Pediatric Cancer SurvivorNCT06763770
Digital Self-Management and Peer Mentoring Intervention
A study testing Managing Your Health (MYH) in people with Pediatric Cancer Survivor and Survivorship, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Pediatric Cancer Survivor, Survivorship, Cancer
- What is being tested?
- Managing Your Health (MYH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis with any malignant childhood cancer between the ages 0-19 at least 5 years prior
- Cancer treatment occurred at a pediatric center/facility
- Current age 18-25
- At least 2 years from treatment completion (typical time for transfer to long-term follow-up care)
Who cannot join
- Any documented physical or self-reported cognitive delay that could prevent self-management of health care
- Diagnoses of cancer not typically considered pediatric (I.e., melanoma, carcinoma of the breast, colorectum, lung, ovary, and testicle)
- Unable to speak/read English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of South California
Los Angeles, California, 900339239
Rutgers Cancer Institute
New Brunswick, New Jersey, 089011914
About this study
Official title: Digital Self-Management and Peer Mentoring Intervention to Improve the Transition From Pediatric to Adult Health Care for Childhood Cancer Survivors
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.
Read the detailed description
The purpose of the study is to determine the efficacy of the Managing Your Health intervention to improve self-management of survivorship care among young adult survivors of childhood cancer.
Aim 1: Evaluate the efficacy of the Managing Your Health intervention. Aim 2: Determine the mechanisms through which Managing Your Health influences outcomes.
Aim 3: Identify subgroups of participants for which treatment effects vary to inform future scale up.
Managing Your Health will be tested in a two-arm parallel randomized controlled trial (RCT) of the intervention versus usual care + educational control with 300 young adult survivors of childhood cancer currently aged 18-25 years. Participants will complete outcome measures at baseline, 3 months, and 12 months post-randomization.
- Conditions
- Pediatric Cancer Survivor, Survivorship, Cancer
- Being tested
- Managing Your Health (MYH), The Usual Care + Educational Control
- Keywords
- Pediatric cancer survivors, Self-management, Young adults, Childhood cancer survivors, Transition, Peer mentor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Your Health (MYH)Behavioural
The Managing Your Health intervention consists of six weekly videoconference calls with a peer mentor and five self-management educational modules within a mobile application. The first call is to get to know each other, share survivorship stories, identify self-management strengths and weaknesses, and select goals for participation in the intervention. The remaining five weekly calls cover a self-management topic each week, including understanding your survivorship care plan, navigating the healthcare system and insurance, managing the emotional aspects of survivorship, negotiating family and significant other involvement in care, and engaging in healthy lifestyle behaviors.
The Usual Care + Educational ControlBehavioural
The Usual Care + Educational Control group will receive weekly emails with links to the Health Links developed by the Children's Oncology Group for use in survivorship care. Access to these Health Links reflects the current state of clinical care available to survivors. These Health Links were developed as patient education materials to cover relevant self-management and survivorship care topics. The weekly messages will align with the content of the modules from Managing Your Health to provide similar information, including Introduction to Long-Term Follow-Up (Module 1), Finding and Paying for Healthcare (Module 2), Emotional Issues (Modules 3 and 4), Educational Issues, Diet and Physical Activity, Skin Health, Reducing the Risk of Second Cancers, and Male/Female Health Issues (Module 5).
| Study group | Role | What they receive |
|---|---|---|
| Managing Your Health (MYH) | Experimental | The Managing Your Health app + Peer Mentoring Intervention Receives: Behavioral: Managing Your Health (MYH) |
| Usual Care + Educational Control | Active comparator | The Usual Care + Educational Control Receives: Behavioral: The Usual Care + Educational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Management behaviors
The Self-Management Skills scale is a 15-item measure about a patient's active behaviors in managing their health. Response options were modified such that participants respond on a 5-point scale from 1 (not at all) to 5 (completely) regarding their agreement to each item. Example items include "I participate in making decisions about my health" and "I book my own doctor's appointments." A total mean score will be used, which could range from 0 to 5. Higher scores indicate better self-management behaviors.
Measured: Baseline, 3 months, 12 months
Secondary outcomes (2)
Adherence to guideline-concordant survivorship care
Participants will report on cancer-specific and general medical appointments, surveillance tests, cancer screenings, and detection of new comorbidities using items from the Follow-Up Care Use Among Survivors (FOCUS) survey developed by NCI and items from surveys in the Childhood Cancer Survivor Study. Given the purposeful heterogeneity of our sample, we focus on the most common surveillance recommendations. We will report separately on receipt of cancer-related follow-up care (yes/no) and survivorship care plan (yes/no). For other tests, participants will be deemed adherent if they are up-to-date on recommended tests based on their health history. A summary score will be calculated for each participant by dividing the total number of recommendations completed by the total number of guideline-recommended tests. Thus, each participant will have a score that could range from 0 to 1, with 0 indicating no engagement in care and 1 indicating fully adherent to guideline concordant care.
Measured: Baseline, 12 months
Health-related Quality of Life
The Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure is a 10-item measure that assesses self-rated health, physical quality of life, mental quality of life, fatigue, pain, and participation in social activities and roles. The PROMIS measures have undergone extensive testing and are widely used. The Global Health measure yields a Physical Summary and Mental Health Summary scores, in addition to the total score. We will use the total score, which is standardized as a T-score with a mean of 50 and standard deviation of 10.
Measured: Baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start4 Mar 2025
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Southern California, Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Katie Devine, PhD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Kristine Levonyan-Radloff, MS, Study director, Rutgers Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763770
- Sponsor's protocol ID
- Pro2023000838
- Other IDs
- R01CA282147
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will collect self-reported and medical-record data from 300 AYA survivors of childhood cancer. The final dataset will include self-reported demographic, psychosocial, and behavioral data from surveys as well as records of healthcare utilization. Documentation of the variables included in the dataset will be provided with the dataset.
Publications
Collins MKR, Levonyan-Radloff K, McLaughlin J, Masterson M, Devine KA. Designing an App to Facilitate Self-Management in Young Adult Survivors of Childhood Cancer: Development and Usability Study. JMIR Cancer. 2025 Dec 24;11:e77121. doi: 10.2196/77121.
PubMed 41442700
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Self-Management and Peer Mentoring Intervention to Improve the Transition From Pediatric to Adult Health Care for Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT06763770
- Acronym / sponsor ID
- Pro2023000838
- Conditions
- Pediatric Cancer Survivor, Survivorship, Cancer
- Keywords
- Pediatric cancer survivors, Self-management, Young adults, Childhood cancer survivors, Transition, Peer mentor
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Southern California, Children's Hospital Los Angeles
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to determine the efficacy of the Managing Your Health intervention to improve self-management of survivorship care among young adult survivors of childhood cancer.
Aim 1: Evaluate the efficacy of the Managing Your Health intervention. Aim 2: Determine the mechanisms through which Managing Your Health influences outcomes.
Aim 3: Identify subgroups of participants for which treatment effects vary to inform future scale up.
Managing Your Health will be tested in a two-arm parallel randomized controlled trial (RCT) of the intervention versus usual care + educational control with 300 young adult survivors of childhood cancer currently aged 18-25 years. Participants will complete outcome measures at baseline, 3 months, and 12 months post-randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managing Your Health (MYH) | Experimental | Behavioral: Managing Your Health (MYH)The Managing Your Health app + Peer Mentoring Intervention |
| Usual Care + Educational Control | Active comparator | Behavioral: The Usual Care + Educational ControlThe Usual Care + Educational Control |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis with any malignant childhood cancer between the ages 0-19 at least 5 years prior
- Cancer treatment occurred at a pediatric center/facility
- Current age 18-25
- At least 2 years from treatment completion (typical time for transfer to long-term follow-up care)
Key exclusion criteria (3 listed)
- Any documented physical or self-reported cognitive delay that could prevent self-management of health care
- Diagnoses of cancer not typically considered pediatric (I.e., melanoma, carcinoma of the breast, colorectum, lung, ovary, and testicle)
- Unable to speak/read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Managing Your Health (MYH)The Managing Your Health intervention consists of six weekly videoconference calls with a peer mentor and five self-management educational modules within a mobile application. The first call is to get to know each other, share survivorship stories, identify self-management strengths and weaknesses, and select goals for participation in the intervention. The remaining five weekly calls cover a self-management topic each week, including understanding your survivorship care plan, navigating the healthcare system and insurance, managing the emotional aspects of survivorship, negotiating family and significant other involvement in care, and engaging in healthy lifestyle behaviors. | Behavioural | Managing Your Health (MYH) |
| The Usual Care + Educational ControlThe Usual Care + Educational Control group will receive weekly emails with links to the Health Links developed by the Children's Oncology Group for use in survivorship care. Access to these Health Links reflects the current state of clinical care available to survivors. These Health Links were developed as patient education materials to cover relevant self-management and survivorship care topics. The weekly messages will align with the content of the modules from Managing Your Health to provide similar information, including Introduction to Long-Term Follow-Up (Module 1), Finding and Paying for Healthcare (Module 2), Emotional Issues (Modules 3 and 4), Educational Issues, Diet and Physical Activity, Skin Health, Reducing the Risk of Second Cancers, and Male/Female Health Issues (Module 5). | Behavioural | Usual Care + Educational Control |
Primary outcome
Self-Management behaviors
Time frame: Baseline, 3 months, 12 months
The Self-Management Skills scale is a 15-item measure about a patient's active behaviors in managing their health. Response options were modified such that participants respond on a 5-point scale from 1 (not at all) to 5 (completely) regarding their agreement to each item. Example items include "I participate in making decisions about my health" and "I book my own doctor's appointments." A total mean score will be used, which could range from 0 to 5. Higher scores indicate better self-management behaviors.
2 secondary outcomes
Adherence to guideline-concordant survivorship care
Time frame: Baseline, 12 months
Health-related Quality of Life
Time frame: Baseline, 3 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41442700Collins MKR, Levonyan-Radloff K, McLaughlin J, Masterson M, Devine KA. Designing an App to Facilitate Self-Management in Young Adult Survivors of Childhood Cancer: Development and Usability Study. JMIR Cancer. 2025 Dec 24;11:e77121. doi: 10.2196/77121.
- Individual participant dataSharing planned: Yes. The proposed research will collect self-reported and medical-record data from 300 AYA survivors of childhood cancer. The final dataset will include self-reported demographic, psychosocial, and behavioral data from surveys as well as records of healthcare utilization. Documentation of the variables included in the dataset will be provided with the dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristine Levonyan-Radloff, MS study director
Rutgers Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Your Health (MYH) in people with Pediatric Cancer Survivor and Survivorship, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Management behaviors (time frame: Baseline, 3 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.