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

NCT02507804 | Completed

• 1 other identifier: CFTSp099
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• adverse event and concomitant medication reporting in patient case notes as standard of care

  Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)

Secondary Outcomes (2)

• Measure quality of life questionnaire (EQ5D )

  Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)

• Measure patient satisfaction questionnaire

  Over 6 cycles of chemotherapy/treatment (approximately 18 weeks)

Study Arms (2)

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.

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.

Other: Counselling

Interventions

Patient diary PROMs OTHER

Arm A diary arm

Counselling OTHER

Arm B standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kim Linton, MBChP MRCP PhD

  Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 24, 2015
• Study Start: July 1, 2015
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

GB (1)