- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507804
A Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs) (PROMs)
A Single Centre Randomised Controlled Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susan Neeson, Bsc
- Phone Number: +441619187225
- Email: Susan.Neeson@christie.nhs.uk
Study Contact Backup
- Name: Clare Day, Msc
- Phone Number: +441619187516
- Email: Clare.Day@christie.nhs.uk
Study Locations
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Manchester, United Kingdom, M20 4BX
- Christie NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A diary arm
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.
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Active Comparator: Arm B standard of care
Patients will be asked to recall Adverse Events and Concomitant Medication information as standard of care practice would dictate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure quality of life questionnaire (EQ5D )
Time Frame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
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Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
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Measure patient satisfaction questionnaire
Time Frame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
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Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Kim Linton, MBChP MRCP PhD, Christie NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CFTSp099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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