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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT02050490
Collaborator
Algemeen Ziekenhuis Maria Middelares (Other), Flemish League Against Cancer (Other), Onze Lieve Vrouw Hospital (Other)
250
Enrollment
1
Location
23
Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Sep 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Before group, no diary
    After group, with symptom diary

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    Other Outcome Measures

    1. symptom care [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital Maria Middelares Ghent Belgium

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven
    • Algemeen Ziekenhuis Maria Middelares
    • Flemish League Against Cancer
    • Onze Lieve Vrouw Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Annemarie Coolbrandt, Clinical Nurse Specialist Oncology, Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT02050490
    Other Study ID Numbers:
    • B322201419701
    First Posted:
    Jan 30, 2014
    Last Update Posted:
    Nov 18, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Vomiting
    Anorexia

    Study Results

    No Results Posted as of Nov 18, 2014