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Active, Not Recruiting

NCT Number: NCT06503185

The PREPARE for Cancer Surgery Study

Our team recently closed recruitment for the PREPARE Trial: PReoperative Exercise to decrease PostoperAtive complication Rates and disability scorEs. The trial enrolled a total of 850 participants; 523 of which were recruited locally at The Ottawa Hospital (TOH). Of the 523 enrolled at TOH, 413 patient participants were on the pathway for cancer surgery and have either completed the study or are in follow-up (participants who withdrew from the full study have been excluded from the sample size in this sub-study proposal). Unexpectedly, almost 80% of the PREPARE Trial sample was linked to cancer surgery - most likely because cancer surgeries were prioritized during the pandemic. This provides us with the opportunity, and perhaps the responsibility, to specifically assess oncology related outcomes. We propose to follow this TOH sub-group of oncology patients for five years following their surgical date, by retrospectively collecting clinical and health administrative data at annual timepoints.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Surgery-Complications Cancer Disability Physical Frailty Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital

Ottawa, Ontario, Canada

About this study

Background: Among cancer surgery patients, systematic reviews suggest a 55% relative improvement in cancer free survival after multimodal prehabilitation. Unfortunately, prehabilitation trials have largely excluded individuals living with frailty. Simply put, we urgently require data from multicenter prehabilitation trials testing interventions that: A) support adequate adherence; and B) focus on older people with frailty having cancer surgery.

Research aims:

  • Does participation in home-based, multimodal prehabilitation improve 5-year event free survival among older adults with frailty having cancer surgery?
  • Does participation in home-based, multimodal prehabilitation improve physical recovery as assessed using patient reported disability scores across the first year after surgery among older adults with frailty having cancer surgery?
  • Does participation in home-based, multimodal prehabilitation lead to earlier return to intended oncologic treatment among older adults with frailty having cancer surgery?

Methods:

Design, setting and participants: This is a cancer-specific sub-study of the PREPARE Trial. This will be a retrospective cohort study performed using clinical and health administrative data from the electronic medical record (EPIC). People => 60 years old with frailty (Clinical Frailty Scale score of 4/9) and cancer having major elective non-cardiac surgery (vascular, intrathoracic, intraabdominal, pelvic, ENT) with expected length of stay of => 2 days will be included.

Intervention: Home-based exercise program with demonstrated efficacy, feasibility and acceptability tailored for people with frailty.

Outcomes and sample size: The primary outcome is event free survival (EFS) in the 5 years after surgery. Secondary outcomes include patient-reported disability trajectory in the year after surgery (WHODAS) and return to intended oncologic treatment (RIOT). Tertiary outcomes include measures of function, complications, survival, and resource use.

Based on our sample size and expected event rate, with 413 patients we will have >80% power to detect a HR=0.7 assuming a median time to event of 2.5 years in the control group).

Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.

Expected Outcomes: This study will allow us to understand whether prehabilitation is an intervention that can improve both oncologic and physical outcomes through improved recovery for this growing demographic of vulnerable older adults.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥60 years
  • Scheduled, or on the pathway, for elective surgery eLOS ≥2 days
  • Expected surgery date between 3 and 12 weeks from enrollment
  • Clinical Frailty Scale (CFS) score ≥4/9

Exclusion criteria

  • Inability to speak English or French
  • Co-morbidity preventing assessment or understanding of questionnaires
  • Unable to be contacted by telephone
  • Unwilling to participate in exercise program
  • Cardiac, neurological or orthopedic procedure
  • Palliative surgery
  • Certain cardiovascular conditions

Treatment and study plan

Prehabilitation

Behavioral

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.

Primary outcomes

  1. Event free survival (EFS) in the 5 years after surgery

    Time frame: 5 years

    Event free survival (similar to disease free survival, but more appropriate for scenarios where surgery is planned after randomization, but could be precluded by disease progression) will be defined using US Food and Drug Administration (FDA) criteria as: the time after randomization to the earliest of a) progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.

Secondary outcomes

  1. Patient-reported disability trajectory in the year after surgery measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

    Time frame: 1 year after surgery

    WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Scores will be normalized to a 100-point scale where higher scores indicate higher disability, with a difference of 5-points representing a minimally important difference after surgery.

  2. Return to intended oncologic treatment (RIOT)

    Time frame: at 4 months after surgery

    This outcome is measured as the time from surgery to initiation (or re-initiation) or chemo-, radiation- or immuno-therapy after surgery, and will be retrospectively censored at 4-months after surgery to reflect variable recommended timeframes for initiation of adjuvant therapy across cancer types

Other outcomes

  1. Function- Katz Index of Activities of Daily Living

    Time frame: Day 3, 5, 7 and up to 30 days after surgery

    The Katz Index measures function in activities of daily living (ADL). The ADLs examined are bathing, dressing, toileting, transferring, continence and feeding. If a person is able to perform the ADL independently, they receive 1 point for that activity. If a person is dependent on others to perform the ADL, they receive 0 points for that activity. A score of 6 is high, meaning the person is independent whereas a score of 0 is low, indicating that the person is very dependent.

  2. Function- Falls

    Time frame: Day 3, 5, 7 and up to 30 days after surgery

    Falls will be documented as a way of assessing function.

  3. Function- Health-related quality of life

    Time frame: Day 3, 5, 7 and up to 30 days after surgery

    EQ5D5L will be used to measure health-related quality of life at baseline and in-hospital after surgery. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine).

  4. Complications

    Time frame: Day 3, 5, 7 and up to 30 days after surgery

    Complications will be collected using the Post-Operative Morbidity Survey, a well-validated prospective instrument for identifying in-hospital complications in key organ systems based on objective criteria

  5. Health system- Discharge disposition

    Time frame: 1 year

    Discharge disposition will be prospectively collected. Assess where the participant will be discharged to once out of hospital.

  6. Health system- Readmissions

    Time frame: 1 year

    Readmissions will be prospectively collected. Linkage to administrative data will allow for collection of readmissions in the year after surgery.

  7. Health system- Long-term care admissions

    Time frame: 1 year

    Linkage to administrative data will allow for collection of subsequent long-term care admissions in the year after surgery.

  8. Health system- Emergency department visits

    Time frame: 1 year

    Emergency department visits since hospital discharge will be captured in the year after surgery

  9. Health system- Healthcare system costs

    Time frame: 1 year

    Linkage to administrative data will allow for collection of health system costs in the year after surgery.

  10. Overall survival

    Time frame: 5 years

    Survival will be confirmed through linkage to health administrative data

  11. Participant feedback

    Time frame: Participants are asked to reflect on the program during a call the day before surgery

    A theoretical domains framework participant survey will identify barriers and facilitators to participation in the exercise group. Responses are on a five-point likert scale ranging from "strongly disagree" to "strongly agree", or "never" to "always" depending on the question asked

  12. Safety (Adverse Events)

    Time frame: Pre-surgery

    Falls, cardiac or respiratory events and unplanned healthcare encounters will be collected during the exercise treatment period. Expert adjudication will determine whether they were study-attributable

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Multimodal PReoperative Exercise to Decrease PostoperAtive Disability, Cancer RecurrencE and Mortality in Older People With Frailty

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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