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

October 24, 2016 updated by: Annemarie Coolbrandt, Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison group
The comparison group will receive standard care.
Active Comparator: Intervention group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall symptom distress
Time Frame: Longitudinal, during first 3 months after start of treatment
Summed symptom distress as self-reported on the Symptom Burden Questionnaire
Longitudinal, during first 3 months after start of treatment
Overall symptom severity
Time Frame: Longitudinal, during first 3 months after start of treatment
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
Time Frame: Day 43 of treatment (+/- 1 week)
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
Time Frame: Day 43 of treatment (+/- 1 week)
Outcome will be measured by a self-report questionnaire
Day 43 of treatment (+/- 1 week)
Total self-care score
Time Frame: 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
Day 85 of treatment (+/- 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Flemish League Against Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • B322201422086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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