Clinical trial NCT06982066: Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
Official title: Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: A Patient-Centered Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Adolescent and Young Adult Cancer
Keywords: adolescent young adult
sexual health communication
cancer
patient provider communication
sexual and reproductive health
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria

Adolescent and Young Adult Oncology Patients

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Be aged 15-25 years old at time of enrollment.
2. Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:

   1. Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
   2. Radiotherapy: any radiotherapy to treat the cancer diagnosis.
   3. Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
3. Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.
4. Be able to speak and read English
5. Have permission to participate from a member of the patient's primary oncology team.
6. Provision to sign and date the consent/assent form.
7. Active study participation of primary oncology clinician
8. Patient must have primary oncology care at Connecticut Children's Center for Cancer \& Blood Disorders of Children's Hospital Los Angeles Cancer \& Blood Disease Institute

Exclusion Criteria

An individual who meets and of the following criteria will be excluded from participation in this study:

1. Not currently on cancer-directed therapy.
2. Unable to speak and read English.
3. Insufficient cognitive functioning to complete study measures (as determined by a member of the patient's primary oncology team)

Pediatric Oncology Clinicians

1. Be a pediatric oncology physician, clinical fellow, or advanced practice provider (including nurse practitioners and physician assistants) that provides clinical care for AYA patients with cancer

Primary outcomes:
measure: Feasibility of implementing the ReSPECT intervention.
timeFrame: 2 months
measure: Acceptability of the ReSPECT intervention.
timeFrame: 2 months
measure: Usability of the ReSPECT intervention.
timeFrame: 2 months
measure: Perceived utility of the ReSPECT intervention.
timeFrame: 2 months
Secondary outcomes:
measure: Comparison of patient reported SRH communication before and after intervention implementation.
timeFrame: 2 months
measure: Comparison of clinician reported SRH communication before and after intervention implementation.
timeFrame: 2 months
measure: Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.
timeFrame: 2 months
measure: Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation.
timeFrame: 2 months
measure: Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.
timeFrame: 2 months
measure: Intervention impact on decision-making.
timeFrame: 2 months
measure: Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention.
timeFrame: 2 months
measure: Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention.
timeFrame: 2 months
measure: Comparison of patient-reported therapeutic alliance before and after the intervention.
timeFrame: 2 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: nfrederick@connecticutchildrens.org
name: Natasha Frederick, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: