Clinical trial · Interventional
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)
NCT02507804CI-TRIAL-00064157PROMscompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counselling | Other | — | UNRESOLVED |
| Patient diary PROMs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A diary arm
- description
- 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.
- interventionNames
- Other: Patient diary PROMs
- type
- ACTIVE_COMPARATOR
- label
- Arm B standard of care
- description
- Patients will be asked to recall Adverse Events and Concomitant Medication information as standard of care practice would dictate.
- interventionNames
- Other: Counselling
Primary outcomes (1)
- measure
- adverse event and concomitant medication reporting in patient case notes as standard of care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.