The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting

The Christie NHS Foundation Trust

Status: Enrolling

Conditions: Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05721365

22_CPCR_32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

142 participants in 4 patient groups

Pre-Infusion

Description:

Participants prior to commencing Adoptive Cell Therapy (ACT).

Acute

Description:

Participants either receiving ACT or up to 30 days post treatment.

Sub-acute

Description:

Up to 12 months post ACT.

Long term follow up

Description:

From 12 months post ACT onwards