Clinical trial NCT02222259: A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients
Official title: A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Keywords: Geriatric Oncology
Quality of Life
Comprehensive Geriatric Assessment
Functional Status
Chemotherapy
Older Adults
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2014-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.

Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.

Detailed description: Introduction: A comprehensive geriatric assessment (CGA) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. However, few randomized controlled trials (RCTs) have been completed showing the evidence.

OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer METHODS -

A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. The co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.

Recruitment has been completed November 2015

Eligibility 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

Primary outcomes:
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire
timeFrame: 6 months
measure: Functional status
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Shabbir Alibhai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Martine Puts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sattar S, Alibhai SMH, Brennenstuhl S, Kulik M, MacDonald ME, McWatters K, Lee K, Jang R, Amir E, Krzyzanowska MK, Joshua AM, Monette J, Wan-Chow-Wah D, Puts MTE. Health status, emergency department visits, and oncologists' feedback: An analysis of secondary endpoints from a randomized phase II geriatric assessment trial. J Geriatr Oncol. 2019 Jan;10(1):169-174. doi: 10.1016/j.jgo.2018.06.014. Epub 2018 Jul 21.
citation: Puts MTE, Sattar S, Kulik M, MacDonald ME, McWatters K, Lee K, Brennenstuhl S, Jang R, Amir E, Krzyzanowska MK, Joshua AM, Monette J, Wan-Chow-Wah D, Alibhai SMH. A randomized phase II trial of geriatric assessment and management for older cancer patients. Support Care Cancer. 2018 Jan;26(1):109-117. doi: 10.1007/s00520-017-3820-7. Epub 2017 Jul 25.