CancerEPICNCT03818230
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.
An observational study of Cancer and Depression, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Depression, Anxiety
- What is being tested?
- None (observational study)
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Aug 2018to 15 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred to the Experimental Cancer Medicine Team (ECMT) at The Christie NHS Foundation Trust, to be considered for participation in an early phase clinical trial.
Who may be able to join
- Aged 18 years and older
- Able to provide informed consent
- Are being considered for an early phase clinical trial
Who cannot join
- Patients unable to comprehend English language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
About this study
This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.
- Conditions
- Cancer, Depression, Anxiety, Hope, Psychological Distress
- Being tested
- None (observational study)
- Keywords
- Clinical trials, Early phase clinical trials, Experimental cancer medicine
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (observational study)Other
None (observational study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
Measured: Approximately 14 weeks.
Secondary outcomes (1)
Levels of hope as per the Adult Hope Scale.
Measured: Approximately 14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start21 Aug 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
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.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Natalie Cook, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818230
- Sponsor's protocol ID
- NHS001389
- Acronym
- EPIC
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.
- ClinicalTrials.gov ID
- NCT03818230
- Acronym / sponsor ID
- EPIC / NHS001389
- Conditions
- Cancer, Depression, Anxiety, Hope, Psychological Distress
- Keywords
- Clinical trials, Early phase clinical trials, Experimental cancer medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 28 Jan 2019 (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.
This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred to the Experimental Cancer Medicine Team (ECMT) at The Christie NHS Foundation Trust, to be considered for participation in an early phase clinical trial.
Key inclusion criteria (3 listed)
- Aged 18 years and older
- Able to provide informed consent
- Are being considered for an early phase clinical trial
Key exclusion criteria (1 listed)
- Patients unable to comprehend English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (observational study)None (observational study) | Other | – |
Primary outcome
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
Time frame: Approximately 14 weeks.
1 secondary outcome
Levels of hope as per the Adult Hope Scale.
Time frame: Approximately 14 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Depression, run by University of Manchester 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire. (time frame: Approximately 14 weeks.). 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 24 Mar 2020.