Clinical trial NCT02507804: A Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)
Official title: A Single Centre Randomised Controlled Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: adverse event and concomitant medication reporting in patient case notes as standard of care
timeFrame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
Secondary outcomes:
measure: Measure quality of life questionnaire (EQ5D )
timeFrame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
measure: Measure patient satisfaction questionnaire
timeFrame: Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
Study officials:
affiliation: Christie NHS Foundation Trust
name: Kim Linton, MBChP MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References: