Clinical trial NCT05720910: Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Official title: Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Comorbidities and Coexisting Conditions
Lung Cancer
Colorectal Cancer
Prostate Cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: EUCLID Clinical Trial Platform
name: University of Bordeaux
First posted: 2023-02-09
Enrollment: 720
Sex: ALL
Minimum age (years): 70
Maximum age (years): 130
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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 myPatientSpace adapted for GERONTE 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.

Eligibility criteria: Inclusion Criteria:

- General inclusion criteria

1. Age ≥ 70 years old.
2. New or progressive cancer (breast, lung, colorectal, prostate), histologically proven or strong clinical suspicion, fulfilling the tumor specific criteria.
3. Estimated life expectancy greater than 6 months.
4. At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3).
5. Patients must be willing and able to comply with study procedures.
6. Voluntarily signed and dated written informed consents prior to any study specific procedure.
7. QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion.
8. 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
9. 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.
10. 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 and/or immunotherapy. 10.2. Metastatic colorectal cancer (M1):
    * The cancer specialist considers\* first or second 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.
11. 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:

1. Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.
2. Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.
3. Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol.
4. Patient already included in this study.

Primary outcomes:
measure: Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life of elders cancer patients
timeFrame: baseline 3, 9 and 12 months
measure: Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
timeFrame: baseline 3, 9 and 12 months
measure: Survival
timeFrame: at 12 months
measure: Patient frailty
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Patient autonomy,
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Patient weight evolution
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Patient anxiety
timeFrame: baseline, 3, 6, 9 and 12 months
measure: institutionalisation
timeFrame: 6 and 12 months
measure: unscheduled hospitalisations
timeFrame: 6 and 12 months
measure: Cost per life years gained
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Caregiver burden in health, psychological well-being, finances, social life and relationship with patient
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Patient experience of person-centered coordinated care
timeFrame: 6 and 12 months
measure: Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system
timeFrame: 6 and 12 months
measure: GERONTE patient-centered system implementation and usage
timeFrame: 6 months
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Bordeaux
country: France
facility: Institut Bergonié
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Tenon AP-HP
city: Saint-Malo
country: France
facility: Groupe Hospitalier Rance Emeraude
Study officials:
References: