CancerPROMsNCT02507804
A Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)
A study testing Patient diary PROMs and Counselling in people with Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of the study is to design and evaluate a PROMs diary for cancer patients to self report side effects and experiences of their treatment, and thereby create a detailed account of treatment related adverse events and their impact on daily activities to share with the care team. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient diary PROMs and Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to 3 Jun 2019
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients aged 18 or over; no upper age limit.
- Cancer requiring commencement of chemotherapy (any line) with a regime containing at least 6 cycles (of any cycle duration).
- Chemotherapy may include any systematic anti-cancer therapy (i.e. cytotoxic agents, immunotherapy or targeted therapy) provided this is delivered as induction therapy.
- Expectation to complete cycles 1 through 6 of planned therapy.
- The capacity to understand the Patient Information Sheet and provide written informed consent.
- Non English speaking patients may enter the study if an English speaking friend or relative is willing to assist the patient.
- Willingness and ability to comply with study procedures.
- A patient enrolled on a concurrent IMP clinical trial is permitted at the Investigators discretion.
Who cannot join
- Patients who have already commenced therapy for their current disease episode i.e. received at least their first cycle of chemotherapy.
- Patients receiving chemotherapy/ radio-immunotherapy as the sole modality of treatment.
- Patients who have completed induction therapy and due to commence maintenance therapy.
- Uncontrolled medical condition that in the opinion of the Investigator may jeopardise completion of 6 cycles of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre Randomised Controlled Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)
The aim of the study is to design and evaluate a PROMs diary for cancer patients to self report side effects and experiences of their treatment, and thereby create a detailed account of treatment related adverse events and their impact on daily activities to share with the care team.
Read the detailed description
This is a randomised, controlled, single-centred study to compare the quality of Adverse Events (AE) and Concomitant Medication (CM) reporting, patient satisfaction, care experience and quality of life in cancer patients undergoing chemotherapy and managed with/without a diary for Patient Reported Outcome Measures.
164 subjects will be enrolled and randomised in a 1:1 ratio and stratified by line of therapy (first line vs second line or higher line), treatment intent (curative vs palliative) and ECOG performance status (0-1 vs 2-3).
All subjects will receive standard chemotherapy delivered as per institutional practice. They will also receive counselling on monitoring and reporting side effects, medication and experiences as per standard practice.
All subjects will complete a study questionnaire and EQ-5D forms in the Outpatient Department prior to the consultation and delivery of chemotherapy.
Subjects randomised to Arm A will use the PROMs diary to record side effects, medication and experiences associated with cycles 1-6 of chemotherapy. The diary will be reviewed by the study team to collect AE and CM information. AE/CM will be recorded in source documents as per usual practice.
Subjects randomised to the control Arm B will discuss side effects, medication and experiences associated with cycles 1-6 of chemotherapy at clinical consultations as per standard practice. This may include the use of notes, diaries or other methods at their own discretion. Arm B subjects may not use a PROMs diary. The study team will collect and record AE/CM information in the source documentation as per usual practice.
- Conditions
- Cancer
- Being tested
- Patient diary PROMs, Counselling
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient diary PROMsOther
CounsellingOther
| Study group | Role | What they receive |
|---|---|---|
| Arm A diary arm | Experimental | Patients in Arm A are required to complete a patient diary. This will be reviewed by an Investigator at every visit in order to gain Adverse Event and Concomitant Medication information. Receives: Other: Patient diary PROMs |
| Arm B standard of care | Active comparator | Patients will be asked to recall Adverse Events and Concomitant Medication information as standard of care practice would dictate. Receives: Other: Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event and concomitant medication reporting in patient case notes as standard of care
Measured: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
Secondary outcomes (2)
Measure quality of life questionnaire (EQ5D )
Measured: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
Measure patient satisfaction questionnaire
Measured: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion3 Jun 2019
- Study completion3 Jun 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Linton, MBChP MRCP PhD, Principal investigator, Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507804
- Sponsor's protocol ID
- CFTSp099
- Acronym
- PROMs
- Status last verified
- Feb 2023
- First submitted
- 10 Jul 2015
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Randomised Controlled Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)
- ClinicalTrials.gov ID
- NCT02507804
- Acronym / sponsor ID
- PROMs / CFTSp099
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 24 Jul 2015 (estimated)
- 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 aim of the study is to design and evaluate a PROMs diary for cancer patients to self report side effects and experiences of their treatment, and thereby create a detailed account of treatment related adverse events and their impact on daily activities to share with the care team.
