NCT03154671

Brief Summary

A multicentre two-group parallel single-blind (outcome assessor) randomized controlled trial (RCT). A cost effectiveness study alongside a clinical trial using a payer and societal perspective to study the cost-effectiveness of geriatric assessment and management compared to usual care will be conducted. Participants allocated to the control group will receive usual oncology care. Participants allocated to the intervention group will receive a comprehensive geriatric assessment and management in addition to their usual oncology care. The intervention will take 6 months to be completed. Total study follow-up will be 12 months for each participant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

May 10, 2017

Last Update Submit

May 19, 2022

Conditions

Cancer

Keywords

older adult;comprehensive geriatric assessmentchemotherapyintegrated carerandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

    Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

    6 months

  • Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

    Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale

    12 months

Secondary Outcomes (11)

  • Cost-effectiveness

    12 months

  • Functional status

    6 months

  • Functional status

    12 months

  • The number of geriatric issues successfully addressed for participants in intervention group

    6 months

  • Treatment toxicity

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

At study enrollment participants allocated to the intervention arm will complete a comprehensive geriatric assessment with the study intervention team (nurse and physician). Based on these findings a care plan tailored to the needs of the older adult with cancer will be developed and implemented. The study intervention nurse will call the participant at least monthly to follow up and evaluate the care (e.g. whether adjustments are required) and more if needed. All participants will receive a monthly healthy aging newsletter.

Other: Geriatric assessment and management

Control group

NO INTERVENTION

The participant will receive usual care from their treating oncology team. All participants will receive a monthly healthy aging newsletter.

Interventions

Geriatric assessment and managementOTHER

Each participant will receive a comprehensive geriatric assessment at baseline. Based on the issues identified, a tailored care plan will be developed with the participant to address the issues identified.

Intervention group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged 70+ with any solid tumor (excluding pancreatic) or lymphoma/myeloma referred for first/second line adjuvant/curative or palliative chemotherapy (cannot have received more than 1 cycle),
  • Able to speak English/French,
  • Have a physician-estimated life expectancy \>6 months,
  • Have an ECOG Performance Score 0-2 (indicating participants are ambulatory and able to complete all self-care activities),
  • Able to give informed consent.

You may not qualify if:

  • Receiving palliative care services upon recruitment
  • Already participating in another psychosocial/educational intervention study (new treatment study is allowed if the participants would like to participate in 2 studies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5T 2M9, Canada

Location

Related Publications (3)

  • Habib MH, Alibhai SMH, Puts M. How representative are participants in geriatric oncology clinical trials? The case of the 5C RCT in geriatric oncology: A cross-sectional comparison to a geriatric oncology clinic. J Geriatr Oncol. 2024 Mar;15(2):101703. doi: 10.1016/j.jgo.2024.101703. Epub 2024 Jan 15.

    PMID: 38228054DERIVED

  • Puts M, Alqurini N, Strohschein F, Koneru R, Szumacher E, Mariano C, Monette J, Hsu T, Brennenstuhl S, McLean B, Wills A, Berger A, Amir E, Romanovsky L, Li A, Mehta R, Krzyzanowska M, Elser C, Jang R, Prica A, Wan-Chow-Wah D, Pitters E, Emmenegger U, Menjak IB, Bergman S, Lemonde M, Breunis H, Beland F, Alibhai SMH. Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial. J Clin Oncol. 2023 Feb 1;41(4):847-858. doi: 10.1200/JCO.22.01007. Epub 2022 Dec 6.

    PMID: 36473126DERIVED

  • Puts MTE, Hsu T, Mariano C, Monette J, Brennenstuhl S, Pitters E, Ray J, Wan-Chow-Wah D, Kozlowski N, Krzyzanowska M, Amir E, Elser C, Jang R, Prica A, Krahn M, Beland F, Bergman S, Koneru R, Lemonde M, Szumacher E, Zidulka J, Fung S, Li A, Emmenegger U, Mehta R, Flemming K, Breunis H, Alibhai SMH. Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial. BMJ Open. 2019 May 10;9(5):e024485. doi: 10.1136/bmjopen-2018-024485.

    PMID: 31079079DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Geriatric AssessmentTherapeutics

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Martine Puts, RN PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor and statistician will be blinded to group allocation
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 16, 2017

Study Start

April 10, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)