Clinical trial · Observational
The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goals of this observational study is to 1. To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology 2. To develop guidelines/recommendations for the use of PROMs in ACT trials Participants will be recruited in four separate stages: Stage 1: Semi-structured interviews to generate PROM items. Stage 2: Cognitive interviews to ensure that all items are clear and easily understood. Stage 3: Initial pilot of the draft PROM to enable item reduction and refinement. Stage 4: Pilot of final PROM to assess acceptability in a clinical setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Pre-Infusion
- description
- Participants prior to commencing Adoptive Cell Therapy (ACT).
- label
- Acute
- description
- Participants either receiving ACT or up to 30 days post treatment.
- label
- Sub-acute
- description
- Up to 12 months post ACT.
- label
- Long term follow up
- description
- From 12 months post ACT onwards
Primary outcomes (2)
- measure
- Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available