NCT02050490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2023

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

January 27, 2014

Last Update Submit

January 26, 2023

Conditions

NauseaVomitingPainAnorexiaEtcetera

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • symptom severity

    T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1), T4 (cycle 5, day 1)

Other Outcomes (1)

  • symptom care

    T1 (cycle 1, day 1), T2 (cycle 2, day 1), T3 (cycle 3, day 1)

Study Arms (2)

Before group, no diary

After group, with symptom diary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Adult (\>18) patients with (any type of) cancer treated with chemotherapy
  • Understanding Dutch
  • Being able to sign Informed consent

You may not qualify if:

  • More than 3 lines of chemotherapy treatment in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Maria Middelares

Ghent, Belgium

Location

MeSH Terms

Conditions

NauseaVomitingPainAnorexia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

January 27, 2023

Record last verified: 2016-10

Locations

BE(1)