Clinical trial NCT05721365: The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
Official title: The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-02-10
Enrollment: 142
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer who are enrolled on a Adoptive Cell Therapy (ACT) trial.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline
timeFrame: 100 participants receiving ACT will complete the PROM upon recruitment,
measure: Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) 7 days post baseline
timeFrame: 50 of the 100 participants completing the PROM at baseline will repeat the PROM 1 week later.
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Completed during stage 3 of the study at baseline with the draft PROM.
measure: European Organisation for Research and Treatment of Cancer Satisfaction with Cancer Care Core Questionnaire (EORTC PATSATC33)
timeFrame: Completed during stage 3 of the study at baseline with the draft PROM.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Fiona Thistlethwaite, PhD
role: PRINCIPAL_INVESTIGATOR
References: