CancerNCT05721365
The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
An observational study of Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- How many people
- 142 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cancer who are enrolled on a Adoptive Cell Therapy (ACT) trial.
Who may be able to join
- 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
Who cannot join
- Aged under 16
- Unable to understand and communicate in the English language
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Grant Punnett, MSc, grant.punnett@nhs.net
Humera Hussein, humera.hussain3@nhs.net
About this study
The goals of this observational study is to
- To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
- 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.
Read the detailed description
The goals of this observational study is to
- To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
- 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Responses are collected using 27 items on a 5 point likert type scale. Total score ranges between 0 and 108 with higher scores indicating higher quality of life. Collected to determine construct validity of the draft PROM.
Measured: 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)
Satisfaction with cancer care core questionnaire. The questionnaire contains three sections addressing the perceived quality of care provided by doctors, nurses/radiotherapy technicians, and services/care organisation. Responses are collected using 33 items on a 5 point likert type scale. Collected to determine construct validity of the draft PROM.
Measured: Completed during stage 3 of the study at baseline with the draft PROM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start28 Mar 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Fiona Thistlethwaite, PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721365
- Sponsor's protocol ID
- 22_CPCR_32
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
- ClinicalTrials.gov ID
- NCT05721365
- Acronym / sponsor ID
- 22_CPCR_32
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this observational study is to
- To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
- 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
- To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cancer who are enrolled on a Adoptive Cell Therapy (ACT) trial.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Aged under 16
- Unable to understand and communicate in the English language
- Unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline
Time frame: 100 participants receiving ACT will complete the PROM upon recruitment,
Draft PROM pilot tested in stage 3 of the study. Content is determined in the first 2 stages of the study.
Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) 7 days post baseline
Time frame: 50 of the 100 participants completing the PROM at baseline will repeat the PROM 1 week later.
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.
2 secondary outcomes
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: 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)
Time frame: Completed during stage 3 of the study at baseline with the draft PROM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Thistlethwaite, PhD principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grant Punnett, MSc (+447427143635, grant.punnett@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline (time frame: 100 participants receiving ACT will complete the PROM upon recruitment,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.