Developing a quality of life measure for patients receiving cell therapy for cancer
The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
This study is trying to create a new tool to help cancer patients receiving cell therapy share their experiences and quality of life to improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 142 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | The Christie NHS Foundation Trust Academic / other |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05721365 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a Patient Reported Outcome Measure (PROM) specifically for patients undergoing Adoptive Cell Therapy (ACT) for cancer. The study will involve four stages: conducting semi-structured interviews with ACT patients to gather their experiences, performing cognitive interviews to refine the clarity of the PROM items, piloting the draft PROM for item reduction, and finally assessing the acceptability of the final PROM in a clinical setting. The goal is to enhance the understanding of quality of life and symptomatology in ACT patients and to establish guidelines for using PROMs in future ACT trials.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged over 16 who are currently enrolled in an Adoptive Cell Therapy clinical trial.
Not a fit: Patients under 16 or those unable to understand and communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a standardized tool to better assess and improve the quality of life for cancer patients undergoing cell therapy.
How similar studies have performed: While the development of PROMs is a common approach in clinical research, this specific application in the context of Adoptive Cell Therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are enrolled on Adoptive Cell Therapy (ACT) trial 2. Aged over 16 (no upper age limit) 3. Ability to understand and communicate in the English language 4. Able to provide written informed consent Exclusion Criteria: 1. Aged under 16 2. Unable to understand and communicate in the English language 3. Unable to provide written informed consent
Where this trial is running
Manchester
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Fiona Thistlethwaite, PhD — The Christie NHS Foundation Trust
- Study coordinator: Grant Punnett, MSc
- Email: grant.punnett@nhs.net
- Phone: +447427143635
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.