FrailtyNCT06022666
PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery.
A study testing Geriatric assessment in people with Frailty and Oncology Problem, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
This is a single center, non-blinded randomized control trial taking place at the Queen Elizabeth II hospital (QEII) in Nova Scotia. Patients are eligible if aged 75 and older scheduled for elective cancer surgery (proven cancer or highly suspicious cancer) and screened to have mild or greater frailty (with cognitive… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Oncology Problem, Cognitive Impairment
- What is being tested?
- Geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2024to Mar 2026
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have a clinically highly suspicious or pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal (including head and neck surgery), orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancer surgery.
- Patients must be scheduled and consented for curative or palliative intent surgery.
- Patients must be aged 75 or older.
- Patients must be screened by the CFS to have:
- 4a. Mild or greater frailty (CFS equal or greater than 5) due to cognitive impairment.
- 4b. Moderate or greater frailty (CFS equal or greater than 6) due to medical/physical conditions.
- 5. Informed consent for participation must be received.
Who cannot join
- Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis.
- Urgent/ emergent cases are excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
QEII, Victoria General Hospital
Halifax, Nova Scotia, B3H 2Y9
Richard Spence, 647-612-5904
Damsadie Hannedige, 902-225-8972
About this study
Official title: Application of the Palliative and Therapeutic Harmonization (PATH) Program for Shared-decision Making for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery: a Randomized Control Trial.
This is a single center, non-blinded randomized control trial taking place at the Queen Elizabeth II hospital (QEII) in Nova Scotia. Patients are eligible if aged 75 and older scheduled for elective cancer surgery (proven cancer or highly suspicious cancer) and screened to have mild or greater frailty (with cognitive impairments) or moderate to greater frailty (with medical/physical conditions). Eligible participants will then be randomized to preoperative standard of care or geriatric assessment through the PATH clinic. Primary outcome will assess time spend at home at 6 months after the surgery.
Read the detailed description
At Nova Scotia Health Authority (NSHA), geriatric medicine colleagues developed a preoperative palliative and therapeutic harmonization (PATH) clinic with the following objectives:
- Assess medical conditions, health trajectory, and baseline frailty.
- Conduct an in-depth discussion with the patient (or their substitute decision maker) to review medical conditions and how frailty stage impacts decision-making about surgery.
- Co-develop a care plan, including ways to optimize health.
The investigators have elaborated a single center randomized cohort trial for patients aged 75 and older, screened as severely frail or cognitively impaired scheduled for curative or palliative-intent surgery for bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancers (proven or clinically highly suspicious cancer).
Patients enrolled in the trial will be randomized to standard of care preoperative assessment versus PATH geriatric care arm.
- Conditions
- Frailty, Oncology Problem, Cognitive Impairment
- Being tested
- Geriatric assessment
- Keywords
- frailty, cognitive impairment, cancer surgery
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessmentOther
Geriatric assessment through PATH clinic which includes an evaluation of comorbidities, health trajectory and baseline frailty as well as conducting an in-depth discussion with the patient on how frailty stage impacts decision-making about surgery in order to co-develop a care plan.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment. |
| PATH geriatric care | Experimental | Pre-operative assessment through the PATH clinic Receives: Other: Geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent at home 6 months following cancer surgery.
Number of days spent at home vs in a hospital or care-facility unit dichotomized as low vs high time at home. High time at home defined as 14 or fewer institution days, and low time defined as more than 14 institution days at 6 months.
Measured: At 6 months postoperatively
Preoperative factors associated with decreased proportion of time spent at home at 6 months.
Measured: At 6 months postoperatively
Secondary outcomes (5)
Number of participants requiring home care utilization
Receipt of any homeware service (nursing, wound care, social workers, physiotherapy) from the day of postoperative discharge from the hospital.
Measured: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
Number of participants experiencing death or development of persistent significant new disability.
Participant passing away or developing a new disability, from the day of index surgery. Assessed using the WHODAS 2.0 disability scale.
Measured: Assessed from date of index surgery to 6 months postoperatively.
