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NCT Number: NCT06982066

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

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.

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Key information

Conditions

Pediatric Cancer Adolescent and Young Adult Cancer Behavior Coitus Neoplasms Sexual Behavior

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Natasha Frederick, MD, MPH

CONTACT

[email protected]

860-545-9618

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

ReSPECT

Behavioral

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).

Primary outcomes

  1. Feasibility of implementing the ReSPECT intervention.

    Time frame: 2 months

    Feasibility will be based on patient recruitment and completion of the intervention. The intervention will be considered feasible if AYA recruitment is greater than or equal to 60% and if greater than or equal to 80% of consented AYAs complete the intervention (retention). Intervention completion will be defined as AYA completion of the pre-visit questionnaire and post-intervention survey.

  2. Acceptability of the ReSPECT intervention.

    Time frame: 2 months

    The intervention will be considered acceptable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as acceptable (average score of 4 or higher) on the Lyon Satisfaction Questionnaire, adapted for this study, which includes a 10-item satisfaction questionnaire where 1 is strongly disagree and 5 is strongly agree. Subjects will report via survey after the healthcare visit.

  3. Usability of the ReSPECT intervention.

    Time frame: 2 months

    The intervention will be considered usable/sustainable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as usable (average score of 4 or higher) on the Usability/Sustainability of Intervention Scale, adapted for this study, on a 4-item usability questionnaire where 1 is strongly disagree and 5 is completely agree. Subjects will report via survey after the healthcare visit.

  4. Perceived utility of the ReSPECT intervention.

    Time frame: 2 months

    Through qualitative interviews, participants will be asked for their perceptions on the impact of ReSPECT in promoting SRH communication in the outpatient clinic setting.

Secondary outcomes

  1. Comparison of patient reported SRH communication before and after intervention implementation.

    Time frame: 2 months

    Comparison of pre- and post- intervention percentage of patients reporting that their clinician talked to them about a SRH topic during the most recent clinic visit. Subjects will report via survey (yes/no) at baseline and after their healthcare visit.

  2. Comparison of clinician reported SRH communication before and after intervention implementation.

    Time frame: 2 months

    Comparison of pre- and post- intervention percentage of clinicians reporting that they talked to their AYA patient about a SRH topic during the most recent clinic visit. Subjects will report (yes/no) via survey at baseline and after the healthcare visit.

  3. Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.

    Time frame: 2 months

    Comparison of pre- and post- intervention patient report of confidence in talking to their oncology clinician about SRH. Patients will complete a multi-item questionnaire adapted for this study on confidence where 0 is "not at all confident" and 10 is "extremely confident." Subjects will report via survey at baseline and after the healthcare visit.

  4. 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 pre- and post- intervention clinician report of confidence in talking to their AYA clinician about SRH. Patients will complete a multi-item questionnaire adapted for this study on confidence where 0 is "not at all confident" and 10 is "extremely confident." Subjects will report via survey at baseline and after the healthcare visit.

  5. Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.

    Time frame: 2 months

    Comparison of pre- and post- intervention patient report of perceived benefit of discussing SRH with their clinician. Patients will complete a 6-item questionnaire adapted for this study on perceived benefit where 0 is "not at all" and 10 is "very much." Subjects will report via survey at baseline and after the healthcare visit.

  6. Intervention impact on decision-making.

    Time frame: 2 months

    The proportion of patients that report the intervention helped them get the information that they needed to make informed decisions about SRH. Subjects will report (yes/no) via survey after their healthcare visit.

  7. Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention.

    Time frame: 2 months

    Comparison of pre- and post- intervention rating of distress/bother by SRH-related questions or concerns. Patients will complete a single item scale on the degree of bother on the Distress/Bother Scale where 1 is "Not at all bothersome" and 4 is "Bothers me a lot". Subjects will report via survey at baseline and after the healthcare visit.

  8. Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention.

    Time frame: 2 months

    Comparison of patient-reported engagement in sexual health risk behaviors pre- and post- intervention implementation. Patients will complete a study-specific survey consisting of several questions about engagement in sexual health risk behaviors (yes/no and nominal). Subjects will report via survey at baseline and after the healthcare visit.

  9. Comparison of patient-reported therapeutic alliance before and after the intervention.

    Time frame: 2 months

    Comparison of patient-reported therapeutic alliance with primary oncology clinician pre- and post- intervention implementation. Patients will complete 16 items on The Human Connection Scale (4-point scale). Subjects will report via survey at baseline and after the healthcare visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha Frederick, MD, MPH

CONTACT

[email protected]

860-545-9618

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 21, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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