NCT06982066

Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention

Improving Health-Related Quality of Life Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Connecticut Children's Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal is to develop and demonstrate proof-of-concept of ReSPECT (Reproductive and Sexual Health Patient Education and Communication Tool), a multi-modal communication intervention to improve adolescent and young adult (AYA)- clinician sexual and reproductive health (SRH) communication in the outpatient oncology clinic setting.

Detailed description

To improve sexual and reproductive health communication between adolescent and young adult oncology patients and their clinicians, the Investigator will be developing and testing proof-of-concept of a novel web-based intervention called ReSPECT (Reproductive and Sexual health Patient Education and Communication Tool). The overarching goal of this proposal is to develop and pilot test a patient-centered approach to improve sexual and reproductive health communication during cancer care. Prior to the clinical trial, Aim 1 of this study will develop and refine ReSPECT by integrating feedback from AYAs and pediatric oncology clinicians on individual intervention components followed by additional feedback collected through cognitive debriefing. Once Aim 1 is completed, the intervention will be ready for proof-of-concept testing. Aims 2 and 3 involve a single-arm cohort study of the ReSPECT intervention using a pre-post design. Enrolled participants will complete a survey at baseline, immediately after intervention use, and at 2 months from study enrollment. All participants will also be invited to participate in a brief interview immediately after intervention use.

Conditions

• Pediatric Cancer
• Adolescent and Young Adult Cancer

Interventions

Type	Name	Description
BEHAVIORAL	ReSPECT	ReSPECT is an interactive, web-based digital platform that integrates (1) an AYA-centered pre-visit questionnaire (PVQ) that will discretely alert clinicians to relevant SRH questions/concerns, (2) targeted patient education on PVQ selections, and (3) clinician-centered guidance for addressing SRH issues. At enrollment, all participants will complete a baseline survey (T1). AYAs will have access to the ReSPECT digital platform and will receive the first prompt to complete the PVQ 3-5 days before their next clinic appointment. Once completed, AYAs will receive an email/text with a link to tailored information based on their PVQ selections for review. Clinicians will receive an email with a link to the patient's PVQ results on the ReSPECT platform along with clinical management recommendations. All participants will complete a brief virtual survey (T2) and interview within 48 hours of the first postintervention clinic visit and a follow-up survey 2 months after study enrollment (T3).

Timeline

• Start date: 2025-02-10
• Primary completion: 2029-03-15
• Completion: 2029-06-29
• First posted: 2025-05-21
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States