treatment 6 months ago but may be on maintenance therapy.

Body Mass Index (BMI) of 25-50 kg/m2

Exclusion Criteria

I cannot walk for exercise due to health issues.

Inability to speak and read English

No Internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 3-month mobile weight loss intervention using a smartphone app, with variations including AYA Connect, AYA Connect-PP, and AYA Connect-PP+

3 months

Weekly virtual sessions for AYA Connect-PP+ group

Maintenance

A 3-month maintenance phase with no contact, focusing on self-monitoring and adherence to the intervention

3 months

Follow-up

Participants are monitored for retention, adherence, and changes in health metrics post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AYA Connect intervention
• Positive Psychology Plus (PP+) intervention
• Positive Psychology (PP) intervention

Trial Overview The study tests three interventions: AYA Connect, Positive Psychology (PP), and Positive Psychology Plus (PP+). All use a smartphone app integrating diet monitoring and activity tracking to support weight loss.

How Is the Trial Designed?

Group I: AYA Connect-PP+ Experimental Treatment 3 Interventions

Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.

Group II: AYA Connect-PP Experimental Treatment 2 Interventions

Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.

Group III: AYA Connect Experimental Treatment 1 Intervention

Adolescent and young adult cancer survivors receive AYA Connect intervention.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

A study involving 123 overweight cancer survivors is investigating the effectiveness of a personalized mobile health (mHealth) self-management program aimed at improving physical and psychological health outcomes over 12 weeks.

Participants in the intervention group received tailored lifestyle support from healthcare professionals and engaged in goal-setting for physical activity, with the study's results expected to provide insights into the acceptability and efficacy of mHealth interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Impact of a Personalized Self-Management Lifestyle Program Using Mobile Technology on the Health and Well-Being of Cancer Survivors: Protocol and Rationale for a Randomized Controlled Trial (The Moving On Study). Groarke, JM., Richmond, J., Kelly, MG., et al.[2020]

A group-based weight control intervention delivered via conference calls led to an average weight loss of 12.5 kg (13.9% of baseline weight) among obese breast cancer survivors in rural areas, demonstrating its efficacy in this population.

Participants also showed significant improvements in waist circumference, dietary habits, physical activity levels, and quality of life, including mood and body image, indicating that the intervention positively impacted both health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a weight loss intervention among rural breast cancer survivors. Befort, CA., Klemp, JR., Austin, HL., 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]

Psychological factors such as internal motivation, self-monitoring, and positive emotions are crucial for maintaining weight loss, and these can be addressed through clinical interventions based on Pender's health promotion model.

Nurse practitioners can play a key role in supporting patients' weight loss maintenance by conducting regular psychological needs assessments, which may enhance long-term success in weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological factors associated with weight loss maintenance: theory-driven practice for nurse practitioners. Valek, RM., Greenwald, BJ., Lewis, CC.[2015]

A randomized controlled trial (NCT04132219) is testing a web-based lifestyle intervention called DUET for 56 dyads of cancer survivors and their partners, focusing on improving diet, physical activity, and obesity over six months.

The study shows that web-based interventions are accessible and appealing to cancer survivors, but a significant number (42%) of interested survivors had difficulty finding a support partner, indicating a need for alternative strategies to enhance participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Pekmezi, DW., Crane, TE., Oster, RA., et al.[2022]

The Recapture Life program, a six-session online cognitive-behavioral intervention for adolescent and young adult cancer survivors, was found to be acceptable and feasible, with 75% of participants attending at least 5 out of 6 sessions and reporting high benefits from participation.

Despite some participants experiencing clinically concerning distress, none showed acute mental health risks, indicating that the program is safe for AYAs in the early post-treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and safety of the Recapture Life videoconferencing intervention for adolescent and young adult cancer survivors. Sansom-Daly, UM., Wakefield, CE., Bryant, RA., et al.[2020]

The EMPOWER intervention, a 5-week Web-based program designed for adolescent and young adult cancer survivors, focuses on enhancing psychological well-being through eight specific skills, such as gratitude and mindfulness.

Initial pilot testing has shown promise in terms of feasibility and acceptability, suggesting that if successful, EMPOWER could lead to a larger study to further evaluate its effectiveness in reducing psychological distress among AYAs who lack access to supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial. Salsman, JM., McLouth, LE., Cohn, M., et al.[2020]

Recent systematic reviews have identified six new randomized trials focusing on weight loss interventions in breast cancer survivors, indicating that these interventions, especially telephone-based ones, are feasible and effective for achieving weight loss.

