PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery.

NCT06022666 | Recruiting

• 1 other identifier: PATHTrial
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Frailty; Oncology Problem; Cognitive Impairment

Keywords

frailty; cognitive impairment; cancer surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  At 6 months postoperatively

• Preoperative factors associated with decreased proportion of time spent at home at 6 months.

  At 6 months postoperatively

Secondary Outcomes (5)

• Number of participants requiring home care utilization

  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.

  Assessed from date of index surgery to 6 months postoperatively.

• Preoperative factors associated with increased home care utilization, death, or new onset disability.

  Assessed up to 6 months postoperatively.

• Rate of change to a non-operative strategy

  Assessed from date of randomization until documented confirmation that patient has opted for non surgical approach, assessed up to 6 months.

• Decision regret scores.

  Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.

Study Arms (2)

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

Other: Geriatric assessment

Interventions

Geriatric assessment OTHER

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.

PATH geriatric care

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• a. Mild or greater frailty (CFS equal or greater than 5) due to cognitive impairment.
• b. Moderate or greater frailty (CFS equal or greater than 6) due to medical/physical conditions.
• \. Informed consent for participation must be received.

You may not qualify if:

• Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis.
• Urgent/ emergent cases are excluded.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII, Victoria General Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Related Publications (11)

• 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.

  PMID: 33978695 BACKGROUND

• Finlayson EV, Birkmeyer JD. Operative mortality with elective surgery in older adults. Eff Clin Pract. 2001 Jul-Aug;4(4):172-7.

  PMID: 11525104 BACKGROUND

• McIsaac 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.

  PMID: 30048320 BACKGROUND

• Zhang 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.

  PMID: 33549566 BACKGROUND

• Spence 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.

  PMID: 33151504 BACKGROUND

• Spence 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.

  PMID: 33098049 BACKGROUND

• Theou 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.

  PMID: 33605412 BACKGROUND

• Hall 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.

  PMID: 27902826 BACKGROUND

• Chesney 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.

  PMID: 32980211 BACKGROUND

• Moorhouse 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.

  PMID: 23110462 BACKGROUND

• Chesney 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.

  PMID: 33026417 BACKGROUND

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Richard Spence, MD, FRCSC

  Queen Elizabeth II Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Spence, MD, FRCSC

CONTACT

1 647 612 5904; Richard.Spence@dal.ca

Damsadie Hannedige, BSc, MSc

CONTACT

902-225-8972; damsadie.hannedige@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: September 5, 2023
• Study Start: January 31, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)