- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07664241
Peer Support Program for Improving Quality of Life Among Head and Neck Patients, Connecting Through Cancer Trial
Connecting Through Cancer: Feasibility of a Peer Support Program for Head and Neck Patients
연구 개요
상세 설명
Primary objective:
I. Examine the feasibility of a peer support program for head and neck cancer patients.
Secondary objective:
I. Collect qualitative and quantitative data on the utilization of the mentorship program.
Exploratory objective:
I. Descriptive analysis of mentee psychosocial wellbeing over time. II. Descriptive analysis of caregiver burden over time.
Outline:
Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alexandria Lichtl, MD
- 전화번호: 5037061729
- 이메일: lichtl@ohsu.edu
연구 장소
-
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Oregon
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Portland, Oregon, 미국, 97239
- OHSU Knight Cancer Institute
-
연락하다:
- Ryan J. Li, MD
- 전화번호: 302-893-4959
- 이메일: lry@ohsu.edu
-
수석 연구원:
- Ryan J. Li, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- MENTEE GROUP: Ability to understand and the willingness to sign a written informed consent document
- MENTEE GROUP: Willingness to have mentor-mentee interactions with the mentor selected by Imerman Angels (documented as part of informed consent)
- MENTEE GROUP: Age 18 or older at the time of consent (upper age limit 89)
- MENTEE GROUP: Diagnosed with head & neck cancer (all stages) and planning to receive, currently receiving or recently completed (within 12 months) active treatment OR in follow-up and reporting unmet social/support needs
- MENTEE GROUP: English-speaker
- MENTEE GROUP: Access to electronic device that can be used for communication
- MENTEE GROUP: Eastern Cooperative Oncology Group (ECOG) score less than or equal to 2
- CAREGIVER GROUP: Ability to understand and the willingness to sign a written informed consent document
- CAREGIVER GROUP: Age 18 or older at the time of consent (upper age limit 89)
- CAREGIVER GROUP: Caregiver of patient diagnosed with head and neck cancer who is also enrolled in the study
- CAREGIVER GROUP: English-speaker
- CAREGIVER GROUP: Access to electronic device that can be used for communication
Exclusion Criteria:
- MENTEE GROUP: Mentee must not be regularly engaging in other support programs at the start of the study intervention
- MENTEE GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- MENTEE GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
- CAREGIVER GROUP: Caregivers must not be regularly engaging in other support programs at the start of the study intervention
- CAREGIVER GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- CAREGIVER GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
공부 계획
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: Supportive Care (peer support program)
Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study. Caregivers of enrolled mentees may also participate on an optional basis by completing study surveys; however, caregivers will not directly participate in the peer mentorship intervention. |
보조 연구
보조 연구
Participate in peer support program
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of mentees meeting with their mentor match at least once
기간: Up to 6 months
|
Will be reported with 95% asymptotic confidence interval.
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Up to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Utilization of the mentorship program
기간: Up to 6 months
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Mean and standard deviation will be reported for number of times the mentor and mentee have made contact.
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Up to 6 months
|
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Mentorship conversation topics
기간: Up to 6 months
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Proportions of categories will be reported for topics discussed between mentor and mentee.
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Up to 6 months
|
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Rating scale for match
기간: Up to 6 months
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Mean and standard deviation will be reported for rating scale for match (in terms of similar demographics and cancer experience).
This will be on a 1-10 scale, with 10 being the most similar match.
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Up to 6 months
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Qualitative data on the benefits and challenges of the mentorship program
기간: Up to 6 months
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A subset of mentees (estimated n=10-15) will complete structured exit interviews at 6 months.
Interviews will explore perceived benefits, challenges, barriers to engagement, impact on decision-making, and recommendations for program improvement.
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Up to 6 months
|
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Satisfaction with peer mentor contacts
기간: Up to 6 months
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Satisfaction will be measured using a survey that was used in a prior pilot study on a one-on-one cancer peer support program by Valanjow and Weis (2024).
The survey contains 14 statements and mentees will be asked to rate how much they feel the statement applies.
The scale ranges from 1-5 (1= not applicable and 5=fully applies).
Mean and standard deviation of the Likert score will be reported for each item at each time point.
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Up to 6 months
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Demographic differences between matched mentees who meet with their mentor and those who do not
기간: Up to 6 months
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Descriptive univariate analysis to evaluate demographic differences between matched mentees who meet with their mentor and those who do not.
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Up to 6 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mentee psychosocial well-being over time
기간: Up to 6 months
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Mentees will complete short surveys analyzing coping, anxiety and depression at three different time points to track changes over time.
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Up to 6 months
|
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Caregiver burden over time (optional)
기간: Up to 6 months
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Caregivers will complete surveys on caregiver burden at three different time points to track changes over time.
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Up to 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ryan J Li, MD, OHSU Knight Cancer Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00029208 (기타 식별자: OHSU Knight Cancer Institute)
- NCI-2026-00407 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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