Streamlined Geriatric and Oncological Evaluation Based On IC Technology

Breast Cancer Clinical Trial

— FRONE  

Official title:

Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05720910
• Other study ID #: IB2022-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: January 2026

Study information

• Verified date: January 2023
• Source: Institut Bergonié
• Contact: kinkle VODJOGBE
• Phone: 05.56.33.33.33 (poste 6184)
• Email: frone[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 720
• Est. completion date: January 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 130 Years

Eligibility

Inclusion Criteria:

• General inclusion criteria

1. Age = 70 years old.

2. New or progressive cancer (breast, lung, colorectal, prostate) 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. 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.

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Comorbidities and Coexisting Conditions
• Lung Cancer
• Prostate Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Institut Bergonié	EUCLID Clinical Trial Platform, University of Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	baseline 3, 9 and 12 months
Secondary	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.	baseline 3, 9 and 12 months
Secondary	Survival	Overall survival and progression-free survival	at 12 months
Secondary	Patient frailty	Score of the Clinical frailty scale	baseline, 3, 6, 9 and 12 months
Secondary	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	baseline, 3, 6, 9 and 12 months
Secondary	Patient weight evolution	Weight in Kilograms	baseline, 3, 6, 9 and 12 months
Secondary	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.	baseline, 3, 6, 9 and 12 months
Secondary	institutionalisation	Proportion of patient institutionalised per participants	6 and 12 months
Secondary	unscheduled hospitalisations	Proportion of unscheduled hospitalisations per participants	6 and 12 months
Secondary	Cost per life years gained	using utility assessed through normalised scores of EQ-5D-5L questionnaire	baseline, 3, 6, 9 and 12 months
Secondary	Caregiver burden in health, psychological well-being, finances, social life and relationship with patient	Zarit Burden Interview	baseline, 3, 6, 9 and 12 months
Secondary	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.	6 and 12 months
Secondary	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.	6 and 12 months
Secondary	GERONTE patient-centered system implementation and usage	use of the HolisTM GV software measures, for instance: number and frequency of connections.	6 months