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NCT06982066 | RECRUITING | Pediatric Cancer

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

Connecticut Children's Medical Center

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.

Condition or disease

Pediatric Cancer

Adolescent and Young Adult Cancer

Intervention/treatment

ReSPECT

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: A Patient-Centered Intervention
Actual Study Start Date : 2025-02-10
Estimated Primary Completion Date : 2029-03-15
Estimated Study Completion Date : 2029-06-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years to 25 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention

    Location Details

    NCT06982066

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Connecticut

    Connecticut Children's Medical Center

    Hartford, Connecticut, United States, 06106