Assessing real-world quality of life and survival in cancer treatment
Evidence Development in Cancer Treatment - Real World: PREDiCTrw
This study is trying to see how well certain cancer treatments that haven't been fully proven yet can improve the quality of life and survival for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06242912 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the real-world quality of life and survival outcomes for cancer patients receiving therapies with preliminary evidence of efficacy but uncertain clinical benefit or cost-effectiveness. The study aims to collect real-world evidence through regular disease assessments and patient-reported outcomes using standardized quality of life questionnaires. By leveraging real-world data, the trial seeks to provide insights that can support clinical decision-making and reduce uncertainty regarding treatment effectiveness. The focus is on therapies that lack robust randomized clinical trial evidence, allowing patients to access potentially beneficial treatments while contributing to evidence generation.
Who should consider this trial
Good fit: Ideal candidates include cancer patients with ongoing questions about the effectiveness and cost-effectiveness of their therapeutic agents, who have a life expectancy of at least 12 weeks.
Not a fit: Patients with advanced cancer who are not expected to survive for at least 12 weeks or those with ECOG performance status greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and quality of life impacts of cancer therapies, aiding in better treatment decisions for patients.
How similar studies have performed: Other studies utilizing real-world data to assess treatment effectiveness in cancer have shown promise, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with cancer for which there remains ongoing questions regarding clinical effectiveness and/or cost effectiveness regarding a therapeutic agent * Eastern Co-operative Group (ECOG) 0-2 * Life expectancy of at least 12 weeks * Adequate hematologic and end organ function for drug treatment per the clinician's assessment * Asymptomatic or treated brain metastases permitted * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than 1% per year during the treatment period and for at least 5 months after the last dose. * For men: agreement to remain abstinent (refrain from heterosexual intercourse with a female partner of childbearing potential or who is pregnant) or use contraceptive measures, and agreement to refrain from donating sperm, during the treatment period and for at least 5 months after the last dose. * Ability to give informed consent for the study procedures defined in this protocol. Exclusion Criteria: * Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to enrollment. * Inability to complete quality of life questionnaires * Pregnancy or breastfeeding. * Any significant cardiovascular disease, comorbidity (i.e. recent major infection, HIV, tuberculosis) or major surgical procedure within 21 days that in the opinion of the investigator renders the proposed treatment unsafe. * Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
Where this trial is running
Vancouver, British Columbia
- BC Cancer — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Cheryl Ho, MD
- Email: cho@bccancer.bc.ca
- Phone: 604 877 6000
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.