ElderlyPREDOMOSNCT02829762
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
A study testing Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance in people with Elderly and Locally Advanced or Metastatic Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly, Locally Advanced or Metastatic Cancer
- What is being tested?
- Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2018to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Aurélie DAUMAS, Dr, 04 91 38 87 19 ext. +33, aurelie.daumas@ap-hm.fr
Anne-Laure COUDERC, 04 91 34 45 30 ext. +33, anne-laure.couderc@ap-hm.fr
About this study
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
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.
Read the 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.
- Conditions
- Elderly, Locally Advanced or Metastatic Cancer
- Being tested
- Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance
- Keywords
- isolated, at risk of isolation, patients
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (11)
Time to failure of first line of treatment
Time between inclusion and treatment failure, whatever the cause
Measured: 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).
Measured: 12 months
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
Treatment compliance
Measured: 12 months
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
Measured: 3 months and 6 months
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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
Measured: 12 months
Measure of the "global health score" to assess the quality of life at first line of treatment
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start26 Feb 2018
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829762
- Sponsor's protocol ID
- 2015-44
- Other IDs
- 2015-A01976-43
- Acronym
- PREDOMOS
- Status last verified
- Nov 2018
- First submitted
- 29 Jun 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30646923Cretel-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.
PubMed 28403911
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02829762
- Acronym / sponsor ID
- PREDOMOS / 2015-44
- Conditions
- Elderly, Locally Advanced or Metastatic Cancer
- Keywords
- isolated, at risk of isolation, patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm PS-DR | Experimental | Other: Program of geriatric and Social intervention associated techniques of Domotic and Remote assistanceThe 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). |
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 70 years
- G8 score ≤ 14.
- WHO score ≤2
- Having an ADL score ≥ 4 (Katz scale).
- Having an MMSE score > 24
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program of geriatric and Social intervention associated techniques of Domotic and Remote assistanceImplementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance | Other | Interventional arm PS-DR |
Primary outcome
Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start
Time frame: 3 months
The "global health" score will constitute the main judgment criteria
11 secondary outcomes
Time to failure of first line of treatment
Time frame: From date of inclusion until treatment failure, up to 6 months
First line of treatment toxicity at the end
Time frame: 12 months
Assessment of the number of chemotherapies received by patient compared to the number of prescribed chemotherapies
Time frame: 12 months
Assessment of the patient dependency level determined by evaluating the Daily living activities (ADL) with the Katz scale
Time frame: 3 months and 6 months
Assessment of the patient dependency level determined by evaluating the- instrumental activities across Lawton scale
Time frame: 3 months and 6 months
Nutritional assessment at 3 months and 6 months
Time frame: 3 months and 6 months
Functional assessment at 3 months and 6 months
Time frame: 3 months and 6 months
Overall Survival defined as the time between chemotherapy start and death
Time frame: 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 frame: up to 12 months
Social isolation
Time frame: 12 months
Measure of the "global health score" to assess the quality of life at first line of treatment
Time frame: 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 30646923Couderc 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.
- Derived from this study: PubMed 28403911Cretel-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier ARNAUD study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance in people with Elderly and Locally Advanced or Metastatic Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie DAUMAS, Dr (04 91 38 87 19 ext. +33, aurelie.daumas@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the quality of life by EORTC-QLQc30 scale 3 months after treatment start (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829762, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.