An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.
II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.
SECONDARY OBJECTIVES:
I. To examine changes in DNA repair function before and after a single exercise session.
II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.
III. To examine the effect of the exercise intervention on these measurements.
IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.
OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
After completion of study, patients are followed up for 12 months.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the Armstrong method
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Newly diagnosed, primary, epithelial ovarian cancer
- Have undergone surgical debulking
- Will be treated according to the Armstrong method
- Read and understand English
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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 |
|---|---|
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실험적: Arm I (exercise intervention)
Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity.
Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
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상관 연구
보조 연구
다른 이름들:
보조 연구
Undergo supervised 1-on-1 exercise sessions
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed
기간: 18 weeks
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18 weeks
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Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in body composition
기간: Baseline to 18 weeks
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Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
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Baseline to 18 weeks
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Change in DNA repair function, assessed by host reactivation assays
기간: Before single exercise session to after single exercise session, assessed up to 12 months
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Will be analyzed using paired t-tests
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Before single exercise session to after single exercise session, assessed up to 12 months
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Change in DNA repair function, assessed by host reactivation assays
기간: Baseline to 18 weeks
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Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
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Baseline to 18 weeks
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Change in quality of life, assessed by questionnaires
기간: Baseline to 18 weeks
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Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
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Baseline to 18 weeks
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Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2
기간: Baseline to 18 weeks
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Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
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Baseline to 18 weeks
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Change in treatment satisfaction, assessed by Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General
기간: Baseline to 18 weeks
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Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
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Baseline to 18 weeks
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Clinical outcome follow-up defined as death, cancer recurrence, or new primary cancer
기간: Up to 12 months
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Up to 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jessica Clague DeHart, PhD, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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
기타 연구 ID 번호
- 15388 (기타 식별자: City of Hope Medical Center)
- NCI-2016-01183 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
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