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Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients (ReSPECT)

15. Juni 2026 aktualisiert von: Connecticut Children's Medical Center

Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing

The goal of this clinical trial is to learn if ReSPECT, which includes a pre-visit checklist for patients to complete and an informational website, can work well in practice to help adolescent and young adult oncology patients communicate with their clinicians about sexual and reproductive health (SRH). SRH includes topics such as how cancer may impact puberty and development, best methods for contraception during cancer treatment, fertility risk and fertility preservation strategies, and dating/relationships during and after cancer. The study will also help researchers better understand how to best measure the impact of ReSPECT on improving SRH communication for future testing of ReSPECT.

The main questions the study aims to answer are:

How well does ReSPECT work in practice? Do patients and clinicians like ReSPECT, and do they find it helpful? What are the best ways to test ReSPECT and measure whether it works?

Participants will:

Use ReSPECT to support a conversation about SRH during an outpatient oncology clinic appointment Complete surveys before and after using ReSPECT Provide feedback on their experience using ReSPECT in a short interview

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Psychosexual development is a key aspect of adolescence and young adulthood, which may be significantly disrupted by a cancer diagnosis. Adolescent and young adult (AYA) cancer patients are at risk for complications that can detrimentally impact their sexual and reproductive health (SRH) during and after cancer treatment. Prior research has shown that pediatric oncologists rarely discuss many important aspects of SRH, and AYA cancer patients repeatedly report unmet communication needs related to these topics.

To address these needs, we have developed ReSPECT, an interactive, web-based digital platform designed to improve communication about insufficiently addressed SRH topics. ReSPECT integrates (1) a pre-visit questionnaire (PVQ) that will allow AYA patients to discreetly alert clinicians to relevant SRH questions/concerns (2) targeted patient education based on PVQ selections, and (3) clinician-centered guidance for addressing specific SRH questions/concerns. Previous stages of this research involved developing and refining a prototype of ReSPECT based on stakeholder feedback. Utilizing this prototype, this proof-of-concept study will assess the feasibility, acceptability, and perceived usefulness of ReSPECT with AYA patients on active cancer treatment and their oncology clinicians. In addition to assessing operational viability, this study will also assess the feasibility of collecting secondary outcomes measures. Data collected will lay the foundation for a future randomized controlled trial to assess ReSPECT intervention efficacy, with the ultimate goal of improving HRQOL communication for AYAs across the cancer continuum.

Primary Aim: Evaluate the feasibility, acceptability, usability, and perceived usefulness of ReSPECT in the outpatient setting with AYA oncology patients and clinicians.

ReSPECT will undergo proof-of-concept testing with AYAs (n=30) and their oncology clinicians (n~10-30) to determine if the intervention is feasible (recruitment >60%, retention >80%), acceptable (>70% with an average score ≥4 on the Lyon Satisfaction Questionnaire), and perceived useful (>70% with an average score ≥4 on the Usability/Sustainability of Intervention scale). Qualitative interviews with participants will provide additional information on acceptability, perceived usefulness, and opportunities for intervention improvement.

Secondary Aim: Collect and examine descriptive data on preliminary outcomes of ReSPECT and assess feasibility of procedures for a future randomized controlled trial.

Pre- and post-intervention questionnaires (T1: pre-visit, T2: within 48 hrs post-visit, T3: 8 weeks post-visit) to assess signals of intervention efficacy will include communication behavior, self-efficacy, outcome expectancies, decision-making, therapeutic alliance, distress/bother, and developmentally relevant health risk behaviors.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90027
        • Children's Hospital Los Angeles
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Age 15-25 years old
  • Has a cancer diagnosis
  • ≥2 months from diagnosis/initiation of therapy, whichever occurred later
  • Currently on cancer-directed therapy
  • Speaks and reads English
  • Approval from primary oncology team
  • Study participation by primary oncology clinician

Exclusion Criteria:

  • Not able to provide informed consent/assent
  • Insufficient cognitive functioning to complete study measures, as determined by a member of the patient's primary oncology team
  • Exceeds primary oncologist's participant limit (3 patients/clinician)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ReSPECT Intervention Arm
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
Verhalten: ReSPECT
ReSPECT is a multi-modal digital intervention that integrates a pre-visit questionnaire and targeted patient and clinician education to support SRH communication in the outpatient oncology clinic setting. For the purposes of this study it will be used in conjunction with a single regularly scheduled clinic visit.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility (as assessed by intervention completion and retention rates)
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
Feasibility will be evaluated based on intervention completion (% of AYAs completing all steps through T2) and retention (% of enrolled AYAs and clinicians completing all steps through T3). ReSPECT will be deemed feasible if intervention completion and retention rates are ≥80% and ≥70%, respectively.
From enrollment until T3 survey completion (8 weeks post-visit)
Acceptability (as assessed by Lyon Satisfaction Questionnaire)
Zeitfenster: From enrollment until T2 survey completion (within 48 hours post-visit)
Acceptability will be measured using the 11-item Lyon Satisfaction Questionnaire, included in the T2 survey, with a threshold of ≥70% of AYA and clinician participants rating the intervention acceptable (average score 4 or higher).
From enrollment until T2 survey completion (within 48 hours post-visit)
Perceived Usefulness (as assessed by Intervention Usability/Sustainability Scale, qualitative interviews)
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
Perceived Usefulness will encompass usability and utility. Usability will be assessed by the 4-item Intervention Usability/Sustainability Scale, included in the T2 and T3 surveys, with a threshold of ≥70% of AYA and clinician participants rating the intervention usable (average score 4 or higher). Utility will be evaluated in post-encounter qualitative interviews with AYAs and clinicians.
From enrollment until T3 survey completion (8 weeks post-visit)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Exchange of Information
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
Initiation and content of AYA-clinician SRH conversations will be evaluated with a three-item instrument adapted for this study from similar health communication research
From enrollment until T3 survey completion (8 weeks post-visit)
Self-Efficacy
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
Self-efficacy will be measured by a two-item scale assessing AYA and clinician confidence (1) initiating and (2) participating in discussions about SRH topics. Responses range from 0 (not at all confident) to 10 (extremely confident) for each topic.
From enrollment until T3 survey completion (8 weeks post-visit)
Fostering Healing Relationships (Therapeutic Alliance)
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
The Human Connection (THC) scale is a 16-item scale measuring therapeutic alliance (TA) between AYAs and clinicians. Items are scored on a 4-point Likert scale, with response categories based on question content, and higher scores indicating greater TA.
From enrollment until T3 survey completion (8 weeks post-visit)
Decisional Confidence (Decision Making)
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
Decisional confidence will be assessed by a single-item survey measure to assess whether ReSPECT helped AYAs make an informed decision about a SRH question/concern. Participants will be asked to respond with yes/no, then to describe why/why not.
From enrollment until T3 survey completion (8 weeks post-visit)
Distress/Bother
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
The Level of Bother Scale is a single-item scale assessing the extent to which participants have been bothered by specific SRH concerns in the last month. Responses are scored on a 4-point Likert scale, with higher scores indicating greater levels of bother.
From enrollment until T3 survey completion (8 weeks post-visit)
Outcome Expectancies
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
The Outcome Expectancy Scale is a 6-item scale assessing AYA's perception of the extent to which outcomes may result from discussing SRH topics with their oncology clinician. Potential outcomes include answering question(s), finding a solution to a problem, giving peace of mind, helping play an active role in one's health care, improving SRH, and helping make decisions. For each item, responses range from 0 (not at all) to 10 (very much).
From enrollment until T3 survey completion (8 weeks post-visit)
Risk Behaviors (Decision Making)
Zeitfenster: From enrollment until T3 survey completion (8 weeks post-visit)
A 9-item questionnaire adapted from the National Youth Risk Behavior Survey will be used to characterize quality and frequency of health risk behaviors among AYA participants.
From enrollment until T3 survey completion (8 weeks post-visit)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Connecticut Children's Medical Center

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Natasha N Frederick, MD, MPH, Connecticut Children's Medical

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. November 2026

Primärer Abschluss (Geschätzt)

30. Juni 2028

Studienabschluss (Geschätzt)

30. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

2. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juni 2026

Zuerst gepostet (Tatsächlich)

22. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
  • K08CA286736-01A1 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Given the relatively small sample size and the rarity of pediatric cancer, even after removal of identifiers we believe a risk remains of deductive identification of participants. Consequently, we are not planning to share IPD.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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