Detailed description
This is a randomised, controlled, single-centred study to compare the quality of Adverse Events (AE) and Concomitant Medication (CM) reporting, patient satisfaction, care experience and quality of life in cancer patients undergoing chemotherapy and managed with/without a diary for Patient Reported Outcome Measures.
164 subjects will be enrolled and randomised in a 1:1 ratio and stratified by line of therapy (first line vs second line or higher line), treatment intent (curative vs palliative) and ECOG performance status (0-1 vs 2-3).
All subjects will receive standard chemotherapy delivered as per institutional practice. They will also receive counselling on monitoring and reporting side effects, medication and experiences as per standard practice.
All subjects will complete a study questionnaire and EQ-5D forms in the Outpatient Department prior to the consultation and delivery of chemotherapy.
Subjects randomised to Arm A will use the PROMs diary to record side effects, medication and experiences associated with cycles 1-6 of chemotherapy. The diary will be reviewed by the study team to collect AE and CM information. AE/CM will be recorded in source documents as per usual practice.
Subjects randomised to the control Arm B will discuss side effects, medication and experiences associated with cycles 1-6 of chemotherapy at clinical consultations as per standard practice. This may include the use of notes, diaries or other methods at their own discretion. Arm B subjects may not use a PROMs diary. The study team will collect and record AE/CM information in the source documentation as per usual practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A diary arm | Experimental | Other: Patient diary PROMsPatients in Arm A are required to complete a patient diary. This will be reviewed by an Investigator at every visit in order to gain Adverse Event and Concomitant Medication information. |
| Arm B standard of care | Active comparator | Other: CounsellingPatients will be asked to recall Adverse Events and Concomitant Medication information as standard of care practice would dictate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients aged 18 or over; no upper age limit.
- Cancer requiring commencement of chemotherapy (any line) with a regime containing at least 6 cycles (of any cycle duration).
- Chemotherapy may include any systematic anti-cancer therapy (i.e. cytotoxic agents, immunotherapy or targeted therapy) provided this is delivered as induction therapy.
- Expectation to complete cycles 1 through 6 of planned therapy.
- The capacity to understand the Patient Information Sheet and provide written informed consent.
Key exclusion criteria (4 listed)
- Patients who have already commenced therapy for their current disease episode i.e. received at least their first cycle of chemotherapy.
- Patients receiving chemotherapy/ radio-immunotherapy as the sole modality of treatment.
- Patients who have completed induction therapy and due to commence maintenance therapy.
- Uncontrolled medical condition that in the opinion of the Investigator may jeopardise completion of 6 cycles of treatment.
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 |
|---|---|---|
| Patient diary PROMs | Other | Arm A diary arm |
| Counselling | Other | Arm B standard of care |
Primary outcome
adverse event and concomitant medication reporting in patient case notes as standard of care
Time frame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
2 secondary outcomes
Measure quality of life questionnaire (EQ5D )
Time frame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
Measure patient satisfaction questionnaire
Time frame: Over 6 cycles of chemotherapy/treatment (approximately 18 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 22 Feb 2023.
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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.
Kim Linton, MBChP MRCP PhD principal investigator
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?
A study testing Patient diary PROMs and Counselling in people with 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 8 inclusion and 4 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 22 Feb 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?
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?
adverse event and concomitant medication reporting in patient case notes as standard of care (time frame: Over 6 cycles of chemotherapy/treatment (approximately 18 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 22 Feb 2023.