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CancerNCT03154671

Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer

A study testing Geriatric assessment and management in people with Cancer, run by University of Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Cancer
What is being tested?
Geriatric assessment and management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
2 sitesCanada
Study dates
10 Apr 2018to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5T 2M9

Other trials in Canada

About this study

Official title: Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study

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.

Conditions
Cancer
Being tested
Geriatric assessment and management
Keywords
older adult;, comprehensive geriatric assessment, chemotherapy, integrated care, randomized controlled trial
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03154671
Study groupRoleWhat they receive
Intervention groupExperimentalAt 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.
Receives: Other: Geriatric assessment and management
Control groupNo interventionThe participant will receive usual care from their treating oncology team. All participants will receive a monthly healthy aging newsletter.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 months

  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

    Measured: 12 months

Secondary outcomes (11)

  1. Cost-effectiveness

    Cost-effectiveness will be determined alongside the clinical trial following standard guidelines. 2 methods to collect data needed for the cost-effectiveness analyses: 1) EQ-5D-5L and 2) patient health care use diaries

    Measured: 12 months

  2. Functional status

    Instrumental Activities of Daily Living (OARS IADL questionnaire)

    Measured: 6 months

  3. Functional status

    Instrumental Activities of Daily Living (OARS IADL questionnaire)

    Measured: 12 months

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

    The number of referrals/recommendations made to the participant and the number implemented by the participant

    Measured: 6 months

  5. Treatment toxicity

    Grade 3-5 chemotherapy treatment toxicity using the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)[12] and treatment completion rate (number of cycles received) will be abstracted from the medical chart

    Measured: 6 months

  6. Unplanned health care use

    Unplanned hospitalization and emergency department visits abstracted from patient diary and medical chart

    Measured: 6 months

  7. Satisfaction with care provided

    Older adult and medical oncologists will be asked to rate their satisfaction with the intervention

    Measured: 6 months

  8. Satisfaction with intervention

    Older adult and medical oncologists will be asked to rate their satisfaction with the intervention

    Measured: 12 months

  9. Cancer treatment plan modification

    Whether the medical oncologist changed the treatment plan after receiving the geriatric assessment results

    Measured: 3 months

  10. Overall survival

    Overall survival will be abstracted from the medical chart

    Measured: 12 months

  11. Intervention fidelity by treatment centre

    A detailed process evaluation looking at the implementation of the intervention by centre will be conducted

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start10 Apr 2018
  3. Primary completion1 Apr 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03154671
Sponsor's protocol ID
705046
Status last verified
May 2022
First submitted
10 May 2017
Last updated
20 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38228054

  • 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.

    PubMed 36473126

  • 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.

    PubMed 31079079

Questions about this trial

What is this clinical trial studying?

A study testing Geriatric assessment and management in people with Cancer, run by University of Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03154671, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.

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