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

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.

Study Overview

• Status: Unknown
• Conditions: Elderly; Locally Advanced or Metastatic Cancer
• Intervention / Treatment: Other: Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance

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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Aurélie DAUMAS, Dr; Phone Number: +33 04 91 38 87 19; Email: aurelie.daumas@ap-hm.fr
    • Contact: Anne-Laure COUDERC; Phone Number: +33 04 91 34 45 30; Email: anne-laure.couderc@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance; Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to failure of first line of treatment	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	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	Treatment compliance	12 months
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale		3 months and 6 months
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale		3 months and 6 months
Nutritional assessment at 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	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	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.	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	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		3 months and 6 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: patients; isolated; at risk of isolation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: 2015-44; 2015-A01976-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No