A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02222259|
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Gastrointestinal Cancer Genitourinary Cancer||Procedure: GA and Integrated Care Plan||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: GA and Integrated Care Plan
Participants allocated to the intervention group will be seen in the geriatric oncology clinic where they will be assessed using a geriatric assessment. Based on the issues identified in the geriatric assessment, a care plan will be developed with the participant to address the issues.
Procedure: GA and Integrated Care Plan
The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment. The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?
No Intervention: Standard oncology care
Participants randomized to standard oncology care will receive usual care from their oncology team.
- Quality of life [ Time Frame: 6 months ]We will measure quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core version 30 items (EORTC QLQ C30)
- Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire [ Time Frame: 6 months ]
The treating oncologist will be asked to indicate the cancer treatment plan prior to receiving the geriatric assessment results using a survey previously used in the study of Dr. Alibhai et al (Am J Clin Oncol. 2012 Aug;35(4):322-8.).
After the GA the results will be send to the treating oncologist and after the physician will be asked to indicate whether or not and if yes how he/she modified the treatment plan based on the GA results
- Functional status [ Time Frame: 6 months ]We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222259
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5T 2M9|
|Principal Investigator:||Shabbir Alibhai, MD||University Health Network, Toronto|
|Principal Investigator:||Martine Puts, PhD||University of Toronto|