Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING)
2020년 8월 10일 업데이트: Shelley Johns, Indiana University
Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers
The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid malignancies and their family caregivers.
연구 개요
상세 설명
Mindfulness meditation practices have reduced emotional distress, avoidant coping, and improved spiritual well-being in adult cancer patients. These beneficial effects may occur through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and adaptive coping through self-awareness, self-regulation, and self-transcendence. Most mindfulness trials in cancer have focused on early-stage survivors; however, preliminary evidence suggests that mindfulness may help reduce distress in patients with advanced cancer and their family caregivers (FCGs).
Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be randomized in equal numbers to receive either the 6-week mindfulness intervention or usual care. Both groups will receive standard cancer care throughout the study period. Dyads randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body scan, sitting meditation) and mindful communication practices to enhance quality of life, support advance care planning engagement, and improve a variety of secondary outcomes.
The study will use a mixed methods 2-arm randomized design to examine the effects of the mindfulness intervention compared to usual care and seek to explain trial results using insights gleaned from post-intervention qualitative interviews.
연구 유형
중재적
등록 (실제)
108
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria-Patients
- Patient is at least 18 years of age.
- Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or metastatic) solid malignancy.
- Patient's attending medical oncologist would not be surprised if the patient died in the next 12 months.
- Patient has not completed a POST form.
- Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance subscale.
- Patient is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
- Patient has a family member or close friend eligible and interested in participating in the study.
- Patient has adequate English fluency for completion of data collection
Inclusion Criteria-Family Care Givers (FCG)
- FCG is at least 18 years of age.
- FCG has been invited to participate in the trial with a patient who meets eligibility criteria above.
- FCG is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
- FCG has adequate English fluency for completion of data collection
Exclusion Criteria-Patients
- Patient reports a score of > 2 on the Activities and Function item from the Patient Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score).
- Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
- Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
Exclusion Criteria-FCGs
• FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
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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간섭 없음: Usual Care
Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers.
At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges.
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활성 비교기: Mindfulness
The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion.
The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
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The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations.
Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice.
Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week.
Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in quality of life (QoL) for Patients
기간: Baseline, 6 weeks, and 10 weeks
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QoL for patients will be assessed with the McGill Quality of Life Inventory.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in quality of life (QoL) for Family Caregivers
기간: Baseline, 6 weeks, and 10 weeks
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QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC).
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Baseline, 6 weeks, and 10 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in advance care planning (ACP) stage of change
기간: Baseline, 6 weeks, and 10 weeks
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ACP stage of change will be assessed by a measure modified from Fried et.
al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure).
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in advance care planning (ACP) engagement
기간: Baseline, 6 weeks, and 10 weeks
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ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure).
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in caregiver burden
기간: Baseline, 6 weeks, and 10 weeks
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Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in avoidant coping
기간: Baseline, 6 weeks, and 10 weeks
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Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in avoidant coping
기간: Baseline, 6 weeks, and 10 weeks
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Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in depressive symptoms
기간: Baseline, 6 weeks, and 10 weeks
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Depressive symptoms will be assessed using the PHQ-8
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in anxiety
기간: Baseline, 6 weeks, and 10 weeks
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Anxiety will be assessed using the GAD-7
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in spiritual well-being
기간: Baseline, 6 weeks, and 10 weeks
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Spiritual well-being will be measured using the FACIT-SP.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in sleep disturbance
기간: Baseline, 6 weeks, and 10 weeks
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Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in family communication
기간: Baseline, 6 weeks, and 10 weeks
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Family communication will be assessed using the Social Constraint Scale
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in interpersonal closeness
기간: Baseline, 6 weeks, and 10 weeks
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Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in acceptance of illness
기간: Baseline, 6 weeks, and 10 weeks
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Acceptance of illness will be assessed using the PEACE Scale.
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Baseline, 6 weeks, and 10 weeks
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Change from baseline in mindfulness
기간: Baseline, 6 weeks, and 10 weeks
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Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.
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Baseline, 6 weeks, and 10 weeks
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Distress Thermometer
기간: Baseline, 6 weeks, and 10 weeks
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Distress will be assessed using the Distress Thermometer.
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Baseline, 6 weeks, and 10 weeks
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Intervention satisfaction and helpfulness
기간: 6 weeks
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Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only).
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6 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Shelley A Johns, PsyD, Indiana University School of Medicine
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 (실제)
2017년 5월 9일
기본 완료 (실제)
2017년 12월 11일
연구 완료 (실제)
2017년 12월 11일
연구 등록 날짜
최초 제출
2017년 8월 16일
QC 기준을 충족하는 최초 제출
2017년 8월 17일
처음 게시됨 (실제)
2017년 8월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 8월 10일
마지막으로 확인됨
2020년 8월 1일
추가 정보
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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