- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02298972
Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer
October 24, 2016 updated by: Annemarie Coolbrandt, Universitaire Ziekenhuizen KU Leuven
This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy.
Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will evaluate the effect of this nursing intervention on overall symptom distress (primary outcome) and other measures of symptom burden, self-efficacy, outcome expectations and self-care.
By conducting sem-structured interviews with some participants of the intervention group, we will study the patient experience of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium
- UZ Leuven
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients starting first line treatment with (intravenous) chemotherapy
- Ambulatory patients or patients who receive their treatment during short hospital stays
- Regardless of type of cancer, treatment or treatment intention (curative or palliative)
- Who understand sufficiently Dutch to fill out questionnaires
- Who sign informed consent for their participation in the study
Exclusion Criteria:
- Oral anticancer treatment
- Concomitant chemoradiotherapy
- Breast cancer patients who receive nurse counseling throughout their therapy
- Experimental therapy in the context of a clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Comparison group
The comparison group will receive standard care.
|
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Active Comparator: Intervention group
After completion of the comparison group, new patients starting chemotherapy treatment will be offered this study.
Study participants will receive the nurse support and selfmanagement intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall symptom distress
Time Frame: Longitudinal, during first 3 months after start of treatment
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Summed symptom distress as self-reported on the Symptom Burden Questionnaire
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Longitudinal, during first 3 months after start of treatment
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Overall symptom severity
Time Frame: Longitudinal, during first 3 months after start of treatment
|
Summed symptom severity as self-reported on the Symptom Burden Questionnaire
|
Longitudinal, during first 3 months after start of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total self-efficacy score
Time Frame: Day 43 of treatment (+/- 1 week)
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Outcome will be measured by a self-report questionnaire: shortened version of the Cancer Behavior Inventory
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Day 43 of treatment (+/- 1 week)
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Total outcome expectations score
Time Frame: Day 43 of treatment (+/- 1 week)
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Outcome will be measured by a self-report questionnaire
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Day 43 of treatment (+/- 1 week)
|
Total self-care score
Time Frame: Day 85 of treatment (+/- 1 week)
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Outcome will be measured by a self-report questionnaire: shortened version of the Leuven- Patient Self-care during chemotherapy scale
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Day 85 of treatment (+/- 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
November 17, 2014
First Submitted That Met QC Criteria
November 21, 2014
First Posted (Estimate)
November 24, 2014
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- B322201422086
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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