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

2026년 6월 15일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90027
        • Children's Hospital Los Angeles
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ReSPECT Intervention Arm
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility (as assessed by intervention completion and retention rates)
기간: 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)
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Exchange of Information
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Connecticut Children's Medical Center

협력자

National Cancer Institute (NCI)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 15일

기본 완료 (추정된)

2028년 6월 30일

연구 완료 (추정된)

2029년 6월 30일

연구 등록 날짜

최초 제출

2026년 6월 2일

QC 기준을 충족하는 최초 제출

2026년 6월 15일

처음 게시됨 (실제)

2026년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 15일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
  • K08CA286736-01A1 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

암에 대한 임상 시험

ReSPECT에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Malawi

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다