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NCT Number: NCT02298972

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

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.

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Key information

Conditions

Cancer Chemotherapy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse support and selfmanagement intervention

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Flemish League Against Cancer

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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