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)
Primary Purpose
Elderly, Locally Advanced or Metastatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance
Sponsored by
About this trial
This is an interventional supportive care trial for Elderly focused on measuring isolated, at risk of isolation, patients
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional arm PS-DR
Reference Arm
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
The "global health" score will constitute the main judgment criteria
Secondary Outcome Measures
Time to failure of first line of treatment
Time between inclusion and treatment failure, whatever the cause
First line of treatment toxicity at the end
Measured by Toxicity scale NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events, version 4.0).
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
Treatment compliance
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
Nutritional assessment at 3 months and 6 months
Body mass index (BMI) is the ratio of weight to height in cm squared.
Functional assessment at 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).
Overall Survival defined as the time between chemotherapy start and death
will be assessed at 6 months and 1 year
Progression free Survival defined as the time between treatment start and the date of first documented progression or death, whatever the cause.
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).
Social isolation
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
Measure of the "global health score" to assess the quality of life at first line of treatment
Full Information
NCT ID
NCT02829762
First Posted
June 29, 2016
Last Updated
November 26, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02829762
Brief Title
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
Acronym
PREDOMOS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Locally Advanced or Metastatic Cancer
Keywords
isolated, at risk of isolation, patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional arm PS-DR
Arm Type
Experimental
Arm Description
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).
Arm Title
Reference Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance
Intervention Description
Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance
Primary Outcome Measure Information:
Title
Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
Description
The "global health" score will constitute the main judgment criteria
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time to failure of first line of treatment
Description
Time between inclusion and treatment failure, whatever the cause
Time Frame
From date of inclusion until treatment failure, up to 6 months
Title
First line of treatment toxicity at the end
Description
Measured by Toxicity scale NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events, version 4.0).
Time Frame
12 months
Title
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
Description
Treatment compliance
Time Frame
12 months
Title
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
Time Frame
3 months and 6 months
Title
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
Time Frame
3 months and 6 months
Title
Nutritional assessment at 3 months and 6 months
Description
Body mass index (BMI) is the ratio of weight to height in cm squared.
Time Frame
3 months and 6 months
Title
Functional assessment at 3 months and 6 months
Description
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).
Time Frame
3 months and 6 months
Title
Overall Survival defined as the time between chemotherapy start and death
Description
will be assessed at 6 months and 1 year
Time Frame
up to 12 months
Title
Progression free Survival defined as the time between treatment start and the date of first documented progression or death, whatever the cause.
Description
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).
Time Frame
up to 12 months
Title
Social isolation
Description
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
Time Frame
12 months
Title
Measure of the "global health score" to assess the quality of life at first line of treatment
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie DAUMAS, Dr
Phone
04 91 38 87 19
Ext
+33
Email
aurelie.daumas@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure COUDERC
Phone
04 91 34 45 30
Email
anne-laure.couderc@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie DAUMAS, Dr
Phone
04 91 38 87 19
Ext
+33
Email
aurelie.daumas@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Anne-Laure COUDERC
Phone
04 91 34 45 30
Ext
+33
Email
anne-laure.couderc@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30646923
Citation
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.
Results Reference
derived
PubMed Identifier
28403911
Citation
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.
Results Reference
derived
Learn more about this trial
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
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