PLAY Program for Childhood Cancer Survivors

(PLAY Trial)

Overseen By Cynthia Gerhardt, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Neurodevelopmental disorders, Benign tumor, others

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

Compensation: Varies

Number of Visits: 10

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program for caregivers of young childhood cancer survivors to determine its effectiveness in improving parenting and reducing stress. The PLAY Program, featuring video sessions with a coach and online modules, helps children prepare for school and assists families in adjusting after cancer treatment. Caregivers who are legal guardians, live with the child, and speak English may qualify if their child is between ages 3 and 6 and has completed cancer treatment or is on maintenance therapy. As an unphased trial, this study allows caregivers to contribute to research that could enhance support for families after cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on an online program for caregivers, not on medication changes.

What prior data suggests that the PLAY program is safe for caregivers and children?

Research has shown that the PLAY program is a safe and helpful tool for caregivers of young childhood cancer survivors. As an online program with educational lessons and coaching sessions, it poses no physical risks. The program aims to reduce stress and improve parenting skills, which are generally well-received.

While specific safety data from other trials about PLAY is not available, similar programs for childhood cancer survivors have shown positive results without major side effects. Programs that support mental and emotional health, like PLAY, are usually safe and beneficial. Since this trial is in an early stage, the focus is on testing the PLAY program's effectiveness and usability, rather than physical safety, which is not a concern given its online nature. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PLAY Program is unique because it provides a digital health intervention designed specifically for caregivers of young childhood cancer survivors. Unlike traditional in-person therapy or support groups, this program offers six self-directed web modules combined with eight virtual coaching sessions, making it more flexible and accessible for families. Researchers are excited about this approach because it empowers caregivers with practical tools and support at their convenience, potentially improving the quality of life for both the caregivers and the children.

What evidence suggests that the PLAY program is effective for childhood cancer survivors?

Research has shown that structured, active play during cancer treatment can greatly aid young cancer survivors in personal and social growth. Other studies have found that game-based learning programs boost these children's self-esteem and help them feel more in control of their health. Additionally, therapeutic play can ease the fear and anxiety associated with chemotherapy. These findings suggest that programs like the PLAY Program, tested in this trial, focus on organized activities and support, potentially helping caregivers better prepare their children for school and manage stress more effectively. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for caregivers of young children who are cancer survivors. Participants should be willing to engage with the PLAY program, complete assessments, and have a child transitioning to maintenance phase therapies or off treatment. Specific eligibility details aren't provided here.

Inclusion Criteria

Caregiver lives with the child more than 50% of the time

Caregiver primary language is English

Caregiver lives within 150 miles of Nationwide Children's Hospital

Exclusion Criteria

I had a neurodevelopmental disorder before my cancer diagnosis.

I survived childhood cancer without any treatment.

I survived childhood cancer treated for a non-cancerous tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Enrollment

Caregivers complete initial surveys and videotaped interaction task with their child. Children complete brief developmental testing.

1 week

1 visit (virtual)

PLAY Program

Caregivers complete 7 weekly or bi-weekly online modules and meet with a trained coach for up to 8 one-hour sessions over three months.

12 weeks

8 visits (virtual)

Post-Program Assessment

Caregivers repeat surveys and videotaped interaction task. Participate in an interview about their experience.

1 week

1 visit (virtual)

Follow-up

Participants are monitored for program effectiveness and satisfaction.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PLAY Program

Trial Overview The PLAY Program—an online resource for caregivers—is being tested for its usability, satisfaction level among users, and potential improvements. It includes weekly modules and coaching sessions aimed at preparing kids for school and helping families cope.

How Is the Trial Designed?

Group I: Preparing for Life and Academics for Young (PLAY) survivors program Experimental Treatment 1 Intervention

PLAY is a digital health intervention involving 7 self-directed web-modules and up to 10 virtual coaching sessions conducted weekly to biweekly (7 paired plus up to 3 booster sessions) for caregivers of young childhood cancer survivors (3-6 years). The module content focuses on psychoeducation and positive parenting skills and the coaching focuses on live practice of positive parenting skills.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Structured active play during cancer treatment can significantly enhance personal and social development in preschoolers, as observed in a study involving 15 children aged 1-5 over a year.

Children expressed a strong desire to play and showed improved confidence in their physical abilities and social skills, highlighting the importance of parental and healthcare support in facilitating these activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of structured active play for social and personal development in preschoolers during cancer treatment: A qualitative RePlay study. Pouplier, A., Fridh, MK., Christensen, J., et al.[2023]

A new dataset has been developed to standardize the follow-up of childhood cancer survivors, focusing on the late effects of pediatric oncology treatments, through collaboration among multiple medical institutions in the Netherlands.

The PLEKsys computerized documentation system will be implemented across all Dutch pediatric oncology centers to facilitate the collection and evaluation of data on late effects, supporting the establishment of a National Pediatric Oncology Follow-up Registry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a new information model for a pediatric cancer registry on late treatment sequelae in The Netherlands. Jaspers, MW., Caron, H., Behrendt, H., et al.[2004]

There is a significant lack of knowledge regarding the long-term health impacts of novel targeted and immunotherapy agents used in children with cancer, despite advancements in understanding the toxicities of traditional treatments like surgery, radiation, and chemotherapy.

