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

NCT02829762 | Unknown

• 2 other identifiers: 2015-442015-A01976-43
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Locally Advanced or Metastatic Cancer

Keywords

isolated; at risk of isolation; patients

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

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 assistance OTHER

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

Interventional arm PS-DR

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

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: 30646923 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological 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; anne-laure.couderc@ap-hm.fr

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
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

FR (1)