Improving Health-Related Quality of Life Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
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.
Arms & interventions
- BehavioralReSPECT
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).
Outcome measures
Primary
Feasibility of implementing the ReSPECT intervention.
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.
Time frame: 2 months
Acceptability of the ReSPECT intervention.
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.
Time frame: 2 months
Usability of the ReSPECT intervention.
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.
Time frame: 2 months
Perceived utility of the ReSPECT intervention.
Through qualitative interviews, participants will be asked for their perceptions on the impact of ReSPECT in promoting SRH communication in the outpatient clinic setting.
Time frame: 2 months
Secondary
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
Study locations (1)
Connecticut Children's Medical Center
Hartford, Connecticut, 06106