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

NCT02222259 | Completed

• 1 other identifier: 14-7879-CE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Gastrointestinal Cancer; Genitourinary Cancer

Keywords

Geriatric Oncology; Quality of Life; Comprehensive Geriatric Assessment; Functional Status; Chemotherapy; Older Adults

Outcome Measures

Primary Outcomes (1)

• Quality of life

  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)

  6 months

Secondary Outcomes (2)

• Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire

  6 months

• Functional status

  6 months

Study Arms (2)

GA and Integrated Care Plan

EXPERIMENTAL

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

Standard oncology care

NO INTERVENTION

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

Interventions

GA and Integrated Care Plan 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?

GA and Integrated Care Plan

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous chemotherapy for current stage of disease

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5T 2M9, Canada

Location

Related Publications (2)

• 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.

  PMID: 30041978 DERIVED

• 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.

  PMID: 28741175 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms; Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shabbir Alibhai, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Martine Puts, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 21, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CA (1)