A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)
The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.
Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.
연구 개요
상세 설명
Introduction: A comprehensive geriatric assessment (CGA) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. However, few randomized controlled trials (RCTs) have been completed showing the evidence.
OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer METHODS -
A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. The co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.
Recruitment has been completed November 2015
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ontario
-
Toronto, Ontario, 캐나다, M5T 2M9
- Princess Margaret Cancer Centre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis of advanced (stage 2, 3 or 4) Gastrointestinal, Genitourinary, or breast cancer
- Referred for first-line chemotherapy
- Ability to speak English
- Physician estimated life expectancy >6 months
- An Eastern Oncology Group Collaborative (ECOG) Performance Score of 0-2
- Ability to provide informed consent
Exclusion Criteria:
- Previous chemotherapy for current stage of disease
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: GA and Integrated Care Plan
Participants allocated to the intervention group will be seen in the geriatric oncology clinic where they will be assessed using a geriatric assessment.
Based on the issues identified in the geriatric assessment, a care plan will be developed with the participant to address the issues.
|
The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment.
The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?
|
|
간섭 없음: Standard oncology care
Participants randomized to standard oncology care will receive usual care from their oncology team.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of life
기간: 6 months
|
We will measure quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core version 30 items (EORTC QLQ C30)
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire
기간: 6 months
|
The treating oncologist will be asked to indicate the cancer treatment plan prior to receiving the geriatric assessment results using a survey previously used in the study of Dr. Alibhai et al (Am J Clin Oncol. 2012 Aug;35(4):322-8.). After the GA the results will be send to the treating oncologist and after the physician will be asked to indicate whether or not and if yes how he/she modified the treatment plan based on the GA results |
6 months
|
|
Functional status
기간: 6 months
|
We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Martine Puts, PhD, University of Toronto
간행물 및 유용한 링크
일반 간행물
- Sattar S, Alibhai SMH, Brennenstuhl S, Kulik M, MacDonald ME, McWatters K, Lee K, Jang R, Amir E, Krzyzanowska MK, Joshua AM, Monette J, Wan-Chow-Wah D, Puts MTE. Health status, emergency department visits, and oncologists' feedback: An analysis of secondary endpoints from a randomized phase II geriatric assessment trial. J Geriatr Oncol. 2019 Jan;10(1):169-174. doi: 10.1016/j.jgo.2018.06.014. Epub 2018 Jul 21.
- Puts MTE, Sattar S, Kulik M, MacDonald ME, McWatters K, Lee K, Brennenstuhl S, Jang R, Amir E, Krzyzanowska MK, Joshua AM, Monette J, Wan-Chow-Wah D, Alibhai SMH. A randomized phase II trial of geriatric assessment and management for older cancer patients. Support Care Cancer. 2018 Jan;26(1):109-117. doi: 10.1007/s00520-017-3820-7. Epub 2017 Jul 25.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 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. .