PLAY Program for Childhood Cancer Survivors

(PLAY Trial)

Overseen By Moscato Lab Email

Age: 18+

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

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the PLAY Program treatment for childhood cancer survivors?

Research shows that multidisciplinary rehabilitation, which may include play activities, significantly improves the quality of life and physical fitness in childhood cancer survivors. This suggests that programs like the PLAY Program could be beneficial in enhancing the well-being of these children. ^{1 2 3 4 5}

Is the PLAY Program for Childhood Cancer Survivors safe for humans?

The available research highlights the importance of monitoring long-term health effects in childhood cancer survivors, but it does not provide specific safety data for the PLAY Program. However, efforts are being made to collect safety data on therapies for childhood cancer, which may include programs like PLAY. ^{6 7 8 9 10}

How does the PLAY Program treatment differ from other treatments for childhood cancer survivors?

The PLAY Program is unique because it focuses on using structured active play to support social and personal development in childhood cancer survivors, unlike traditional treatments that primarily address physical health. This approach aims to enhance the quality of life by integrating play therapy, which can reduce anxiety and improve emotional well-being. ^{4 5 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to test and improve an online program for caregivers of young childhood cancer survivors called the Preparing for Life and Academics for Young survivors program (PLAY). The PLAY program was created with a group of caregivers of young children with cancer and healthcare providers. Ultimately, investigators hope to see if the program can improve positive parenting behaviors, reduce caregiver stress, and help get young children ready for school. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions: 1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program? 2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use? 3. Are caregivers of childhood cancer survivors satisfied with the PLAY program? 4. How can the PLAY program be improved in the future? When the child is transitioning to maintenance phase therapies or off cancer treatment, caregivers will be invited to participate and complete surveys when they begin the study as well as a videotaped interaction task with their child. Children will complete brief developmental testing at the beginning of the program. Caregivers will then complete the PLAY Program, which will involve completing 7 weekly or bi-weekly online modules and meeting with a trained coach by videoconference for up to 8 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and help their family adjust and cope with stress. Caregivers will repeat the surveys and videotaped interaction task again three months later, after the PLAY program is completed. They will also be invited to participate in an interview to learn about their experience in the program.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: PLAY program Experimental Treatment 1 Intervention

PLAY is a digital health intervention involving 6 self-directed web-modules and 8 virtual coaching sessions (6 paired plus 2 booster sessions) for caregivers of young childhood cancer survivors (3-6 years).

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

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

The measurement of performance in childhood cancer patients. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Large Improvements in Health-Related Quality of Life and Physical Fitness during Multidisciplinary Inpatient Rehabilitation for Pediatric Cancer Survivors. [2023]

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

Supportive care in pediatric oncology. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Exploring play therapy in pediatric oncology: a preliminary endeavour. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Rescuing the pleasure of playing of child with cancer in a hospital setting. [2017]

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

The Childhood Cancer Survivor Study: a National Cancer Institute-supported resource for outcome and intervention research. [2022]

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

Factors associated with recruiting adult survivors of childhood cancer into clinic-based research. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The development of a new information model for a pediatric cancer registry on late treatment sequelae in The Netherlands. [2004]

9. England 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. [2019]

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

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. [2022]

11. England 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. [2023]

12. Japan 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]. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of therapeutic play for pediatric brain tumor patients during external beam radiotherapy. [2021]