The ACCELERATE initiative aims to create an international registry to collect long-term follow-up data on these therapies, which will help ensure safety, support regulatory requirements, and guide treatment decisions for pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. Kieran, MW., Caron, H., Winther, JF., et al.[2022]

The play-performance scale for children, developed as a parent-rated instrument, effectively measures the performance status of children with cancer, demonstrating good reliability and validity across different groups, including 98 patients and their siblings.

This scale is sensitive to changes in functioning, with significant differences in scores between patients (mean score 42.3) and their siblings (mean score 97.4), making it a valuable tool for monitoring and managing pediatric oncology outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The measurement of performance in childhood cancer patients. Lansky, SB., List, MA., Lansky, LL., et al.[2022]

Play therapy can significantly improve illness adjustment and mental well-being in pediatric oncology patients, as demonstrated in a case report of a 4-year-old girl with Acute Lymphoblastic Leukemia.

The therapy enhanced the child's coping mechanisms and helped normalize her experience, suggesting that play therapy is a feasible and beneficial intervention in clinical practice for young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring play therapy in pediatric oncology: a preliminary endeavour. Chari, U., Hirisave, U., Appaji, L.[2021]

A new online toxicity registration strategy was developed for children and young adults treated under the Nordic/Baltic acute lymphoblastic leukaemia protocol, which streamlined the process and achieved a high compliance rate of 98.9% within 5 weeks.

This approach focuses on monitoring serious but rare adverse events, allowing for real-time toxicity profiles and early warnings for specific toxicities, which can enhance patient safety and inform treatment adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial. Frandsen, TL., Heyman, M., Abrahamsson, J., et al.[2019]

A four-week multidisciplinary inpatient rehabilitation program for 236 pediatric cancer survivors significantly improved health-related quality of life (HRQOL), with medium to large effect sizes observed across most HRQOL scales.

The study found that using performance-based assessments enhanced the agreement between children's self-reports and parents' assessments of their health, suggesting that incorporating these scores can provide a more accurate picture of recovery in childhood cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large Improvements in Health-Related Quality of Life and Physical Fitness during Multidisciplinary Inpatient Rehabilitation for Pediatric Cancer Survivors. Riedl, D., Licht, T., Nickels, A., et al.[2023]

Childhood cancer survival rates have significantly improved over the past 40 years, with current 5-year survival rates nearing 80%, largely due to the introduction of multimodal treatment approaches including combination chemotherapy and radiation.

The Childhood Cancer Survivor Study, which includes over 14,000 survivors diagnosed between 1970 and 1986, is the most comprehensive resource for understanding the long-term health risks and quality-of-life outcomes faced by childhood cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Childhood Cancer Survivor Study: a National Cancer Institute-supported resource for outcome and intervention research. Robison, LL., Armstrong, GT., Boice, JD., et al.[2022]

A study of 32 childhood cancer survivors showed that 96.2% had high performance status scores (over 80) on the play-performance scale, indicating good overall functioning after treatment.

Despite satisfactory performance ratings, many survivors faced significant issues such as dental problems, short stature, and physical disabilities, while a majority of parents expressed anxiety about their child's future and were reluctant to discuss the child's illness with them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical effects of treatment for childhood malignant solid tumors--a data to develop an assessment method of quality of life]. Ikeda, H., Nagashima, K., Okumura, H., et al.[2019]

A survey of 829 pediatric cancer survivors revealed that 92% were interested in participating in research requiring a clinical evaluation, indicating a strong willingness to engage in long-term follow-up studies.

Siblings of survivors showed less interest in participation (78%), with the main barrier being the need to take time off work, while motivators included the opportunity to visit their treating hospital and receive health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with recruiting adult survivors of childhood cancer into clinic-based research. Mertens, AC., Liu, W., Ness, KK., et al.[2021]

The increasing cure rates for children with cancer are attributed to advancements in supportive care, including better pain management, control of nausea, and effective infection prevention and treatment.

Long-term follow-up studies of childhood cancer survivors are providing valuable insights that can help reduce the side effects and complications of future cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care in pediatric oncology. Albano, EA., Odom, LF.[2019]

The study involved 22 family members of 7 children with cancer undergoing outpatient treatment, highlighting the significant role of play in the children's lives during their treatment.

Hospital settings can positively influence children's play experiences, suggesting that healthcare professionals, especially nurses, should actively promote play to support the emotional and developmental needs of children with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rescuing the pleasure of playing of child with cancer in a hospital setting. da Silva, LF., Cabral, IE.[2017]

Therapeutic play (TP) significantly reduced anxiety levels in pediatric brain tumor patients undergoing external beam radiotherapy (EBRT), as evidenced by lower scores on anxiety assessments compared to a control group of patients.

Implementing TP not only improved the emotional well-being of young patients during medical procedures but also has the potential to enhance the quality of care and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of therapeutic play for pediatric brain tumor patients during external beam radiotherapy. Tsai, YL., Tsai, SC., Yen, SH., et al.[2021]

Citations

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