Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
- Conditions
- Pediatric CancerAdolescent and Young Adult Cancer
- Registration Number
- NCT06982066
- Lead 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Feasibility of implementing the ReSPECT intervention. 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.
Acceptability of the ReSPECT intervention. 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.
Usability of the ReSPECT intervention. 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.
Perceived utility of the ReSPECT intervention. 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 Outcome Measures
Name Time Method Comparison of patient reported SRH communication before and after intervention implementation. 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.
Comparison of clinician reported SRH communication before and after intervention implementation. 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.
Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation. 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.
Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation. 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.
Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation. 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.
Intervention impact on decision-making. 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.
Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention. 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.
Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention. 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.
Comparison of patient-reported therapeutic alliance before and after the intervention. 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.
Trial Locations
- Locations (1)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States