Background
Methods/design
Design
Partners
Physicians | Role in the study | Center/department |
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Dr Elodie CRÉTEL-DURAND | Coordinating investigator. | Marseilles’ University Hospital (AP-HM), Onco-Geriatic Transversal Unit (UTOG), Intern medicine and therapeutic geriatry Department, UCOG PACA-West, Marseille |
Dr Laurent GREILLER | Principal investigator. | Marseilles’ University Hospital (AP-HM), Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille |
Pr Patrick VILLANI | Associated investigator. | Marseilles’ University Hospital (AP-HM), Intern medicine and therapeutic geriatry Department, Marseille |
Dr Anne-Laure COUDERC | Associated investigator. | Marseilles’ University Hospital (AP-HM), Onco-Geriatic Transversal Unit, Intern medicine and therapeutic geriatry Department, UCOG PACA-West, Marseille |
Pr Fabrice BARLESI | Associated investigator. | Marseilles’ University Hospital (AP-HM), Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille |
Dr Marie-Eve GARCIA | Associated investigator. | Marseilles’ University Hospital (AP-HM), Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille |
Dr Clothilde DE LEQUESNE | Associated investigator. | Marseilles’ University Hospital (AP-HM), Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille |
Dr Marjorie BACHIUCHKA | Associated investigator. | Marseilles’ University Hospital (AP-HM), Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille |
Pr Laetitia DAHAN | Associated investigator. | Marseilles’ University Hospital (AP-HM), Digestive Oncology Department, Marseille |
Pr Jean-François SEITZ | Associated investigator. | Marseilles’ University Hospital (AP-HM), Digestive Oncology Department, Marseille |
Dr Emmanuelle NORGUET-MONEREAU | Associated investigator. | Marseilles’ University Hospital (AP-HM), Digestive Oncology Department, Marseille |
Dr Maud CECILE | Principal Investigator. | Paoli Calmette Institute, Department of Medical Oncology, UCOG PACA-West, Marseille |
Dr Frédérique ROUSSEAU-EXTRA | Associated Investigator. | Paoli Calmette Institute, Department of Medical Oncology, UCOG PACA-West, Marseille |
Dr Cécile BRATICEVIC | Associated Investigator. | Paoli Calmette Institute, Department of Medical Oncology, UCOG PACA-West, Marseille |
Dr Louis TASSY | Associated Investigator. | Paoli Calmette Institute, Department of Medical Oncology, Marseille |
Dr Hervé LE CAER | Principal Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Françoise LE CAER | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Gwenaëlle LE GRAFF | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Hélène LE HÔ | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Christine PIROT | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr AnnAïck PESTEL | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Corine HAUCHART | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Jean-Bernard DELOBEL | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Corine ALLEAUME | Associated Investigator. | Yves Le Foll hospital center, Saint Brieuc |
Dr Frédérique RETORNAZ | Principal Investigator. | Centre Gérontologique Dépatemental, UCOG PACA-West, Marseille |
Dr Margaux VIEILLARD | Associated Investigator. | Centre Gérontologique Dépatemental, Marseille |
Dr Chantal BUTAUD | Principal Investigator. | CHITS Sainte Musse Hospital, Mobile Geriatric Care Unit, UCOG PACA-West, Toulon |
Dr Pierre GUILLET | Associated Investigator. | CHITS Sainte Musse Hospital, Oncology-Hematology Department, Toulon |
Dr Sylvie KIRSCHER | Principal Investigator. | Saint Catherine Institute, Medical Oncology Department, UCOG PACA-West, Avignon |
Dr Philippe DEBOURDEAU | Associated Investigator. | Saint Catherine Institute, Avignon |
Dr Rania BOUSTANY | Associated Investigator. | Saint Catherine Institute, Oncology-Radiotherapy Department, Avignon |
Dr Olivier GUILLEM | Principal Investigator. | South Alpes Intercomunal Hospital Center (CHICAS), Oncogeriatry Department, UCOG PACA-West, Gap |
Dr Corrine GAILLARD | Associated Investigator. | South Alpes Intercomunal Hospital Center (CHICAS), Medical geriatry Department, Gap |
Dr Sophie NAHON | Principal Investigator. | Pays d’Aix Hospital center, Hemato-Oncology Department, UCOG PACA-West, Aix-en-Provence |
Dr Laure POUDENS | Associated Investigator. | Pays d’Aix Hospital center, Mobile Geriatric care Team, UCOG PACA-West, Aix-en-Provence |
Dr Sandrine TOURNIER | Principal Investigator. | Saint Jospeh Hospital, Geriatry Department, UCOG PACA-West, Marseilles |
Dr Eve YOUSSOF | Associated Investigator. | Saint Joseph Hospital, Oncology Day Hospital, Marseille |
Dr Christelle BASTHISTE-PELE | Associated Investigator. | Saint Joseph Hospital, Oncology Day Hospital, Marseille |
Dr Jean-Baptiste PAOLI | Associated Investigator. | Saint Joseph Hospital, Oncology Day Hospital, Marseille |
Dr Hervé PERRIER | Associated Investigator. | Saint Joseph Hospital, Oncology Day Hospital, Marseille |
Dr Cyril FOA | Associated Investigator. | Saint Joseph Hospital, Oncology Day Hospital, Marseille |
Dr Rabia BOULAHSSASS | Principal Investigator. | Nice University Hospital, UCOG PACA-East, Nice |
Dr Marine SANCHEZ | Associated Investigator. | Nice University Hospital, Nice |
Multidisciplinary team | ||
Pr Pascal AUQUIER | Methodology | Public health, public academic teaching hospital, Marseille |
Dr Karine BAUMSTARCK | Methodology | Clinical research unit, public academic teaching hospital, Marseille |
Dr Emilie NOUGUEREDE | Study Coordinator | Marseilles’ Comprehensive Cancer center (SIRIC), Marseilles’ University Hospital (AP-HM) |
Jean DHORNE | Project Manager | Clinical research and system innovation (DRCI), Marseilles’ University Hospital (AP-HM) |
Steering committee
Participants
Inclusion criteria |
- Patient aged 70 years or older - Socially isolated or at risk of social isolation (m-MOS-SS under 80% [13] and/or isolated patient (caregiver living more than 50 km from the patient) and/or primary caregiver to his/her spouse [the spouse who has a limited autonomy (neurodegenerative disease, cancer, etc.] implying regular medical care for at least 3 months) - G8 score ≤14 - Performance status ≤2 - Autonomous (ADL score ≥4) - Life span >6 months - Metastatic or locally advanced tumor histologically proven from: colon, rectum, pancreas, breast, ovary, lung, superior aerodigestive path, prostate, urothelium - Being treated for first line of chemotherapy or radio-chemotherapy - Patient affiliated to the French care system protection - Informed consent given |
Exclusion criteria |
- Patient aged under 70 years old - Patient who has to be hospitalized straight away - Patient with psychiatric troubles or advanced dementia - Protected adults under guardianship or curatorship - Patients with a second cancer except for cervical cancer - Patients unable to complete the QoL questionnaire without help - Patient to be directed immediately into a rehabilitation and recuperative care service to benefit from treatment. |
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An m-MOS-SS score under 80%: auto-questionnaire composed of 8 items derived for the Medical Outcomes Study Social Support Survey (MOS-SS) and validated for elderly patients treated for cancer pathologies [13]
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And/or isolated patient, living alone with a primary caregiver (designated by the patient), living more than 50 km from the patient’s home
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And/or patient him(her)self being primary caregiver to a spouse whose autonomy is limited (neurodegenerative disease, cancer, etc.), implying regular medical care for at least 3 months
Groups
Control group: usual care management
Experimental group
Recruitment and follow-up
Screening, inclusion, and randomization (t –1 )
Follow-up and data collection (T0 to T7)
Inclusion | Intervention implementation | 6 months intervention | Close-out | |||||||||||||||
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t-1
| T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | ||||||||||
Exposed (E) or Non-exposed (NE) patients | E | NE | E | NE | E | NE | E | NE | E | NE | E | NE | E | NE | E | NE | E | NE |
Enrollment: | ||||||||||||||||||
Initial oncologist consult (geriatric frailties screening G8 scale) | X | X | ||||||||||||||||
Comprehensive Geriatric Assessment (CGA) (social isolation evaluation, eligibility screening) | X | X | ||||||||||||||||
Informed consent | X | X | ||||||||||||||||
Allocation | X | X | ||||||||||||||||
Social worker initial evaluation (SE) | SE | SE | ||||||||||||||||
