Improving quality of life for elderly cancer patients using integrated care technology
Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients
NA · Institut Bergonié · NCT05720910
This study is testing a new care program using technology to see if it can improve the quality of life for older cancer patients in different hospitals across France.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 70 Years to 130 Years |
| Sex | All |
| Sponsor | Institut Bergonié (other) |
| Drugs / interventions | chemotherapy, immunotherapy, Prednisone |
| Locations | 10 sites (Bayonne and 9 other locations) |
| Trial ID | NCT05720910 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the GERONTE ICT-based integrated care pathway aimed at enhancing the quality of life for elderly patients with various types of cancer. It employs a stepped wedge randomized controlled design across eight hospitals in France, where each site implements the intervention in a staggered manner over two-month periods. The primary endpoint is the assessment of quality of life using the EORTC QLQ-C30 questionnaire at six months post-implementation. The trial includes a diverse patient population to ensure representative data across different cancer types.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older with new or progressive non-metastatic breast, lung, colorectal, or prostate cancer and at least one moderate to severe comorbidity.
Not a fit: Patients with a life expectancy of less than six months or those without significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for elderly cancer patients.
How similar studies have performed: Other studies have shown promise in improving patient outcomes through integrated care pathways, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bayonne and 9 other locations
- Centre Hospitalier de la Côte Basque — Bayonne, France (RECRUITING)
- Institut Bergonié — Bordeaux, France (RECRUITING)
- Centre Hospitalier Départemental Vendée — La Roche-sur-Yon, France (RECRUITING)
- Centre Léon Bérard — Lyon, France (RECRUITING)
- Centre Azuréen de Cancérologie — Mougins, France (RECRUITING)
- Centre Hospitalier Universitaire de Nice — Nice, France (RECRUITING)
- Centre Antoine Lacassagne — Nice, France (RECRUITING)
- Hôpital Tenon AP-HP — Paris, France (RECRUITING)
- Centre Eugène Marquis — Rennes, France (RECRUITING)
- Groupe Hospitalier Rance Emeraude — St-Malo, France (RECRUITING)
Study contacts
- Study coordinator: Pierre-Louis SOUBEYRAN, MD, PhD
- Email: P.Soubeyran@bordeaux.unicancer.fr
- Phone: +33 5 56 33 33 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer, Colorectal Cancer, Prostate Cancer