Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer
1 other identifier
interventional
143
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Oct 2014
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 26, 2016
October 1, 2016
9 months
November 17, 2014
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Total self-efficacy score
Day 43 of treatment (+/- 1 week)
Total outcome expectations score
Day 43 of treatment (+/- 1 week)
Total self-care score
Day 85 of treatment (+/- 1 week)
Study Arms (2)
Comparison group
NO INTERVENTIONThe comparison group will receive standard care.
Intervention group
ACTIVE COMPARATORAfter 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Oral anticancer treatment
- Concomitant chemoradiotherapy
- Breast cancer patients who receive nurse counseling throughout their therapy
- Experimental therapy in the context of a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Belgium
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Nurse Specialist oncology
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 24, 2014
Study Start
October 1, 2014
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
October 26, 2016
Record last verified: 2016-10