Digital Self-Management for Childhood Cancer Survivors

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Cognitive delay, Non-pediatric cancer, others

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

Compensation: Varies

Number of Visits: 15

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving self-management skills for young adult survivors of childhood cancer.

What data supports the effectiveness of the treatment Managing Your Health (MYH) for childhood cancer survivors?

Research shows that self-management education programs can improve self-efficacy (confidence in managing one's health), health knowledge, and health behaviors in people with chronic diseases. Digital tools, like mobile health apps, are seen as promising ways to deliver these programs to childhood cancer survivors, potentially enhancing their care. ^{1 2 3 4 5}

Is the digital self-management program safe for childhood cancer survivors?

The available research does not provide specific safety data for the digital self-management program, but digital health interventions are generally considered feasible and acceptable for pediatric cancer survivors. ^{2 3 5 6 7}

How is the treatment Managing Your Health (MYH) different from other treatments for childhood cancer survivors?

Managing Your Health (MYH) is unique because it uses digital self-management tools, like mobile health (mHealth) apps, to help childhood cancer survivors manage their health. This approach is novel as it leverages technology to deliver self-management education, which is not commonly used in existing treatments for this population. ^{2 3 5 6 8}

What is the purpose of this trial?

This study tests how helpful a digital self-management and peer mentoring program is to young adult survivors of childhood cancer to improve their ability to manage their survivorship care as they transition from pediatric to adult-oriented follow-up care. Survivors require lifelong "risk-based" follow-up care based on the treatment they received to identify and treat late health effects. The transition from pediatric to adult follow-up care is a critical period when many survivors are lost to follow-up. Barriers to successful transition and engagement in care include poor knowledge of cancer history, low healthcare self-efficacy, poor self-management skills, low health literacy, and access issues such as financial hardship, insurance, and distance from cancer center. The "Managing Your Health" digital self-management and peer mentoring program aims to address these gaps and improve survivorship care self-management. Improvements in healthcare self-management are necessary to keep young adult survivors engaged in recommended health care, improve their quality of life, and promote optimal health.

Research Team

Kristine Levonyan-Radloff, MS

Principal Investigator

Rutgers Cancer Institute

Eligibility Criteria

This trial is for young adult survivors of childhood cancer who are transitioning from pediatric to adult follow-up care. They should be in need of support to manage their survivorship care and overcome barriers such as poor knowledge, low self-efficacy, and access issues.

Inclusion Criteria

I was diagnosed with cancer as a child or teenager, at least 5 years ago.

My cancer treatment was at a children's hospital.

At least 2 years from treatment completion (typical time for transfer to long-term follow-up care)

Exclusion Criteria

I have a condition that makes it hard for me to manage my health care on my own.

My cancer type is usually not found in children.

Unable to speak/read English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Managing Your Health app and Peer Mentoring Intervention or receive Usual Care + Educational Control

3 months

Baseline, 3 months

Follow-up

Participants are monitored for self-management behaviors, health-related quality of life, and adherence to guideline-concordant survivorship care

9 months

12 months

Treatment Details

Interventions

• Managing Your Health (MYH)

Trial Overview The study evaluates a digital program called 'Managing Your Health' combined with peer mentoring versus usual care plus education. It aims to improve the participants' ability to manage their health after surviving cancer during childhood.

Participant Groups

Group I: Managing Your Health (MYH) Experimental Treatment 1 Intervention

The Managing Your Health app + Peer Mentoring Intervention

Group II: Usual Care + Educational Control Active Control 1 Intervention

The Usual Care + Educational Control

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Findings from Research

The LETSGO model, which involves nurse-led consultations and eHealth technology, was well-received by patients, who felt safer and more empowered in managing their health after cancer treatment.

Participants reported increased confidence in recognizing cancer recurrence symptoms and were motivated to enhance their physical activity, although some faced technical issues with the app that need to be addressed before wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer. Skorstad, M., Vistad, I., Fegran, L., et al.[2022]

A systematic review of eight studies on digital self-management interventions for childhood cancer survivors found that these interventions did not significantly improve health-related quality of life or moderate-to-vigorous physical activity, indicating limited effectiveness.

While the interventions showed a trend towards increasing physical activity over time, the results were not statistically significant, highlighting the need for better-designed studies to assess their true impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. Hong, HC., Min, A., Kim, YM.[2021]

In a pilot study involving 26 female childhood cancer survivors, the Health Storylines mHealth app was used frequently, with some participants accessing it up to 902 times, but overall, there were no statistically significant improvements in self-efficacy, perceived illness, or health-related quality of life after 3 or 6 months of use.

The study highlighted that while the app's mental health component was utilized by all participants, the effectiveness varied significantly between high and low users, suggesting that further research is needed to identify which individuals benefit most from such mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness. Cantrell, MA., Ruble, K., Mensinger, J., et al.[2022]

Self-management education programs (SMEPs) can significantly improve self-efficacy, health knowledge, and health behaviors in chronic disease populations, but very few are tailored for adolescent and young adult (AYA) survivors of childhood cancer, who face unique health risks and challenges.

Mobile health (mHealth) applications are identified as a promising method for delivering self-management education to AYA cancer survivors, but these interventions need thorough evaluation to ensure they effectively support survivor-focused care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Literature Review and Environmental Scan of Self-management Education Programs for Adolescent and Young Adult Survivors of Childhood Cancer. Kobe, CM., Turcotte, LM., Sadak, KT.[2023]

Digital health interventions are generally well-received by pediatric cancer survivors, providing benefits such as self-awareness, social connection, and empowerment, based on a systematic review of 16 qualitative studies.

However, users also face challenges related to program content, technology, and personal usage, highlighting the need for tailored interventions to enhance their effectiveness and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. Cheng, L., Liu, F., Mao, X., et al.[2022]

About 23.7% of young adult cancer survivors and their parents registered for the ePHR, Cancer SurvivorLinkTM, and 38% of those registrants used it meaningfully, indicating a significant but selective engagement with the tool.

Young adult survivors transitioning to adult care were more likely to use the ePHR meaningfully, and using SurvivorLink was linked to a higher likelihood of attending annual follow-up visits, suggesting it may enhance care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaningful Use of an Electronic Personal Health Record (ePHR) among Pediatric Cancer Survivors. Williamson, RS., Cherven, BO., Gilleland Marchak, J., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. [2021]

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

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness. [2022]

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

Mixed methods assessment of impact on health awareness in adult childhood cancer survivors after viewing their personalized digital treatment summary and follow-up recommendations. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A Narrative Literature Review and Environmental Scan of Self-management Education Programs for Adolescent and Young Adult Survivors of Childhood Cancer. [2023]

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

The Pediatric Cancer Survivors' User Experiences With Digital Health Interventions: A Systematic Review of Qualitative Data. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Meaningful Use of an Electronic Personal Health Record (ePHR) among Pediatric Cancer Survivors. [2018]

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

Acceptability and feasibility of survivorship care plans and an accompanying mobile health intervention for adolescent and young adult survivors of childhood cancer. [2022]