- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02518308
Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
연구 개요
상태
상세 설명
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53705
- University of Wisconsin Carbone Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of any invasive gynecologic cancer without evidence of disease.
- Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment.
- Able to speak, read and write English
- ECOG Performance Status between 0 and 3
- Subjects must have a phone.
- Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have been present one week prior to eligibility assessment, with worst severity rating greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms
- Expected to continue cancer care at UWCCC for the duration of the study.
Exclusion Criteria:
- Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
- Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
- Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)
- Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
- Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making
- Prisoner or incarcerated
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Arm I (MBSR intervention)
Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7.
The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class.
Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
|
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
다른 이름들:
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간섭 없음: Arm II (control)
Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in anxiety
기간: Baseline to up to 5 months
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Measured by the 8-item anxiety subscale of the PROMIS scale.
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Baseline to up to 5 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in depression
기간: Baseline to up to 5 months
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Measured by PROMIS subscale for depression.
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Baseline to up to 5 months
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Change in fatigue
기간: Baseline to up to 5 months
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Measured by PROMIS subscale for fatigue.
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Baseline to up to 5 months
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Change in sleep disturbance
기간: Baseline to up to 5 months
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Measured by PROMIS subscale for sleep disturbance.
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Baseline to up to 5 months
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Change in sexual function
기간: Baseline to up to 5 months
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Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
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Baseline to up to 5 months
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Change in existential/spiritual distress
기간: Baseline to up to 5 months
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measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
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Baseline to up to 5 months
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Change in cognitive function
기간: Baseline to up to 5 months
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Measured by the NIH Toolbox Assessments
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Baseline to up to 5 months
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Change in cortisol levels
기간: Baseline to up to 5 months
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The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
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Baseline to up to 5 months
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Change in levels of pro-inflammatory cytokines
기간: Baseline to up to 5 months
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The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
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Baseline to up to 5 months
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Change in immune cell phenotypes
기간: Baseline to up to 5 months
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The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
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Baseline to up to 5 months
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Change in NK cell function
기간: Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
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Baseline to up to 5 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ryan Spencer, University of Wisconsin, Madison
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- UW15000
- A532820 (기타 식별자: UW Madison)
- 2015-0549 (기타 식별자: Institutional Review Board)
- SMPH\OBSTET & GYNECOL\OB-GYN (기타 식별자: UW Madison)
- NCI-2015-01263 (레지스트리 식별자: NCI Trial ID)
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. .
Mindfulness-Based Stress Reduction에 대한 임상 시험
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Qazvin University Of Medical Sciences완전한
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Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research Centre (CIMCYC)완전한
-
Qazvin University Of Medical Sciences알려지지 않은
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Oregon Health and Science UniversityMedical Research Foundation, Oregon완전한
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Eric Loucks알려지지 않은신체 활동 | 스트레스, 심리적 | 잠 | 우울 증상 | 다이어트 | 좌식 행동 | 외로움 | 감정 조절 | 마음챙김 | 음주, 청소년미국