NCT02507804

A Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)

A Single Centre Randomised Controlled Study to Evaluate a Diary for Patient Reported Outcome Measures (PROMs)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	Patient diary PROMs
OTHER	Counselling

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2015-07-24
• Last updated: 2023-02-22

Locations

1 site across 1 country: United Kingdom