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Streamlined Geriatric and Oncological Evaluation Based On IC Technology (FRONE)

Primary Purpose

Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GERONTE
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

70 Years - 130 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - General inclusion criteria Age ≥ 70 years old. New or progressive cancer (breast, lung, colorectal, prostate) fulfilling the tumor specific criteria. Estimated life expectancy greater than 6 months. At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3). Patients must be willing and able to comply with study procedures. Voluntarily signed and dated written informed consents prior to any study specific procedure. QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion. Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public health). Tumor specific inclusion criteria Specific inclusion criteria for breast cancer: 9.1. Non-metastatic breast cancer (M0): - No prior treatment for the current breast cancer. - All 3 criteria required: o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3; The cancer specialist considers* surgery; The cancer specialist considers* radiotherapy and/or chemotherapy. 9.2. Metastatic breast cancer (M1): Both criteria required: The cancer specialist considers* chemotherapy or PARP-inhibitors or mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6 inhibitors is allowed; The patient received maximum 1 prior line of chemotherapy for metastatic disease. 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. Specific inclusion criteria for colorectal cancer: 10.1. Non-metastatic colorectal cancer (M0): - No prior therapy for the current tumor in the recruiting hospital At least one of the 3 criteria required: o The cancer specialist considers* surgery; The cancer specialist considers* radiotherapy; The cancer specialist considers* chemotherapy. 10.2. Metastatic colorectal cancer (M1): The cancer specialist considers* first line systemic therapy and/or radiotherapy (+/- surgery). No previous chemotherapy allowed except adjuvant/perioperative chemotherapy stopped for more than 12 months. 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. Specific inclusion criteria for lung cancer: 11.1. Non-metastatic lung cancer (M0): No prior therapy for the current tumor in the recruiting hospital At least one of the 3 criteria required: The cancer specialist considers* surgery (patients considered for treatment with percutaneous thermoablation alone are not eligible); The cancer specialist considers* radiotherapy (except SBRT); The cancer specialist considers* systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible. 11.2. Metastatic lung cancer (M1): The cancer specialist considers* first or second line systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible. *'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. 12. Specific inclusion criteria for prostate cancer: 12.1. Non-metastatic prostate cancer (M0): one of the following: First diagnosis M0 prostate cancer (no therapy received yet for prostate cancer): at least one of the 2 criteria required: o The cancer specialist considers* radiotherapy; o The cancer specialist considers* hormone therapy (ADT +/- combination Abiraterone and Prednisone). Salvage treatment M0 prostate cancer (received prior surgery at least 6 months before): o The cancer specialist considers* radiotherapy (+/- ADT) Non-metastatic castration resistant prostate cancer: The cancer specialist considers* treatment intensification (ADT + Enzalutamide or Apalutamide or Darolutamide). 12.2. Metastatic prostate cancer (M1): - The cancer specialist considers* treatment with Abiraterone or Enzalutamide or Apalutamide, or Docetaxel or Cabazitaxel or PARP-inhibitors or Lutetium PSMA. *'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. Exclusion Criteria: Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures. Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial. Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol. Patient already included in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    GERONTE

    CONTROL ARM

    Arm Description

    The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway;

    Patients included in the control arm will be managed according to the standard of care.

    Outcomes

    Primary Outcome Measures

    Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
    Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion: Normalised global health status score Normalised score of the physical functioning scale Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.

    Secondary Outcome Measures

    Quality of life of elders cancer patients
    Scores of the quality of life questionnaire for elderly cancer patients.(QLQ-ELD14). The minimum value is 14 and the maximum value is 40, and higher scores mean a worse result.
    Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
    The quality of life questionnaire (QLQ-C30) scores. The minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
    Survival
    Overall survival and progression-free survival
    Patient frailty
    Score of the Clinical frailty scale
    Patient autonomy,
    Dependence score of the Activities of Daily Living scale (ADL); Proportion of patients living at home; Number of completed chair stands in 30 seconds
    Patient weight evolution
    Weight in Kilograms
    Patient anxiety
    Score of Hospital Anxiety and Depression (HAD) scale. The minimum value is 0 and the maximum value is 21, and higher scores mean a worse result.
    institutionalisation
    Proportion of patient institutionalised per participants
    unscheduled hospitalisations
    Proportion of unscheduled hospitalisations per participants
    Cost per life years gained
    using utility assessed through normalised scores of EQ-5D-5L questionnaire
    Caregiver burden in health, psychological well-being, finances, social life and relationship with patient
    Zarit Burden Interview
    Patient experience of person-centered coordinated care
    Person-Centered Coordinated Care Experience Questionnaire (P3CEQ)The minimum value is 0 and the maximum value is 45, and higher scores mean a better result.
    Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system
    Score derived from the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps using the Patient version for patient satisfaction and the provider version for physician and health-professional.The minimum value is 0 and the maximum value is 126, and higher scores mean a better result.
    GERONTE patient-centered system implementation and usage
    use of the HolisTM GV software measures, for instance: number and frequency of connections.