Preoperative factors associated with increased home care utilization, death, or new onset disability.
Measured: Assessed up to 6 months postoperatively.
Rate of change to a non-operative strategy
Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation.
Measured: Assessed from date of randomization until documented confirmation that patient has opted for non surgical approach, assessed up to 6 months.
Decision regret scores.
Decisional Regret Scale ranging from 0-100 scores measure the distress or remorse regarding the patient's decision made about undergoing surgery.
Measured: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start31 Jan 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Spence, MD, FRCSC, Principal investigator, Queen Elizabeth II Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022666
- Sponsor's protocol ID
- PATHTrial
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chesney TR, Coburn N, Mahar AL, Davis LE, Zuk V, Zhao H, Hsu AT, Wright F, Haas B, Hallet J; Recovery After Surgical Therapy for Older Adults Research-Cancer (RESTORE-Cancer) Group. All-Cause and Cancer-Specific Death of Older Adults Following Surgery for Cancer. JAMA Surg. 2021 Jul 1;156(7):e211425. doi: 10.1001/jamasurg.2021.1425. Epub 2021 Jul 14.
PubMed 33978695Finlayson EV, Birkmeyer JD. Operative mortality with elective surgery in older adults. Eff Clin Pract. 2001 Jul-Aug;4(4):172-7.
PubMed 11525104McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
PubMed 30048320Zhang XM, Jiao J, Xie XH, Wu XJ. The Association Between Frailty and Delirium Among Hospitalized Patients: An Updated Meta-Analysis. J Am Med Dir Assoc. 2021 Mar;22(3):527-534. doi: 10.1016/j.jamda.2021.01.065. Epub 2021 Feb 5.
PubMed 33549566Spence RT, Hirpara DH, Doshi S, Quereshy FA, Chadi SA. ASO Author Reflections: A Reductionist's Approach to Risk-Adjusted Predictions and Outcomes Assessment: Less is More. Ann Surg Oncol. 2021 May;28(5):2788-2789. doi: 10.1245/s10434-020-09284-x. Epub 2020 Nov 5. No abstract available.
PubMed 33151504Spence RT, Hirpara DH, Doshi S, Quereshy FA, Chadi SA. Will My Patient Survive an Anastomotic Leak? Predicting Failure to Rescue Using the Modified Frailty Index. Ann Surg Oncol. 2021 May;28(5):2779-2787. doi: 10.1245/s10434-020-09221-y. Epub 2020 Oct 23.
PubMed 33098049Theou O, Perez-Zepeda MU, van der Valk AM, Searle SD, Howlett SE, Rockwood K. A classification tree to assist with routine scoring of the Clinical Frailty Scale. Age Ageing. 2021 Jun 28;50(4):1406-1411. doi: 10.1093/ageing/afab006.
PubMed 33605412Hall DE, Arya S, Schmid KK, Carlson MA, Lavedan P, Bailey TL, Purviance G, Bockman T, Lynch TG, Johanning JM. Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days. JAMA Surg. 2017 Mar 1;152(3):233-240. doi: 10.1001/jamasurg.2016.4219.
PubMed 27902826Chesney TR, Haas B, Coburn N, Mahar AL, Davis LE, Zuk V, Zhao H, Wright F, Hsu AT, Hallet J. Association of frailty with long-term homecare utilization in older adults following cancer surgery: Retrospective population-based cohort study. Eur J Surg Oncol. 2021 Apr;47(4):888-895. doi: 10.1016/j.ejso.2020.09.009. Epub 2020 Sep 16.
PubMed 32980211Moorhouse P, Mallery LH. Palliative and therapeutic harmonization: a model for appropriate decision-making in frail older adults. J Am Geriatr Soc. 2012 Dec;60(12):2326-32. doi: 10.1111/j.1532-5415.2012.04210.x. Epub 2012 Oct 30.
