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Completed

NCT Number: NCT02050490

Effect of a Symptom Diary on Symptom Care and Symptom Burden in 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.

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Key information

Conditions

Nausea Anorexia Etcetera Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Maria Middelares

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2014
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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