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

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ClinicalTrials.gov Identifier: NCT02298972
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Flemish League Against Cancer
Information provided by (Responsible Party):
Annemarie Coolbrandt, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Cancer Chemotherapy Behavioral: Nurse support and selfmanagement intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Total outcome expectations score [ Time Frame: Day 43 of treatment (+/- 1 week) ]
    Outcome will be measured by a self-report questionnaire

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298972


Locations
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Belgium
UZ Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Flemish League Against Cancer

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Responsible Party: Annemarie Coolbrandt, Clinical Nurse Specialist oncology, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02298972     History of Changes
Other Study ID Numbers: B322201422086
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016