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

January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

Effect of the Implementation of a Symptom Diary on the Symptom Care Received and the Symptom Burden Experienced by Adult Cancer Patients Treated With Chemotherapy: A Before-and-after-study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • General Hospital Maria Middelares

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult (>18) patients with (any type of) cancer treated with chemotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Before group, no diary
After group, with symptom diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom distress
Time Frame: 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)
T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom severity
Time Frame: 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)
T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom care
Time Frame: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1)
binary variable expressing whether the patient has received care (either medication or advice) to help with the symptom
T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Onze Lieve Vrouw Hospital
Algemeen Ziekenhuis Maria Middelares
Flemish League Against Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B322201419701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe