Effect of a Symptom Diary on Symptom Care and Symptom Burden in Patients Treated With Chemotherapy: a Before-and-after-study

Completed

• Conditions: Nausea; Etcetera; Pain; Vomiting; Anorexia

• Registration Number: NCT02050490
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

This study investigates whether the implementation of a symptom diary for reporting and communicating chemotherapy-related symptoms improves symptom care and decreases symptom burden in adult patients treated with chemotherapy.

The hypothesis is studied using a before-and-after design. First, symptom care and symptom burden will be observed in a sample of patients not being offered a symptom diary. Next, the symptom diary will be implemented at the participating hospital and symptom care and symptom burden will now be observed in a new sample of chemotherapy patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2016-08
• Status Verified: 2016-10
• Study Completion: 2016-12
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Adult (>18) patients with (any type of) cancer treated with chemotherapy
• Understanding Dutch
• Being able to sign Informed consent

Exclusion Criteria

• More than 3 lines of chemotherapy treatment in the past

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptom distress	T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)	for each of 9 symptoms: how distressing was the symptom perceived by the patient? (ordinal variable)

Secondary Outcome Measures

Name	Time	Method
symptom severity	T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)	for each of 9 symptoms: how severe was the symptom? (ordinal variable)

Trial Locations

Locations (1)

General Hospital Maria Middelares; 🇧🇪 Ghent, Belgium