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

Connecticut Children's Medical Center

Status

Enrolling

Conditions

Adolescent and Young Adult Cancer

Pediatric Cancer

Treatments

Behavioral: ReSPECT

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06982066

K08CA286736 (U.S. NIH Grant/Contract)

24-081

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

15 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:
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.
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

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