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

Primary Purpose

Frailty, Oncology Problem, Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Geriatric assessment
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty focused on measuring frailty, cognitive impairment, cancer surgery

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast 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. Exclusion Criteria: Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis. Urgent/ emergent cases are excluded.

Sites / Locations

  • QEII, Victoria General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

PATH geriatric care

Arm Description

Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment.

Pre-operative assessment through the PATH clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Preoperative factors associated with increased home care utilization, death, or new onset disability.
Rate of change to a non-operative strategy
Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation.
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.

Full Information

First Posted
April 13, 2023
Last Updated
August 31, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT06022666
Brief Title
PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Oncology Problem, Cognitive Impairment
Keywords
frailty, cognitive impairment, cancer surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment.
Arm Title
PATH geriatric care
Arm Type
Experimental
Arm Description
Pre-operative assessment through the PATH clinic
Intervention Type
Other
Intervention Name(s)
Geriatric assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time spent at home 6 months following cancer surgery.
Description
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.
Time Frame
At 6 months postoperatively
Title
Preoperative factors associated with decreased proportion of time spent at home at 6 months.
Time Frame
At 6 months postoperatively
Secondary Outcome Measure Information:
Title
Number of participants requiring home care utilization
Description
Receipt of any homeware service (nursing, wound care, social workers, physiotherapy) from the day of postoperative discharge from the hospital.
Time Frame
Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.
Title
Number of participants experiencing death or development of persistent significant new disability.
Description
Participant passing away or developing a new disability, from the day of index surgery. Assessed using the WHODAS 2.0 disability scale.
Time Frame
Assessed from date of index surgery to 6 months postoperatively.
Title
Preoperative factors associated with increased home care utilization, death, or new onset disability.
Time Frame
Assessed up to 6 months postoperatively.
Title
Rate of change to a non-operative strategy
Description
Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation.
Time Frame
Assessed from date of randomization until documented confirmation that patient has opted for non surgical approach, assessed up to 6 months.
Title
Decision regret scores.
Description
Decisional Regret Scale ranging from 0-100 scores measure the distress or remorse regarding the patient's decision made about undergoing surgery.
Time Frame
Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a pathologically confirmed diagnosis of bronchopulmonary, oropharyngeal, orthopaedic, gynaecological, breast 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. Exclusion Criteria: Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis. Urgent/ emergent cases are excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Spence, MD, FRCSC
Phone
1 647 612 5904
Email
Richard.Spence@dal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Tremblay, MD, FRCSC
Phone
514-826-4146
Email
elizabeth.tremblay@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Spence, MD, FRCSC
Organizational Affiliation
Queen Elizabeth II Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII, Victoria General Hospital
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Spence
Phone
647-612-5904

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33978695
Citation
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.
Results Reference
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11525104
Citation
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Results Reference
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PubMed Identifier
30048320
Citation
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.
Results Reference
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PubMed Identifier
33549566
Citation
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Results Reference
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PubMed Identifier
33151504
Citation
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.
Results Reference
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PubMed Identifier
33098049
Citation
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.
Results Reference
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PubMed Identifier
33605412
Citation
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.
Results Reference
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PubMed Identifier
27902826
Citation
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.
Results Reference
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PubMed Identifier
32980211
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery.

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