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Trial Title:
The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
NCT ID:
NCT05721365
Condition:
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
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.
Detailed description:
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 patients who have taken part in ACT clinical trials.
Stage I - Item generation Approximately 20 participant interviews will be conducted with
ACT patients to capture their experiences of receiving ACTs including quality of life,
symptom experience, adverse events and other relevant themes that may emerge. The
investigators will aim to recruit a minimum of 3 participants in each of the following
groups: Pre-infusion; Acute (treatment- 30 days post treatment; Sub-acute- up to 12
months post treatment; Long-term follow-up- from 12 months post treatment onwards. The
interviews will be audio recorded and transcribed verbatim. The qualitative data will be
analysed thematically and key quotes extracted which will be used to create a draft item
list. Interviews will be conducted either in person or virtually depending on national
social distancing guidance at the time.
Stage II - Cognitive interviewing Following the creation of a draft item list,
approximately 5 participants from Stage I and 3-5 study naïve patients will undergo
cognitive interviews to ensure that all items are clear and easily understood. The
investigators will also explore patient preferences for the layout of the questionnaire,
time recall and overall application issues. Investigators will aim to include a range of
participants in each of the four groups outlined above.
Stage III - Item reduction and refinement of the draft ACT-PROM. A draft ACT-PROM, FACT-G
and the EORTC PATSATC33 will be administered to approximately 100 participants receiving
ACT. Approximately 50 patients will be asked to repeat the draft PROM approximately one
week later to assess test-retest reliability. Hierarchical item reduction and Rasch
analysis will be used to determine which items should be included in the final ACT-PROM.
Stage IV - Pilot testing The final PROM will be pilot tested with approximately 10
patients to assess its acceptability in the clinic setting. The investigators will aim to
include a minimum of two participants in each of the four groups outlined above.
Criteria for eligibility:
Study pop:
Patients with cancer who are enrolled on a Adoptive Cell Therapy (ACT) trial.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Grant Punnett, MSc
Email:
grant.punnett@nhs.net
Contact backup:
Last name:
Humera Hussein
Email:
humera.hussain3@nhs.net
Start date:
March 28, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
The Christie NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
The Christie NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721365
