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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298972
• Other study ID #: B322201422086
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: October 24, 2016
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Chemotherapy

Intervention

Behavioral:
• Nurse support and selfmanagement intervention

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Flemish League Against Cancer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall symptom distress	Summed symptom distress as self-reported on the Symptom Burden Questionnaire	Longitudinal, during first 3 months after start of treatment	No
Primary	Overall symptom severity	Summed symptom severity as self-reported on the Symptom Burden Questionnaire	Longitudinal, during first 3 months after start of treatment	No
Secondary	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)	No
Secondary	Total outcome expectations score	Outcome will be measured by a self-report questionnaire	Day 43 of treatment (+/- 1 week)	No
Secondary	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)	No