Pain Clinical Trial
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
| NCT number | NCT02050490 |
| Other study ID # | B322201419701 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | December 2016 |
| Verified date | October 2016 |
| Source | Universitaire Ziekenhuizen KU Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 236 |
| Est. completion date | December 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | General Hospital Maria Middelares | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | Algemeen Ziekenhuis Maria Middelares, Flemish League Against Cancer, Onze Lieve Vrouw Hospital |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | symptom care | 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) | |
| Primary | symptom distress | 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 | symptom severity | 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) |
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