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

NCT ID: NCT02222259

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

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

Conditions

Breast Cancer; Gastrointestinal Cancer; Genitourinary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

GA and Integrated Care Plan

Intervention Type: PROCEDURE

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?

Standard oncology care

Participants randomized to standard oncology care will receive usual care from their oncology team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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?

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Martine Puts

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shabbir Alibhai, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Martine Puts, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30041978 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28741175 (View on PubMed)

Other Identifiers

14-7879-CE

Identifier Type: -

Identifier Source: org_study_id