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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Feasibility of implementing the ReSPECT intervention. [Time frame: 2 months]
• Acceptability of the ReSPECT intervention. [Time frame: 2 months]
• Usability of the ReSPECT intervention. [Time frame: 2 months]
• Perceived utility of the ReSPECT intervention. [Time frame: 2 months]

Secondary outcome measures (9)

• Comparison of patient reported SRH communication before and after intervention implementation. [Time frame: 2 months]
• Comparison of clinician reported SRH communication before and after intervention implementation. [Time frame: 2 months]
• Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation. [Time frame: 2 months]
• Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation. [Time frame: 2 months]
• Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation. [Time frame: 2 months]
• Intervention impact on decision-making. [Time frame: 2 months]
• Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention. [Time frame: 2 months]
• Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention. [Time frame: 2 months]
• Comparison of patient-reported therapeutic alliance before and after the intervention. [Time frame: 2 months]

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:

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

• Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
• Radiotherapy: any radiotherapy to treat the cancer diagnosis.
• Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
• Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.
• Be able to speak and read English
• Have permission to participate from a member of the patient's primary oncology team.
• Provision to sign and date the consent/assent form.
• Active study participation of primary oncology clinician
• 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:

• Not currently on cancer-directed therapy.
• Unable to speak and read English.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Connecticut Children's Medical Center — Hartford

Identifiers

NCT: NCT06982066 · 24-081 · K08CA286736

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