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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06022666
Recruitment Status : Not yet recruiting
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
Sponsor:
Information provided by (Responsible Party):
Richard Spence, Nova Scotia Health Authority

Study Description
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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 and screened as severely frail or cognitively impaired. 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.

Condition or disease Intervention/treatment Phase
Frailty Oncology Problem Cognitive Impairment Other: Geriatric assessment Not Applicable

Detailed Description:

At Nova Scotia Health Authority (NSHA), geriatric medicine colleagues developed a preoperative palliative and therapeutic harmonization (PATH) clinic with the following objectives:

  1. Assess medical conditions, health trajectory, and baseline frailty.
  2. 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. 3. 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 or gastrointestinal cancers.

Patients enrolled in the trial will be randomized to standard of care preoperative assessment versus PATH geriatric care arm.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of care
Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment.
Experimental: PATH geriatric care
Pre-operative assessment through the PATH clinic
 Other: Geriatric assessment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Preoperative factors associated with decreased proportion of time spent at home at 6 months. [ Time Frame: At 6 months postoperatively ]

Secondary Outcome Measures :
  1. Number of participants requiring home care utilization [ Time Frame: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively. ]
    Receipt of any homeware service (nursing, wound care, social workers, physiotherapy) from the day of postoperative discharge from the hospital.

  2. Number of participants experiencing death or development of persistent significant new disability. [ Time Frame: Assessed from date of index surgery to 6 months postoperatively. ]
    Participant passing away or developing a new disability, from the day of index surgery. Assessed using the WHODAS 2.0 disability scale.

  3. Preoperative factors associated with increased home care utilization, death, or new onset disability. [ Time Frame: Assessed up to 6 months postoperatively. ]
  4. 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. ]
    Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation.

  5. Decision regret scores. [ Time Frame: Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively. ]
    Decisional Regret Scale ranging from 0-100 scores measure the distress or remorse regarding the patient's decision made about undergoing surgery.


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast or gastrointestinal cancer surgery.
  2. Patients must be scheduled and consented for curative or palliative intent surgery.
  3. Patients must be aged 75 or older.
  4. 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.

Exclusion Criteria:

  1. Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis.
  2. Urgent/ emergent cases are excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022666


Contacts
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Contact: Richard Spence, MD, FRCSC 1 647 612 5904 Richard.Spence@dal.ca
Contact: Elizabeth Tremblay, MD, FRCSC 514-826-4146 elizabeth.tremblay@umontreal.ca

Locations
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Canada, Nova Scotia
QEII, Victoria General Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Richard Spence    647-612-5904      
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Richard Spence, MD, FRCSC Queen Elizabeth II Health Sciences Center
More Information
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Publications:

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Responsible Party: Richard Spence, Principal Investigator, Surgical Oncologist, Associate Beatrice Hunter Cancer Institute, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT06022666    
Other Study ID Numbers: PATHTrial
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Spence, Nova Scotia Health Authority:
frailty
cognitive impairment
cancer surgery
Additional relevant MeSH terms:
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Frailty
Cognitive Dysfunction
Cognition Disorders
 Neurocognitive Disorders
Mental Disorders
Pathologic Processes