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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02222259
Date of registration: 18/08/2014
Prospective Registration: Yes
Primary sponsor: University of Toronto
Public title: A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients
Scientific title: A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)
Date of first enrolment: September 2014
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02222259
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Martine Puts, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Toronto
Name:     Shabbir Alibhai, MD
Address: 
Telephone:
Email:
Affiliation:  University Health Network, Toronto
Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of advanced (stage 2, 3 or 4) Gastrointestinal, Genitourinary, or
breast cancer

- Referred for first-line chemotherapy

- Ability to speak English

- Physician estimated life expectancy >6 months

- An Eastern Oncology Group Collaborative (ECOG) Performance Score of 0-2

- Ability to provide informed consent

Exclusion Criteria:

- Previous chemotherapy for current stage of disease



Age minimum: 70 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Gastrointestinal Cancer
Breast Cancer
Genitourinary Cancer
Intervention(s)
Procedure: GA and Integrated Care Plan
Primary Outcome(s)
Quality of life [Time Frame: 6 months]
Secondary Outcome(s)
Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire [Time Frame: 6 months]
Functional status [Time Frame: 6 months]
Secondary ID(s)
14-7879-CE
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University Health Network, Toronto
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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