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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02050490

Enrollment

236

Registered

2014-01-30

Start date

2014-01-31

Completion date

2016-12-31

Last updated

2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia, Etcetera, Nausea, Pain, Vomiting

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Belgium

Outcome results