Trials Sponsors Conditions Drugs Pricing

Conditions

Elderly Locally Advanced or Metastatic Cancer

Keywords

isolatedat risk of isolationpatients

Outcome Measures

Primary Outcomes (1)

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 Outcomes (11)

Time to failure of first line of treatment
From date of inclusion until treatment failure, up to 6 months
First line of treatment toxicity at the end
12 months
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
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
+6 more secondary outcomes

Study Arms (2)

Interventional arm PS-DR

EXPERIMENTAL

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

Reference Arm

NO INTERVENTION

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.

Interventions

Program of geriatric and Social intervention associated techniques of Domotic and Remote assistanceOther

Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance

Interventional arm PS-DR

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age70 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Age ≥ 70 years
G8 score ≤ 14.

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

Aurélie DAUMAS, DrCONTACT04 91 38 87 19 ext. +33 aurelie.daumas@ap-hm.fr

Anne-Laure COUDERCCONTACT04 91 34 45 30 ext. +33 anne-laure.couderc@ap-hm.fr

Related Publications (2)

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.
PMID: 30646923DERIVED
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.
PMID: 28403911

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Jean-Olivier ARNAUD
Assistance Publique Hôpitaux de Marseille
STUDY DIRECTOR

Central Study Contacts

Aurélie DAUMAS, Dr

CONTACT

04 91 38 87 19 aurelie.daumas@ap-hm.fr

Anne-Laure COUDERC

CONTACT

04 91 34 45 30

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 12, 2016

Study Start

February 26, 2018

Actual (reported)

Primary Completion

August 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Interventional arm PS-DR

Reference Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Interventional arm PS-DR

Reference Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations