NauseaNCT02050490
Effect of a Symptom Diary on Symptom Care and Symptom Burden in Patients Treated With Chemotherapy: a Before-and-after-study
An observational study of Nausea and Vomiting, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 236 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18) patients with (any type of) cancer treated with chemotherapy
Who may be able to join
- Adult (>18) patients with (any type of) cancer treated with chemotherapy
- Understanding Dutch
- Being able to sign Informed consent
Who cannot join
- More than 3 lines of chemotherapy treatment in the past
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Medical subject headings
- Nausea, Vomiting, Pain, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before group, no diary | Not described | |
| After group, with symptom diary | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom distress
for each of 9 symptoms: how distressing was the symptom perceived by the patient? (ordinal variable)
Measured: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)
Secondary outcomes (1)
symptom severity
for each of 9 symptoms: how severe was the symptom? (ordinal variable)
Measured: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, Flemish League Against Cancer, Onze Lieve Vrouw Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050490
- Sponsor's protocol ID
- B322201419701
- Status last verified
- Oct 2016
- First submitted
- 27 Jan 2014
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02050490
- Acronym / sponsor ID
- B322201419701
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, Flemish League Against Cancer, Onze Lieve Vrouw Hospital
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before group, no diary | – | – |
| After group, with symptom diary | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18) patients with (any type of) cancer treated with chemotherapy
Key inclusion criteria (3 listed)
- Adult (>18) patients with (any type of) cancer treated with chemotherapy
- Understanding Dutch
- Being able to sign Informed consent
Key exclusion criteria (1 listed)
- More than 3 lines of chemotherapy treatment in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
symptom severity
Time frame: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom distress (time frame: T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.