Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated (PREDOMOS)
Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated: Randomized, Comparative, Prospective Multi-Centre Study
연구 개요
상태
상세 설명
In France, social isolation and prevalence of cancer increases with the population ageing: it is estimated that in 2050, 1 of 2 cancers will be diagnosed in patients over than 75 years old. Meanwhile, the share of isolated elderly increased from 16 to 24% between 2010 and 2013. It is shown that socially precarious elderly have an increased risk of dying from cancer.
Among the areas of Comprehensive Geriatric Assessment (CGA), social assessment is crucial. It can be assessed by a self-administered 8 items questionnaire, derived from MOS-SS (Medical Outcomes Study Social Support Survey) and validated in the elderly supported for cancer: m-MOS-SS (modified Medical Outcomes Study Social Support).
Once spotted, social isolation can be averted by appropriate measures, provided the intervention of a multidisciplinary team. In this area, the techniques of automation and remote assistance might have an interest. They already demonstrated their impact on falls prevention, addiction, feelings of social isolation and quality of life. However, little is known about the impact of social isolation in elderly patients supported for cancer.
The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Marseille, 프랑스, 13005
- 모병
- Assistance Publique Hopitaux de Marseille
-
연락하다:
- Aurélie DAUMAS, Dr
- 전화번호: +33 04 91 38 87 19
- 이메일: aurelie.daumas@ap-hm.fr
-
연락하다:
- Anne-Laure COUDERC
- 전화번호: +33 04 91 34 45 30
- 이메일: anne-laure.couderc@ap-hm.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 70 years
- G8 score ≤ 14.
- WHO score ≤2
- Having an ADL score ≥ 4 (Katz scale).
- Having an MMSE score > 24
- At risk of social isolation: m-MOS below 80%, and / or the following criteria: patient living alone without close help (<50 km) and / or primary caregiver of the patient's spouse, spouse limited autonomy and / or reached itself a disease (neurodegenerative disease, cancer disease, other) requiring regular hospital treatment for at least 3 months.
- Locally advanced or metastatic cancer or malignant blood disease (except acute leukemia)
- Treated by chemotherapy, new generation hormone therapy, immunotherapy or targeted therapy in first or second line of treatment, with or without radiotherapy
- Life expectancy more than 6 months
- Informed consent signed.
- Patients affiliated to French social security system in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health)
Exclusion Criteria:
- Patients with other cancers
- Patients should be directed immediately into a rehabilitation and recuperative care service to receive treatment or in a palliative care service
- Inability to sign a consent or under guardianship
공부 계획
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: Interventional arm PS-DR
The interventional arm (PS-DR) will include the implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance (in connection with a call center 24h/24).
|
Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance
|
|
간섭 없음: Reference Arm
In the reference arm, patients will have a conventional oncological care, social support measures will be left to the discretion of the clinician and the paramedical team.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
기간: 3 months
|
The "global health" score will constitute the main judgment criteria
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to failure of first line of treatment
기간: From date of inclusion until treatment failure, up to 6 months
|
Time between inclusion and treatment failure, whatever the cause
|
From date of inclusion until treatment failure, up to 6 months
|
|
First line of treatment toxicity at the end
기간: 12 months
|
Measured by Toxicity scale NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events, version 4.0).
|
12 months
|
|
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
기간: 12 months
|
Treatment compliance
|
12 months
|
|
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
기간: 3 months and 6 months
|
3 months and 6 months
|
|
|
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
기간: 3 months and 6 months
|
3 months and 6 months
|
|
|
Nutritional assessment at 3 months and 6 months
기간: 3 months and 6 months
|
Body mass index (BMI) is the ratio of weight to height in cm squared.
|
3 months and 6 months
|
|
Functional assessment at 3 months and 6 months
기간: 3 months and 6 months
|
The unipodal station is to stand on one foot without aid.
A unipodal station less than 5 seconds indicating a high risk of falls (46).
|
3 months and 6 months
|
|
Overall Survival defined as the time between chemotherapy start and death
기간: up to 12 months
|
will be assessed at 6 months and 1 year
|
up to 12 months
|
|
Progression free Survival defined as the time between treatment start and the date of first documented progression or death, whatever the cause.
기간: up to 12 months
|
Time to progression is the time elapsed between the date of treatment start and the occurrence of progression or relapse if a response was observed (response or stabilization). A patient who has not progressed or who did not die at the limit of 1 year will have its censored survival time when tumor enough last evaluation conducted by the deadline of 1 year . The progress will then be defined according to the criteria RECIST1.1 . In case of death , it will be identified if it is related to tumor progression , toxicity or complication of treatment or another cause (non-specific death). |
up to 12 months
|
|
Social isolation
기간: 12 months
|
Social isolation will be measured by the m -MOS questionnaire.
A result < 80% is recognized as the consensus inferior value below which patients are socially isolated position
|
12 months
|
|
Measure of the "global health score" to assess the quality of life at first line of treatment
기간: 3 months and 6 months
|
3 months and 6 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Couderc AL, Nouguerede E, Baumstarck K, Loubiere S, Le Caer H, Guillem O, Rousseau F, Greillier L, Norguet-Monnereau E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Kirscher S, Diaz N, Morando C, Villani P, Auquier P, Daumas A. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial. Trials. 2019 Jan 15;20(1):54. doi: 10.1186/s13063-018-3127-0.
- Cretel-Durand E, Nouguerede E, Le Caer H, Rousseau F, Retornaz F, Guillem O, Couderc AL, Greillier L, Norguet E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Poudens L, Kirscher S, Loubiere S, Diaz N, Dhorne J, Auquier P, Baumstarck K. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial. Trials. 2017 Apr 12;18(1):174. doi: 10.1186/s13063-017-1894-7.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2015-44
- 2015-A01976-43 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .