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

August 21, 2024 updated by: Nova Scotia Health Authority

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII, Victoria General Hospital
        • Contact:
          • Richard Spence
          • Phone Number: 647-612-5904
        • Contact:
          • Damsadie Hannedige
          • Phone Number: 902-225-8972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 6 months postoperatively
Preoperative factors associated with decreased proportion of time spent at home at 6 months.
Time Frame: At 6 months postoperatively
At 6 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
Participant passing away or developing a new disability, from the day of index surgery. Assessed using the WHODAS 2.0 disability scale.
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.
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.
Rate of patients randomized to PATH clinic arm that end up declining surgery after consultation.
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.
Decisional Regret Scale ranging from 0-100 scores measure the distress or remorse regarding the patient's decision made about undergoing surgery.
Assessed from date of hospital discharge (from index surgery) to 6 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Spence, MD, FRCSC, Queen Elizabeth II Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PATHTrial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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