Quality of Life Interventions During Cervical Cancer Treatment
2021년 5월 25일 업데이트: Susan Lutgendorf, University of Iowa
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
연구 개요
상태
완전한
정황
상세 설명
Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression.
This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.
연구 유형
중재적
등록 (실제)
60
단계
- 해당 없음
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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.
Exclusion Criteria:
- Greater than Stage IVa cervical cancer
- Metastatic or recurrent cervical cancer
- Patients receiving only chemotherapy or only radiation therapy
- History of cancer of any site
- History of a transplant
- Diagnosed with any immunosupressive disorder (HIV, AIDS).
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 |
|---|---|
|
실험적: Relaxation training following daily radiation
All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants.
Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery
|
Muscle relaxation training
다른 이름들:
Subjects in all groups will give 4 blood samples during the study
다른 이름들:
|
|
실험적: Healing touch therapy following daily radiation
All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants.
Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.
|
Subjects in all groups will give 4 blood samples during the study
다른 이름들:
Healing Touch (HT) therapy
다른 이름들:
|
|
활성 비교기: No intervention
The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.
|
Subjects in all groups will give 4 blood samples during the study
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in natural killer cell cytotoxicity (NKCC)
기간: 6 weeks
|
Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay. |
6 weeks
|
|
Number of chemoradiation-related toxicities
기간: 6 weeks
|
Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0
|
6 weeks
|
|
Number of days of treatment delay due to chemoradiation-related toxicities
기간: 6 weeks
|
Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care
|
6 weeks
|
|
Change in participant reports of depression
기간: 6 weeks
|
Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)
|
6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in participant reports of anxiety
기간: 6 weeks
|
Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)
|
6 weeks
|
|
Change in white blood cell counts
기간: 6 weeks
|
Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. |
6 weeks
|
|
Change in red blood cell counts
기간: 6 weeks
|
Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.
|
6 weeks
|
|
Change in participant reports of quality of life
기간: 6 weeks
|
Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT).
Higher scores indicate better quality of life.
Range= (0-136).
|
6 weeks
|
|
Change in participant reports of fatigue
기간: 6 weeks
|
Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI).
Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.
|
6 weeks
|
|
Change in metabolomic measures
기간: 6 weeks
|
Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care.
Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS).
The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc.
For any specific metabolite, higher levels indicates greater presence of the metabolite.
|
6 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Susan Lutgendorf, PhD, University of Iowa
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
- Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.
- Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.
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)
2001년 6월 4일
기본 완료 (실제)
2008년 3월 15일
연구 완료 (실제)
2014년 7월 1일
연구 등록 날짜
최초 제출
2021년 5월 20일
QC 기준을 충족하는 최초 제출
2021년 5월 25일
처음 게시됨 (실제)
2021년 5월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 25일
마지막으로 확인됨
2021년 5월 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. .