PubMed 23110462Chesney TR, Haas B, Coburn NG, Mahar AL, Zuk V, Zhao H, Wright FC, Hsu AT, Hallet J; Recovery After Surgical Therapy for Older Adults Research-Cancer (RESTORE-Cancer) Group. Patient-Centered Time-at-Home Outcomes in Older Adults After Surgical Cancer Treatment. JAMA Surg. 2020 Nov 1;155(11):e203754. doi: 10.1001/jamasurg.2020.3754. Epub 2020 Nov 18.
PubMed 33026417
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Palliative and Therapeutic Harmonization (PATH) Program for Shared-decision Making for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06022666
- Acronym / sponsor ID
- PATHTrial
- Conditions
- Frailty, Oncology Problem, Cognitive Impairment
- Keywords
- frailty, cognitive impairment, cancer surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, non-blinded randomized control trial taking place at the Queen Elizabeth II hospital (QEII) in Nova Scotia. Patients are eligible if aged 75 and older scheduled for elective cancer surgery (proven cancer or highly suspicious cancer) and screened to have mild or greater frailty (with cognitive impairments) or moderate to greater frailty (with medical/physical conditions). Eligible participants will then be randomized to preoperative standard of care or geriatric assessment through the PATH clinic. Primary outcome will assess time spend at home at 6 months after the surgery.
Detailed description
At Nova Scotia Health Authority (NSHA), geriatric medicine colleagues developed a preoperative palliative and therapeutic harmonization (PATH) clinic with the following objectives:
- Assess medical conditions, health trajectory, and baseline frailty.
- Conduct an in-depth discussion with the patient (or their substitute decision maker) to review medical conditions and how frailty stage impacts decision-making about surgery.
- Co-develop a care plan, including ways to optimize health.
The investigators have elaborated a single center randomized cohort trial for patients aged 75 and older, screened as severely frail or cognitively impaired scheduled for curative or palliative-intent surgery for bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancers (proven or clinically highly suspicious cancer).
Patients enrolled in the trial will be randomized to standard of care preoperative assessment versus PATH geriatric care arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment. |
| PATH geriatric care | Experimental | Other: Geriatric assessmentPre-operative assessment through the PATH clinic |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients must have a clinically highly suspicious or pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal (including head and neck surgery), orthopaedic, gynaecological, breast, genitourinary or gastrointestinal cancer surgery.
- Patients must be scheduled and consented for curative or palliative intent surgery.
- Patients must be aged 75 or older.
- Patients must be screened by the CFS to have:
- 4a. Mild or greater frailty (CFS equal or greater than 5) due to cognitive impairment.
Key exclusion criteria (2 listed)
- Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis.
- Urgent/ emergent cases are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric assessmentGeriatric assessment through PATH clinic which includes an evaluation of comorbidities, health trajectory and baseline frailty as well as conducting an in-depth discussion with the patient on how frailty stage impacts decision-making about surgery in order to co-develop a care plan. | Other | PATH geriatric care |
Primary outcome
Time spent at home 6 months following cancer surgery.
Time frame: At 6 months postoperatively
Number of days spent at home vs in a hospital or care-facility unit dichotomized as low vs high time at home. High time at home defined as 14 or fewer institution days, and low time defined as more than 14 institution days at 6 months.
Preoperative factors associated with decreased proportion of time spent at home at 6 months.
Time frame: At 6 months postoperatively
5 secondary outcomes
Number of participants requiring home care utilization
Time frame: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
Number of participants experiencing death or development of persistent significant new disability.
Time frame: Assessed from date of index surgery to 6 months postoperatively.
Preoperative factors associated with increased home care utilization, death, or new onset disability.
Time frame: Assessed up to 6 months postoperatively.
Rate of change to a non-operative strategy
Time frame: Assessed from date of randomization until documented confirmation that patient has opted for non surgical approach, assessed up to 6 months.
Decision regret scores.
Time frame: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 33978695Chesney TR, Coburn N, Mahar AL, Davis LE, Zuk V, Zhao H, Hsu AT, Wright F, Haas B, Hallet J; Recovery After Surgical Therapy for Older Adults Research-Cancer (RESTORE-Cancer) Group. All-Cause and Cancer-Specific Death of Older Adults Following Surgery for Cancer. JAMA Surg. 2021 Jul 1;156(7):e211425. doi: 10.1001/jamasurg.2021.1425. Epub 2021 Jul 14.
