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

NCT05721365 | Unknown DMC

• 1 other identifier: 22_CPCR_32
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this observational study is to

1. 1.To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
2. 2.To develop guidelines/recommendations for the use of PROMs in ACT trials

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline

  Draft PROM pilot tested in stage 3 of the study. Content is determined in the first 2 stages of the study.

  100 participants receiving ACT will complete the PROM upon recruitment,

• Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) 7 days post baseline

  Draft PROM pilot tested in stage 3 of the study. Content is determined in the first 2 stages of the study. This will be compared to baseline to determine test-retest reliability.

  50 of the 100 participants completing the PROM at baseline will repeat the PROM 1 week later.

Secondary Outcomes (2)

• Functional Assessment of Cancer Therapy - General (FACT-G)

  Completed during stage 3 of the study at baseline with the draft PROM.

• European Organisation for Research and Treatment of Cancer Satisfaction with Cancer Care Core Questionnaire (EORTC PATSATC33)

  Completed during stage 3 of the study at baseline with the draft PROM.

Study Arms (4)

Pre-Infusion

Participants prior to commencing Adoptive Cell Therapy (ACT).

Acute

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

Sub-acute

Up to 12 months post ACT.

Long term follow up

From 12 months post ACT onwards

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer who are enrolled on a Adoptive Cell Therapy (ACT) trial.

You may qualify if:

• Patients who are enrolled on Adoptive Cell Therapy (ACT) trial
• Aged over 16 (no upper age limit)
• Ability to understand and communicate in the English language
• Able to provide written informed consent

You may not qualify if:

• Aged under 16
• Unable to understand and communicate in the English language
• Unable to provide written informed consent

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Fiona Thistlethwaite, PhD

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grant Punnett, MSc

CONTACT

+447427143635; grant.punnett@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 10, 2023
• Study Start: March 28, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)