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

Elderly Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829762
• Other study ID #: 2015-44
• Secondary ID: 2015-A01976-43
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: August 2022

Study information

• Verified date: November 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Aurélie DAUMAS, Dr
• Phone: 04 91 38 87 19
• Email: aurelie.daumas[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Locally Advanced or Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies	Treatment compliance	12 months
Secondary	Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale		3 months and 6 months
Secondary	Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale		3 months and 6 months
Secondary	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
Secondary	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
Secondary	Overall Survival defined as the time between chemotherapy start and death	will be assessed at 6 months and 1 year	up to 12 months
Secondary	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
Secondary	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
Secondary	Measure of the "global health score" to assess the quality of life at first line of treatment		3 months and 6 months