Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being (LWBC)
2026년 6월 2일 업데이트: University of Colorado, Denver
Pilot Study of the Living Well With Brain Cancer Intervention
The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:
- Is it feasible to conduct this program?
- Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?
연구 개요
연구 유형
중재적
등록 (추정된)
64
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Research Services Professional
- 전화번호: 303-724-1723
- 이메일: lwbc@cuanschutz.edu
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Anschutz
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연락하다:
- Research Services Professional
- 이메일: LWBC@cuanschutz.edu
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수석 연구원:
- Bethany M Kwan, PhD, MSPH
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
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수석 연구원:
- Molly McVoy, MD
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Currently living in the United States
- Aged 18 years or older
- Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)
- Treating prescribing provider who follows regularly with participant
Exclusion Criteria:
- <1 month since initial diagnosis and/or <1 month since surgical resection
- Enrollment in hospice
- Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed
- Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
- Not able to communicate in English at a conversational level
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group Self-Management Arm
Participants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content.
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Our targeted self-management intervention will be delivered virtually through eight 90-minute sessions over a 3-4-month period using materials adapted from previous focus groups of people with brain cancer and an expert design panel.
A nurse educator and peer educator will facilitate the virtual sessions.
The content covers topics focused on how to improve the quality of life in people diagnosed with brain cancer.
다른 이름들:
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활성 비교기: Education Only Arm
Participants in this arm will be invited to use an online learning management system to access the educational materials.
There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials.
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Self-management content specifically designed for people with brain cancer will be uploaded into a learning management system.
The content will be broken up into modules that will be unlocked at the same frequency as the self-management group sessions arm.
There are no group sessions involved, and there are no nurse or peer educators to lead the participants through this content.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
기간: Baseline, immediately post-intervention, and 3 months post-intervention
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Evaluated by the change overall score of the RAND 36-Item Short Form Survey Instrument (SF-36) at baseline, immediate after intervention, and 3 months post-intervention
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Baseline, immediately post-intervention, and 3 months post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
기간: Baseline and immediately post-intervention
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Change from Baseline to immediately after intervention in score of NIH Toolbox Item Bank v3.0 - Percevied Stress (Ages 18+) - Fixed Form
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Baseline and immediately post-intervention
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Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
기간: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention in score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
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Baseline and immediately post-intervention
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Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
기간: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey
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Baseline and immediately post-intervention
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Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
기간: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey
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Baseline and immediately post-intervention
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Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
기간: Baseline
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Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys
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Baseline
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Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
기간: Baseline
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Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys
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Baseline
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Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
기간: Baseline and immediately post-intervention
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Change in score from baseline to immediately post-intervention of the Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activites - Short Form survey
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Baseline and immediately post-intervention
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Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
기간: Baseline and immediately post-intervention
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Change in score from baseline to immediately post-intervention from the Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form survey
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Baseline and immediately post-intervention
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Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
기간: Baseline and immediately post-intervention
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Change in score from baseline to immediately post-intervention from the PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a survey
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Baseline and immediately post-intervention
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Survival
기간: Immediate post-intervention, 3 months post-intervention
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Self/contact-reported survival
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Immediate post-intervention, 3 months post-intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Bethany M Kwan, PhD, MSPH, University of Colorado, Denver
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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- Boele FW, den Otter PWM, Reijneveld JC, de Witt Hamer PC, van Thuijl HF, Lorenz LMC, Wesseling P, Lagerwaard FJ, Taphoorn MJB, Kouwenhoven MCM, Snijders TJ, Douw L, Klein M. Long-term wellbeing and neurocognitive functioning of diffuse low-grade glioma patients and their caregivers: A longitudinal study spanning two decades. Neuro Oncol. 2023 Feb 14;25(2):351-364. doi: 10.1093/neuonc/noac185.
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 6월 1일
기본 완료 (추정된)
2027년 10월 31일
연구 완료 (추정된)
2027년 10월 31일
연구 등록 날짜
최초 제출
2026년 5월 26일
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-2124
- HT9425-24-1-0883 (기타 보조금/기금 번호: U.S. Army Medical Research Acquisition Activity (USAMRAA))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
The datasets generated during and/or analyzed during the current study will not be publicly available, but will be available from the primary investigator on reasonable request.
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. .
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