Clinical trial NCT02829762: 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
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
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Locally Advanced or Metastatic Cancer
Keywords: isolated
at risk of isolation
patients
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 320
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
timeFrame: 3 months
Secondary outcomes:
measure: Time to failure of first line of treatment
timeFrame: From date of inclusion until treatment failure, up to 6 months
measure: First line of treatment toxicity at the end
timeFrame: 12 months
measure: Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
timeFrame: 12 months
measure: Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
timeFrame: 3 months and 6 months
measure: Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
timeFrame: 3 months and 6 months
measure: Nutritional assessment at 3 months and 6 months
timeFrame: 3 months and 6 months
measure: Functional assessment at 3 months and 6 months
timeFrame: 3 months and 6 months
measure: Overall Survival defined as the time between chemotherapy start and death
timeFrame: up to 12 months
measure: Progression free Survival defined as the time between treatment start and the date of first documented progression or death, whatever the cause.
timeFrame: up to 12 months
measure: Social isolation
timeFrame: 12 months
measure: Measure of the "global health score" to assess the quality of life at first line of treatment
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References:
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.
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.