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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Chemotherapy; Cancer

Treatments: Behavioral: Nurse support and selfmanagement intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02298972

B322201422086

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Comparison group

No Intervention group

Description:

The comparison group will receive standard care.

Intervention group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nurse support and selfmanagement intervention