Preparing for Life and Academics for Young Childhood Cancer Survivors

NCT06769334 | Recruiting

• 2 other identifiers: STUDY00004302K08CA290060
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?
2. 2.Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?
3. 3.Are caregivers of childhood cancer survivors satisfied with the PLAY program?
4. 4.How can the PLAY program be improved in the future?
5. 5.Does PLAY help improve how caregivers interact and read with their children or how they manage their own stress?

Conditions

Childhood Cancer

Keywords

positive parenting; development; school readiness; digital health; caregiver stress; school advocacy

Outcome Measures

Primary Outcomes (5)

• System Usability Scale

  This is a 10-item measure that will quantitatively assess usability of our web-based program. The SUS measures how accessible the website is and whether participants can understand the content of the website on a scale of 0-100. We will continue to recruit until our website has achieved an average score of \>68% (above average).

  3 months post-enrollment

• Intervention Appropriateness Measure (IAM)

  Participants will use this four-item measure to rate the appropriateness of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more appropriate, an overall score of 4 or higher (80%) means a participant found the program to be appropriate.

  3 Months Post-Enrollment

• Acceptability of Intervention Measure (AIM)

  This is a four-item measure that will have participants rate the acceptability of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more acceptable, an overall score of 4 or higher (80%) means a participant found the program to be acceptable.

  3 Months Post-Enrollment

• Adapted Website Evaluation Questionnaire (WEQ)

  This measure will assess accessibility and satisfaction with the PLAY Program. Four overall items will be rated from 1-10 by participants. The overall score will be the average response across items. A higher score indicates higher satisfaction with the program. Overall scores of 8 or higher (\> 80%) are an indication of satisfaction with the PLAY program.

  3 months post-enrollment

• Feasibility of the PLAY program

  Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%), completion rate (# completing core PLAY sessions/#enrolled; milestone greater than or equal to 75%), retention rate (#completers of 3 and 6 month assessments/ # enrolled at baseline; milestone greater than or equal to 70%); Caregivers who rate the intervention greater than or equal to 80% on the Feasibility Intervention Measure (FIM; milestone \>80%), which is a four-item measure. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.

  3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)

Secondary Outcomes (3)

• Play and Alternative Learning Strategies parent-child interaction coding

  Baseline, 3 and 6 month follow up (Phase II)

• Parenting Stress Index-Short Form

  Baseline, 3 and 6 months post-enrollment (Phase II)

• Hospital Depression and Anxiety Scale (HADS)

  Baseline, 3 and 6 months post-enrollment (Phase II)

Other Outcomes (2)

• Behavior Rating Inventory of Executive Function (BRIEF-P or -2)

  Baseline, 3 and 6 months post-enrollment (Phase II)

• Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale)

  Baseline, 3 and 6 months post-enrollment (Phase II)

Study Arms (1)

Preparing for Life and Academics for Young (PLAY) survivors program

EXPERIMENTAL

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.

Other: PLAY Program

Interventions

PLAY Program OTHER

The PLAY Program is a web-based program created for caregivers of childhood cancer survivors. The program consists of seven modules with the following topics: 1) Introduction to the program 2) Self-Care 3) Relationships 4) Getting Ready for School 5) Talking, Reading, and Counting together 6) Social and Emotional Development 7) Review Module. The program is meant to be completed over approximately three months, and caregivers in the program will meet with a coach on a weekly or bi-weekly basis to discuss what they learned in the modules and how to practice it in their daily lives.

Preparing for Life and Academics for Young (PLAY) survivors program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Has a documented neurodevelopmental disorder prior to their cancer diagnosis (e.g., neurofibromatosis, tuberous sclerosis, Down's syndrome, autism)
• Did not receive any treatment for their cancer (e.g., chemotherapy, surgical resection, radiation)
• Treated for a benign tumor
• For the teacher:
• Classroom or daycare teacher of the childhood cancer survivor

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (71)

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MeSH Terms

Conditions

Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Emily L Moscato, PhD

CONTACT

614-722-4724; moscato_lab@nationwidechildrens.org

Cynthia Gerhardt, PhD

CONTACT

cynthia.gerhardt@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Staff members who are completing the coding for the standardized parent-child interaction task will be blinded to time point.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: December 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be made available after the primary outcomes manuscript is published and will be available for at least seven years post study-closure.
• Access Criteria: Interested parties will be able to access the IPD by contacting the PI or through request at the Inter-university Consortium for Political and Social Research.

Locations

US (1)