Assessing real-world quality of life and survival in cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• BC Cancer
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Cheryl Ho, MD
• Email: cho@bccancer.bc.ca
• Phone: 604 877 6000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.