Ongoing trials are set to assess the impact of weight loss on cancer outcomes, particularly in breast cancer, suggesting that longer-term interventions may be necessary to maintain weight loss and potentially improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Randomized Intervention Trials in Female Cancer Survivors. Chlebowski, RT., Reeves, MM.[2019]

A systematic review of 28 clinical trials involving technology-assisted interventions for childhood and adolescent/young adult (AYA) cancer survivors showed a significant overall treatment effect (g = 0.382), indicating these interventions can positively impact psychosocial outcomes.

The most effective interventions were distraction-based and focused on psychosocial and emotional health, while those aimed at improving cancer knowledge and physical health showed no significant benefits, highlighting the need for tailored approaches based on the specific challenges faced by different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Assisted Psychosocial Interventions for Childhood, Adolescent, and Young Adult Cancer Survivors: A Systematic Review and Meta-Analysis. Zhang, A., Zebrack, B., Acquati, C., et al.[2023]

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]

Digital health interventions are increasingly being recognized as effective tools to address the unique psychosocial needs of adolescents and young adults (AYA) with cancer, helping to improve their participation in behavioral health support.

Most studies currently focus on the feasibility and acceptability of these interventions rather than their efficacy, suggesting a need for more rigorous randomized controlled trials and diverse methodologies to fully assess their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for adolescent and young adult cancer survivors. Viola, A., Panigrahi, G., Devine, KA.[2021]

A systematic review of 27 studies found that broad-reach modalities, especially telephone-based interventions, effectively initiate behavior changes in cancer survivors regarding physical activity and diet.

While many studies showed positive results for starting lifestyle changes, only a few addressed long-term maintenance and cost-effectiveness, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone, print, and Web-based interventions for physical activity, diet, and weight control among cancer survivors: a systematic review. Goode, AD., Lawler, SP., Brakenridge, CL., et al.[2022]

A Survivor's Journey is a web-based psychosocial intervention developed specifically for adolescent and young adult survivors of pediatric brain tumors, based on feedback from focus groups and clinical providers, highlighting the need for customizable support.

The intervention consists of five core sessions and up to seven supplemental sessions, addressing common concerns like memory and mood, and aims to improve psychosocial functioning while being accessible and cost-effective for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Psychosocial Intervention for Adolescent and Young Adult Survivors of Pediatric Brain Tumor. Raj, SP., Narad, ME., Salloum, R., et al.[2019]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05088

A Mobile Weight Loss Intervention (AYA Connect) for ... This clinical trial evaluates a mobile weight loss intervention (AYA Connect) for weight management among adolescent and young adult (AYA) cancer survivors.

2. reporter.nih.gov reporter.nih.gov/search/JbRgAtchAUKHOoW2X1vObQ/project-details/11062439

Project Details - NIH RePORTER We hypothesize that compared to the self-guided arm, AYAs in the intervention arm will manifest greater percent weight loss at 6 months and better maintenance ...

3. npcf.us npcf.us/clinical-trials/mobile-weight-loss-intervention-for-adolescent-and-young-adult-cancer-survivors/

Mobile Weight Loss Intervention For Adolescent And ... The 3-month interventions are aimed at promoting improvements in diet quality consistent with recommendations for cancer survivors, a decrease in energy intake, ...

4. bmcdigitalhealth.biomedcentral.com bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00064-1

a randomized controlled pilot trial | BMC Digital Health This trial was conducted in three AYA cancer survivor clinics to determine feasibility of the intervention and examine preliminary effectiveness ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06171945/mobile-weight-loss-intervention-for-adolescent-and-young-adult-cancer-survivors?state=NC&city=Chapel%20HIll

Mobile Weight Loss Intervention for Adolescent and Young ... The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06848491

Study Details | NCT06848491 | Using Tailored mHealth ... AYA WELL is a multi-site randomized clinical trial to test the efficacy of a 6-month theory-based, mHealth weight management intervention designed specifically ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090968/

Interventions about physical activity and diet and their ... This systematic review aims to evaluate the effectiveness of PA and diet interventions for AYA cancer survivors and to critically evaluate existing literature, ...

8. trials.teamjackfoundation.org trials.teamjackfoundation.org/trials/NCT06171945

Mobile Weight Loss Intervention for Adolescent and Young Adult ... The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss ...