Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.

NCT05423808 | Withdrawn

• 1 other identifier: s66300
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals.

Conditions

Geriatrics; Medical Oncology; Critical Pathways; Digital Technology

Keywords

Geriatrics; Oncology; Patient-centred care; Technology

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QoL): EORTC QLQ-C30

  Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS). Three derived scores of the QLQ-C30 questionnaire are considered as primary endpoints: * Normalized global health status score of the QLQ-C30 (version 3.0) (score 0-100), * Normalized score of the physical functioning scale of the QLQ-C30 (version 3.0) (score 0-100), * Normalized score of the emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100). A high score for a functional scale represents a high / healthy level of functioning. A high score for the global health status / QoL represents a high QoL.

  QoL at 6 months after study inclusion

Secondary Outcomes (25)

• Quality of Life (QoL): EORTC QLQ-C30

  QoL at 3, 9 and 12 months after study inclusion

• Overall survival

  at 12 months after study inclusion

• Progression-free survival

  at 12 months after study inclusion

• Patient autonomy (1)

  At baseline, 3, 6, 9 and 12 months after study inclusion

• Patient autonomy (2)

  At 6 and 12 months after study inclusion

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will be part of a renewed care pathway supported by digital tools.

Other: Health Professional Consortium; Device: Holis Dashboard - Holis Patient App

Control group

NO INTERVENTION

Patients in the control group will receive standard of care, specific to the hospital where the patient is being treated.

Interventions

Health Professional Consortium OTHER

In the intervention group, the renewed, patient-centred care pathway will be coordinated by the Advanced Practice Nurse (APN) and will be supported by digital technology. The intervention aims to increase the involvement of the patient in the treatment decision process, to provide comprehensive care through the quarterly meeting of all professionals involved in the care of the patient during a Health Professional Consortium (HPC) and to support patient empowerment by supporting self-management by using digital tools.

Intervention group

Holis Dashboard - Holis Patient App DEVICE

In the intervention group, the renewed, patient-centred care pathway will be coordinated by the Advanced Practice Nurse (APN) and will be supported by digital technology. The intervention aims to increase the involvement of the patient in the treatment decision process, to provide comprehensive care through the quarterly meeting of all professionals involved in the care of the patient during a Health Professional Consortium (HPC) and to support patient empowerment by supporting self-management by using digital tools.

Intervention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years old,
• Estimated life expectancy greater than 6 months,
• Patients must be willing and able to comply with study procedures,
• Voluntarily signed and dated written informed consents prior to any study specific procedure,
• No prior treatment for the current breast cancer.
• All 3 criteria required:
• Clinical staging: cT2-3-4 Nany, or cTany N1-2-3,
• The cancer specialist considers\* surgery,
• The cancer specialist considers\* radiotherapy and/or chemotherapy. 8.2. 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.
• No prior therapy for the current tumour in the recruiting hospital.
• At least one of the 3 criteria required:
• \- The cancer specialist considers\* surgery,

You may not qualify if:

• 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.
• Separate list of severe morbidity criteria:
• General
• Two or more unscheduled comorbidity related hospitalisations in the past year (not related to index cancer).
• Having received out-patient care from two more specialties in the past year (not related to index cancer).
• Cardiac
• Any prior symptomatic myocardial infarction.
• Any past valve replacement, percutaneous coronary intervention), percutaneous transluminal coronary angioplasty) or coronary artery bypass graft.
• Congestive heart failure under follow-up by a cardiologist.
• Chronic exertional angina.
• Regular use of anti-anginal medication.
• Left ventricular hypertrophy.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University of Bordeaux: collaborator
• Diakonessenhuis, Utrecht: collaborator
• University of Milan: collaborator
• University College Dublin: collaborator
• Oslo University Hospital: collaborator
• International Society of Geriatric Oncology: collaborator
• Dublin City University: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• General Hospital Groeninge: collaborator
• AZ Sint-Jan AV: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Reinier de Graaf Groep: collaborator
• KU Leuven: collaborator

Study Sites (1)

UZ Gasthuisberg Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

• Hamaker ME, Wildiers H, Ardito V, Arsandaux J, Barthod-Malat A, Davies P, Degol L, Ferrara L, Fourrier C, Kenis C, Kret M, Lalet C, Pelissier SM, O'Hanlon S, Rostoft S, Seghers N, Saillour-Glenisson F, Staines A, Schwimmer C, Thevenet V, Wallet C, Soubeyran P. Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials. J Geriatr Oncol. 2024 May;15(4):101761. doi: 10.1016/j.jgo.2024.101761. Epub 2024 Apr 5.

  PMID: 38581958 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Hans Wildiers, prof. dr.

  Coordinator multidisciplinary breast centre (MBC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped wedge randomized controlled trial (cross-over type)

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 21, 2022
• Study Start: June 1, 2024
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: August 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)