Domotic pack installation | X | X | ||||||||||||||||
Intervention: | ||||||||||||||||||
Oncologist consult and treatment | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Social worker telephone follow-up (TF) | TF | TF | TF | TF | TF | TF | ||||||||||||
Domotic and remote assistance care package | X | X | X | X | X | X | ||||||||||||
Assessments: | ||||||||||||||||||
Autonomy (ADL + IADL); Nutritional and functional status evaluation | X | X | X | X | X | X | ||||||||||||
Tumor response (RECIST 1.1) | X | X | X | X | X | X | ||||||||||||
Dose response-intensity (Bonadonna criteria) | X | X | X | X | ||||||||||||||
Treatment toxicity (NCI-CTCAE) | X | X | X | X | X | X | X | X | X | X | X | X | ||||||
QoL evaluation (EORTC QLQ-C30 + ELD 14 module) | X | X | X | X | X | X | ||||||||||||
Survival | X | X |
Endpoints/evaluation criteria
Primary endpoint
Secondary endpoints
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EORTC QLQ-C30 at 6 and 12 months post-randomization.
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The EORTC QLQ-ELD14, an additional module for measuring QoL in patients aged ≥70 years in oncology studies, was added to the core questionnaire and comprises 14 questions assessing elderly-specific needs analyzed on five scales (mobility, worries about others, future worries, maintaining purpose, and illness burden) and two single items (joint stiffness and family support) [17]. High scores indicate a high level of problems.
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Time to treatment failure will be assessed as the delay between inclusion and treatment failure whatever may the cause be. Treatment failure will be assessed as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria [18].
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Toxicity at the end of the treatment will be evaluated using the NCI-CTCAE (National Cancer Institute – Common Terminology Criteria For Adverse events, version 4.0)
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Compliance will be evaluated by observance of the oncologic treatment defined by the following parameters: the treatment completion in terms of number of chemotherapy cycles received out the number intended, will be compared between the two groups; the dose response-intensity (DRI) defined by the relative amount of treatment delivered by time units in relation to a standard treatment chosen arbitrarily or in relation to a combined treatment. A DRI <85% indicates a significant diminution according to the Bonadonna criteria [19].
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Autonomy will be assessed by the Katz and Lawton scales respectively measuring the patient’s ability to perform activities of daily living (ADL Scale) and Instrumental Activities of Daily Living (IADL Scale) at 3 and 6 months. Patients unable to perform at least one activity will be considered as dependent either in daily living activities or instrumental activities, except for urinary incontinence. Patients enrolled in the study must present an ADL score higher or equal to 4 (out of 6). Decline in autonomy will be assessed as the number of activities at 3 and 6 months compared to the baseline.
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Overall survival will be calculated as a function of time between inclusion and authenticated death of the patient (death certificate or hospital reporting) at 6 and 12 months.
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Progression-free survival will be calculated as a function of time between inclusion and authenticated cancer progression according to the RECIST 1.1 criteria [18] at 6 and 12 months.
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Social isolation will be measured by the m-MOS-SS (modified Medical Outcomes Study Social Support Survey) scale and the following items: housing, living place (urban, suburban, or rural), marital status, lifestyle (single or family with children or spouse), resource person and caregiver geographical distance with children or the primary caregiver, medical and social, and recreational pursuits, desire for life, and motivation for treatment.
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The number of unplanned re-hospitalizations will also be documented.