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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, Chemotherapy

Intervention / Treatment
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* Behavioral: Nurse support and selfmanagement intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Comparison group<br>The comparison group will receive standard care. | |
| Active Comparator: Intervention group<br>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. | Behavioral: Nurse support and selfmanagement intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall symptom distress | Summed symptom distress as self-reported on the Symptom Burden Questionnaire | Longitudinal, during first 3 months after start of treatment | 
| Overall symptom severity | Summed symptom severity as self-reported on the Symptom Burden Questionnaire | Longitudinal, during first 3 months after start of treatment | 

Secondary Outcome Measures

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