Clinical trial NCT00709813: Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients
Official title: Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lymphoma
Leukemia
Stem Cell Transplantation
Keywords: Symptom management
Cancer
Patient-centered care
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2008-07-03
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. CHOICE is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. In this randomized clinical trial at Rikshospitalet- Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for care at in-and outpatient visits during treatment and rehabilitation. In the experimental group this information was shared with physicians an nurses for subsequent care planning, but not in the control group.

This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom relief, patients' needs for care over time and patient satisfaction;(2) analyzed how patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and type/stage of treatment, education, depression, health related quality of life, and social support, repeated measurement models were used to test differences and variations in outcome variables within and between groups and over time.

Detailed description: as above

Eligibility criteria: Inclusion Criteria:

* Starting treatment for a newly diagnosed acute myelogenous leukemia (AML), lymphatic leukemia (ALL), Hodgkin or non-Hodgkin lymphoma, or
* starting treatment for a recurrence of the disease;
* starting treatment with allogenous or autologous Stem Cell Transplantation (SCT).
* above 18 years of age.

Exclusion Criteria:

* having received radiation on the brain

Primary outcomes:
measure: Physicians' and nurses' symptom-related chart entries in patients' records
timeFrame: In-patient episodes of care
measure: Symptom distress over time
timeFrame: Repeated episodes of care
measure: Patients' prioritized needs for care over time
timeFrame: Repeated episodes of care
Secondary outcomes:
measure: Patient satisfaction
timeFrame: End of study
measure: Care providers' satisfaction
timeFrame: End of study
measure: Preferences for participation in decision making- and changes over time
timeFrame: Baseline, and at completion of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Rikshospitalet-Radiumhospitalet
name: Cornelia M Ruland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruland CM. Clinicians' perceived usefulness of a support system for patient-centered cancer care. Stud Health Technol Inform. 2006;124:624-30.
citation: Ruland CM, Bakken S, Roislien J. Reliability and validity issues related to interactive tailored patient assessments: a case study. J Med Internet Res. 2007 Aug 1;9(3):e22. doi: 10.2196/jmir.9.3.e22.