Program for frail or cognitively impaired patients undergoing cancer surgery
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 study is testing whether a special health program can help older patients who are frail or have memory issues recover better after cancer surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06022666 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single center, non-blinded randomized control trial at the Queen Elizabeth II hospital in Nova Scotia. It targets patients aged 75 and older who are scheduled for elective cancer surgery and have been screened for frailty and cognitive impairment. Participants will be randomized to receive either standard preoperative care or a specialized geriatric assessment through the PATH clinic, which aims to optimize health and care plans. The primary outcome will measure the time spent at home six months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 75 and older with a confirmed or highly suspicious diagnosis of certain cancers and mild to severe frailty.
Not a fit: Patients who are residents of long-term care facilities or those requiring urgent/emergent surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve postoperative outcomes and quality of life for frail and cognitively impaired elderly patients undergoing cancer surgery.
How similar studies have performed: Other studies have shown promising results in improving outcomes for frail elderly patients undergoing surgery, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Halifax, Nova Scotia
- QEII, Victoria General Hospital — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Richard Spence, MD, FRCSC — Queen Elizabeth II Health Sciences Center
- Study coordinator: Richard Spence, MD, FRCSC
- Email: Richard.Spence@dal.ca
- Phone: 1 647 612 5904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.