- Background: PubMed 11525104Finlayson EV, Birkmeyer JD. Operative mortality with elective surgery in older adults. Eff Clin Pract. 2001 Jul-Aug;4(4):172-7.
- Background: PubMed 30048320McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
- Background: PubMed 33549566Zhang XM, Jiao J, Xie XH, Wu XJ. The Association Between Frailty and Delirium Among Hospitalized Patients: An Updated Meta-Analysis. J Am Med Dir Assoc. 2021 Mar;22(3):527-534. doi: 10.1016/j.jamda.2021.01.065. Epub 2021 Feb 5.
- Background: PubMed 33151504Spence RT, Hirpara DH, Doshi S, Quereshy FA, Chadi SA. ASO Author Reflections: A Reductionist's Approach to Risk-Adjusted Predictions and Outcomes Assessment: Less is More. Ann Surg Oncol. 2021 May;28(5):2788-2789. doi: 10.1245/s10434-020-09284-x. Epub 2020 Nov 5. No abstract available.
- Background: PubMed 33098049Spence RT, Hirpara DH, Doshi S, Quereshy FA, Chadi SA. Will My Patient Survive an Anastomotic Leak? Predicting Failure to Rescue Using the Modified Frailty Index. Ann Surg Oncol. 2021 May;28(5):2779-2787. doi: 10.1245/s10434-020-09221-y. Epub 2020 Oct 23.
- Background: PubMed 33605412Theou O, Perez-Zepeda MU, van der Valk AM, Searle SD, Howlett SE, Rockwood K. A classification tree to assist with routine scoring of the Clinical Frailty Scale. Age Ageing. 2021 Jun 28;50(4):1406-1411. doi: 10.1093/ageing/afab006.
- Background: PubMed 27902826Hall DE, Arya S, Schmid KK, Carlson MA, Lavedan P, Bailey TL, Purviance G, Bockman T, Lynch TG, Johanning JM. Association of a Frailty Screening Initiative With Postoperative Survival at 30, 180, and 365 Days. JAMA Surg. 2017 Mar 1;152(3):233-240. doi: 10.1001/jamasurg.2016.4219.
- Background: PubMed 32980211Chesney TR, Haas B, Coburn N, Mahar AL, Davis LE, Zuk V, Zhao H, Wright F, Hsu AT, Hallet J. Association of frailty with long-term homecare utilization in older adults following cancer surgery: Retrospective population-based cohort study. Eur J Surg Oncol. 2021 Apr;47(4):888-895. doi: 10.1016/j.ejso.2020.09.009. Epub 2020 Sep 16.
- Background: PubMed 23110462Moorhouse P, Mallery LH. Palliative and therapeutic harmonization: a model for appropriate decision-making in frail older adults. J Am Geriatr Soc. 2012 Dec;60(12):2326-32. doi: 10.1111/j.1532-5415.2012.04210.x. Epub 2012 Oct 30.
- Background: PubMed 33026417Chesney TR, Haas B, Coburn NG, Mahar AL, Zuk V, Zhao H, Wright FC, Hsu AT, Hallet J; Recovery After Surgical Therapy for Older Adults Research-Cancer (RESTORE-Cancer) Group. Patient-Centered Time-at-Home Outcomes in Older Adults After Surgical Cancer Treatment. JAMA Surg. 2020 Nov 1;155(11):e203754. doi: 10.1001/jamasurg.2020.3754. Epub 2020 Nov 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Spence, MD, FRCSC principal investigator
Queen Elizabeth II Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric assessment in people with Frailty and Oncology Problem, run by Nova Scotia Health Authority at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Spence, MD, FRCSC (1 647 612 5904, Richard.Spence@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent at home 6 months following cancer surgery. (time frame: At 6 months postoperatively). 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 NCT06022666, which also lists 11 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 23 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.