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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.

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.

What data supports the effectiveness of the Mobile Weight Loss Intervention for Cancer Survivors treatment?

Research shows that weight loss interventions, especially those using telephone-based methods, are feasible and effective in helping female cancer survivors lose weight. Psychological factors like positive mood and self-monitoring also play a crucial role in maintaining weight loss, which is important for cancer survivors. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment AYA Connect intervention for weight loss in cancer survivors?

Research shows that weight loss interventions, especially those using telephone-based methods, are feasible and effective in helping female cancer survivors lose weight. Psychological factors like positive mood and self-monitoring also play a crucial role in maintaining weight loss, which is important for cancer survivors. ^{1 2 3 4 5}

Is the Mobile Weight Loss Intervention for Cancer Survivors safe for humans?

The research articles reviewed do not provide specific safety data for the Mobile Weight Loss Intervention or its related interventions. However, they suggest that technology-assisted interventions for cancer survivors, in general, are considered feasible and acceptable, implying a level of safety in their use. ^{6 7 8 9 10}

Is the Mobile Weight Loss Intervention for Cancer Survivors safe for humans?

The research on technology-assisted interventions for adolescent and young adult cancer survivors, including online psychological therapies, suggests they are generally safe and provide evidence-based support. ^{6 7 8 9 10}

How is the Mobile Weight Loss Intervention for Cancer Survivors different from other treatments?

The Mobile Weight Loss Intervention for Cancer Survivors is unique because it uses mobile technology to deliver a personalized self-management lifestyle program, focusing on weight loss and positive psychology to improve both physical and psychological outcomes for cancer survivors. This approach is particularly novel as it combines technology-assisted interventions with positive psychology, which is not commonly used in traditional cancer survivor treatments. ^{7 8 11 12 13}

How is the Mobile Weight Loss Intervention for Cancer Survivors different from other treatments?

The Mobile Weight Loss Intervention for Cancer Survivors is unique because it uses mobile technology to deliver a personalized self-management lifestyle program, focusing on weight loss and positive psychology to improve both physical and psychological outcomes for cancer survivors, particularly targeting the tech-savvy adolescent and young adult population. ^{7 8 11 12 13}

Research Team

Carmina Valle, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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.

I am between 18 and 39 years old.

Exclusion Criteria

I cannot walk for exercise due to health issues.

Inability to speak and read English

No Internet access

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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 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]

References

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

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

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

Weight Loss Randomized Intervention Trials in Female Cancer Survivors. [2019]

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

Psychological factors associated with weight loss maintenance: theory-driven practice for nurse practitioners. [2015]

4. 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]

5. Switzerland 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. [2022]

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

Digital interventions for adolescent and young adult cancer survivors. [2021]

7. Canada 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. [2020]

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

Technology-Assisted Psychosocial Interventions for Childhood, Adolescent, and Young Adult Cancer Survivors: A Systematic Review and Meta-Analysis. [2023]

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

Development of a Web-Based Psychosocial Intervention for Adolescent and Young Adult Survivors of Pediatric Brain Tumor. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and safety of the Recapture Life videoconferencing intervention for adolescent and young adult cancer survivors. [2020]

11. Canada 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). [2020]

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

Telephone, print, and Web-based interventions for physical activity, diet, and weight control among cancer survivors: a systematic review. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of a weight loss intervention among rural breast cancer survivors. [2021]