Education Tools to Support Pediatric Survivor Care

• Sponsor: Emory University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04257058
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.8
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

This study aims to evaluate the impact of electronic educational materials on adolescent and young adult ("AYA") survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Pediatric Cancer	Behavioral: Electronic educational material	N/A

Detailed Description

Despite increased risk for morbidity and mortality related to cancer treatment, over half of young adult survivors of childhood cancer do not engage in the recommended healthcare designed to detect late effects and secondary cancers. There is a scarcity of data on adherence to survivor-focused healthcare, particularly at the critical transition from pediatrics to adult care. In order to improve transition outcomes, the investigators need to create media to educate survivors about need for adherence to adult survivor healthcare.

This study aims to evaluate the impact of electronic educational materials on AYA survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluating Education Tools to Support Pediatric Cancer Survivor Care Across the Lifespan (Administrative Supplement to R01CA218389)
• Actual Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electronic educational material Participants will complete an online pre-test survey via REDCap. One week after the pre-test survey is completed, AYAs will be sent electronic media via email to review on their own. Study staff will confirm receipt and review of material and schedule a post-test survey to be completed in REDCap two weeks after material is reviewed.	Behavioral: Electronic educational material; Electronic media via email

Outcome Measures

Primary Outcome Measures

1. Change in knowledge [Baseline, 2 weeks post-intervention]

   Knowledge will be assessed at baseline and 2 weeks post-intervention, with the Survivor Care Knowledge scale, that includes 15-item multiple-choice quiz to assess participants' knowledge of the content covered in the electronic educational materials previously provided. Total score ranges from 0-15. Higher score is associated with better outcome.

Secondary Outcome Measures

1. Change in Champion Benefits Scale for Mammography screening [Baseline, 2 weeks post-intervention]

   5-item study adapted Champion Benefits Scale for Mammography Screening. Total score ranges from 5-25. Lower score equals fewer perceived benefits of survivor care

2. Change in Champion Barriers Scale for Mammography Screening [Baseline, 2 weeks post-intervention]

   11-item study adapted Champion Barriers Scale for Mammography Screening. Total score ranges from 11-55. Lower score equals fewer perceived barriers to survivor care

3. Change in Champion Susceptibility Scale for Mammography Screening [Baseline, 2 weeks post-intervention]

   3-item study adapted Champion Susceptibility Scale for Mammography Screening. Total score ranges from 3-15. Lower score equals less susceptibility to late effects of treatment

4. Change in Intentions for survivor care [Baseline, 2 weeks post-intervention]

   2-item study adapted Ajzen's Theory of Planned Behavior- Intentions. Total score ranges from 2-14. Lower score equals greater intention to engage in long-term follow-up care

5. Change in Perceived Health Competence Scale (PHCS) [Baseline, 2 weeks post-intervention]

   8-item Perceived Health Competence Scale (PHCS). total score ranges from 8-40. Lower score equals lower perceived health competence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients must be 18-25 years of age,

• Diagnosed with cancer at ≤ 18 years of age,

• ≥ 2 years since the last cancer treatment,

• seen at least once in the Aflac CSP in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013.

Exclusion Criteria:

• Patients and/or parents will be excluded from participation in the study if the participant is non-English speaking.

• Young adult survivors who are cognitively impaired and unable to complete the questionnaires.

• Participants that do not consent to the recording of their interviews.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Jordan Marchak, PhD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jordan Marchak, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT04257058
• Other Study ID Numbers: IRB00091839
• First Posted: Feb 5, 2020
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jordan Marchak, Associate Professor, Emory University: Behavioral study; Social study; Pediatric cancer

Study Results

No Results Posted as of Jun 8, 2022