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

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02222259

Collaborator

University Health Network, Toronto (Other)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Gastrointestinal Cancer Genitourinary Cancer	Procedure: GA and Integrated Care Plan	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

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 :

Sep 1, 2014

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Quality of life [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)

Secondary Outcome Measures

Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire [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 [6 months]
We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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