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    January 31, 2023
    Sponsor
    Institut Bergonié
    Collaborators
    EUCLID Clinical Trial Platform, University of Bordeaux
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05720910
    Brief Title
    Streamlined Geriatric and Oncological Evaluation Based On IC Technology
    Acronym
    FRONE
    Official Title
    Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Bergonié
    Collaborators
    EUCLID Clinical Trial Platform, University of Bordeaux

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France. Study design is a stepped wedge randomised controlled trial. Clusters will be participating hospitals, comprising eight investigating sites in total (Figure 2). This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. The primary endpoint is the Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire at 6 months after GERONTE implementation. It has 3 sub-scores that will be analysed independently, with alpha risk adjustment.
    Detailed Description
    This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. A total of 10 patients by step are to be included in each center; these 10 patients must be regularly included along the 2-month period of each step. If 10 patients are already included before the end of the 2 months' step period, the center has to stop the inclusions till the beginning of the subsequent step. If a center, near to the end of a step, is far from reaching of the 10 patients' inclusion, it must increase the speed of its inclusions to be as close as possible of 10 patients included at the end of the step. In each center, patient sample has to be representative of type of cancer managed in the center, along the trial duration. The repartition of cancer types must be homogeneous along the steps and during the trial duration. All participating investigating sites will have study collaborators in charge of organizing intervention implementation and data collection. The intervention will be prepared prior to the start of the trial, so that each investigating site can implement it as defined by the randomisation. Each center engaged to participate needs to participate till the end of the trial. A center commitment to participate will be requested before each center involvement to avoid center withdrawal after the start of the trial. Quantitative data regarding the HolisTM GV home app usage will be collected at each step and in each cluster by study collaborators, from the beginning of GERONTE system implementation. Care outcome data (Quality of life, anxiety, autonomy, additional hospitalisation, mortality...) will be collected by local referents at 3, 6, 9 and 12 months after inclusion in GERONTE. The data necessary to calculate the real cost of the intervention, of its implementation and of resource use data of patient management will be continuously collected during follow-up. GERONTE patient-centered system implementation and usage will be collected by the local referents in each center. Qualitative analysis will be performed in each center at GERONTE system implementation and during follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer, Colorectal Cancer, Prostate Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    720 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GERONTE
    Arm Type
    Experimental
    Arm Description
    The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway;
    Arm Title
    CONTROL ARM
    Arm Type
    No Intervention
    Arm Description
    Patients included in the control arm will be managed according to the standard of care.
    Intervention Type
    Other
    Intervention Name(s)
    GERONTE
    Intervention Description
    The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway
    Primary Outcome Measure Information:
    Title
    Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
    Description
    Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion: Normalised global health status score Normalised score of the physical functioning scale Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Quality of life of elders cancer patients
    Description
    Scores of the quality of life questionnaire for elderly cancer patients.(QLQ-ELD14). The minimum value is 14 and the maximum value is 40, and higher scores mean a worse result.
    Time Frame
    baseline 3, 9 and 12 months
    Title
    Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
    Description
    The quality of life questionnaire (QLQ-C30) scores. The minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
    Time Frame
    baseline 3, 9 and 12 months
    Title
    Survival
    Description
    Overall survival and progression-free survival
    Time Frame
    at 12 months
    Title
    Patient frailty
    Description
    Score of the Clinical frailty scale
    Time Frame
    baseline, 3, 6, 9 and 12 months
    Title
    Patient autonomy,
    Description
    Dependence score of the Activities of Daily Living scale (ADL); Proportion of patients living at home; Number of completed chair stands in 30 seconds
    Time Frame
    baseline, 3, 6, 9 and 12 months
    Title
    Patient weight evolution
    Description
    Weight in Kilograms
    Time Frame
    baseline, 3, 6, 9 and 12 months
    Title
    Patient anxiety
    Description
    Score of Hospital Anxiety and Depression (HAD) scale. The minimum value is 0 and the maximum value is 21, and higher scores mean a worse result.
    Time Frame
    baseline, 3, 6, 9 and 12 months
    Title
    institutionalisation
    Description
    Proportion of patient institutionalised per participants
    Time Frame
    6 and 12 months
    Title
    unscheduled hospitalisations
    Description
    Proportion of unscheduled hospitalisations per participants
    Time Frame
    6 and 12 months
    Title
    Cost per life years gained
    Description
    using utility assessed through normalised scores of EQ-5D-5L questionnaire
    Time Frame
    baseline, 3, 6, 9 and 12 months
    Title
    Caregiver burden in health, psychological well-being, finances, social life and relationship with patient
    Description
    Zarit Burden Interview
    Time Frame
    baseline, 3, 6, 9 and 12 months
    Title
    Patient experience of person-centered coordinated care
    Description
    Person-Centered Coordinated Care Experience Questionnaire (P3CEQ)The minimum value is 0 and the maximum value is 45, and higher scores mean a better result.
    Time Frame
    6 and 12 months
    Title
    Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system
    Description
    Score derived from the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps using the Patient version for patient satisfaction and the provider version for physician and health-professional.The minimum value is 0 and the maximum value is 126, and higher scores mean a better result.
    Time Frame
    6 and 12 months
    Title
    GERONTE patient-centered system implementation and usage
    Description
    use of the HolisTM GV software measures, for instance: number and frequency of connections.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    130 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - General inclusion criteria Age ≥ 70 years old. New or progressive cancer (breast, lung, colorectal, prostate) fulfilling the tumor specific criteria. Estimated life expectancy greater than 6 months. At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3). Patients must be willing and able to comply with study procedures. Voluntarily signed and dated written informed consents prior to any study specific procedure. QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion. Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public health). Tumor specific inclusion criteria Specific inclusion criteria for breast cancer: 9.1. Non-metastatic breast cancer (M0): - No prior treatment for the current breast cancer. - All 3 criteria required: o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3; The cancer specialist considers* surgery; The cancer specialist considers* radiotherapy and/or chemotherapy. 9.2. Metastatic breast cancer (M1): Both criteria required: The cancer specialist considers* chemotherapy or PARP-inhibitors or mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6 inhibitors is allowed; The patient received maximum 1 prior line of chemotherapy for metastatic disease. 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. Specific inclusion criteria for colorectal cancer: 10.1. Non-metastatic colorectal cancer (M0): - No prior therapy for the current tumor in the recruiting hospital At least one of the 3 criteria required: o The cancer specialist considers* surgery; The cancer specialist considers* radiotherapy; The cancer specialist considers* chemotherapy. 10.2. Metastatic colorectal cancer (M1): The cancer specialist considers* first line systemic therapy and/or radiotherapy (+/- surgery). No previous chemotherapy allowed except adjuvant/perioperative chemotherapy stopped for more than 12 months. 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. Specific inclusion criteria for lung cancer: 11.1. Non-metastatic lung cancer (M0): No prior therapy for the current tumor in the recruiting hospital At least one of the 3 criteria required: The cancer specialist considers* surgery (patients considered for treatment with percutaneous thermoablation alone are not eligible); The cancer specialist considers* radiotherapy (except SBRT); The cancer specialist considers* systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible. 11.2. Metastatic lung cancer (M1): The cancer specialist considers* first or second line systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible. *'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. 12. Specific inclusion criteria for prostate cancer: 12.1. Non-metastatic prostate cancer (M0): one of the following: First diagnosis M0 prostate cancer (no therapy received yet for prostate cancer): at least one of the 2 criteria required: o The cancer specialist considers* radiotherapy; o The cancer specialist considers* hormone therapy (ADT +/- combination Abiraterone and Prednisone). Salvage treatment M0 prostate cancer (received prior surgery at least 6 months before): o The cancer specialist considers* radiotherapy (+/- ADT) Non-metastatic castration resistant prostate cancer: The cancer specialist considers* treatment intensification (ADT + Enzalutamide or Apalutamide or Darolutamide). 12.2. Metastatic prostate cancer (M1): - The cancer specialist considers* treatment with Abiraterone or Enzalutamide or Apalutamide, or Docetaxel or Cabazitaxel or PARP-inhibitors or Lutetium PSMA. *'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible. Exclusion Criteria: Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures. Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial. Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol. Patient already included in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    kinkle VODJOGBE
    Phone
    05.56.33.33.33 (poste 6184)
    Email
    frone@bordeaux.unicancer.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aurore BARTHOD MALAT
    Phone
    05.47.30.61.81
    Email
    frone@bordeaux.unicancer.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre Soubeyran
    Organizational Affiliation
    Institut Bergonié
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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