An interventional study of ReSPECT in Pediatric Cancer and Adolescent and Young Adult Cancer, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Connecticut Children's Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Connecticut Children's Medical Center is the lead sponsor of 59 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:
Exclusion Criteria
An individual who meets and of the following criteria will be excluded from participation in this study:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: ReSPECT
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).
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
Comparison of patient reported SRH communication before and after intervention implementation.
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.
Time frame: 2 months
Comparison of clinician reported SRH communication before and after intervention implementation.
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.
Time frame: 2 months
Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.
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.
Time frame: 2 months
Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation.
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.
Time frame: 2 months
Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.
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.
Time frame: 2 months
Intervention impact on decision-making.
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.
Time frame: 2 months
Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention.
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.
Time frame: 2 months
Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention.
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.
Time frame: 2 months
Comparison of patient-reported therapeutic alliance before and after the intervention.
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.
Time frame: 2 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Connecticut Children's Medical Center