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

Not Applicable

Completed

• Conditions: Chemotherapy; Cancer
• Interventions: Behavioral: Nurse support and selfmanagement intervention

• 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

Arm && Interventions

Group	Intervention	Description
Intervention group	Nurse support and selfmanagement intervention	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.

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