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A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Martine Puts, University of Toronto
ClinicalTrials.gov Identifier:
NCT02222259
First received: August 18, 2014
Last updated: October 28, 2016
Last verified: October 2016
  Purpose

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 Intervention
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Procedure: GA and Integrated Care Plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)


Enrollment: 60
Study Start Date: September 2014
Estimated Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   70 Years and older   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02222259

Locations
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5T 2M9
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Investigators
Principal Investigator: Shabbir Alibhai, MD University Health Network, Toronto
Principal Investigator: Martine Puts, PhD University of Toronto
  More Information

Responsible Party: Martine Puts, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02222259     History of Changes
Other Study ID Numbers: 14-7879-CE 
Study First Received: August 18, 2014
Last Updated: October 28, 2016
Health Authority: Canada: Institutional Review Board

Keywords provided by University of Toronto:
Geriatric Oncology
Quality of Life
Comprehensive Geriatric Assessment
Functional Status
Chemotherapy
Older Adults

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Urogenital Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on December 02, 2016