Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer

Not Applicable

Completed

• Conditions: Chemotherapy; Cancer

• Registration Number: NCT02298972
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall symptom distress	Longitudinal, during first 3 months after start of treatment	Summed symptom distress as self-reported on the Symptom Burden Questionnaire
Overall symptom severity	Longitudinal, during first 3 months after start of treatment	Summed symptom severity as self-reported on the Symptom Burden Questionnaire

Secondary Outcome Measures

Name	Time	Method
Total self-efficacy score	Day 43 of treatment (+/- 1 week)	Outcome will be measured by a self-report questionnaire: shortened version of the Cancer Behavior Inventory
Total outcome expectations score	Day 43 of treatment (+/- 1 week)	Outcome will be measured by a self-report questionnaire
Total self-care score	Day 85 of treatment (+/- 1 week)	Outcome will be measured by a self-report questionnaire: shortened version of the Leuven- Patient Self-care during chemotherapy scale

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium