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Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00709813
First received: July 2, 2008
Last updated: July 3, 2011
Last verified: March 2009
History of Changes

July 2, 2008
July 3, 2011
December 2003
December 2005   (final data collection date for primary outcome measure)
  • Physicians' and nurses' symptom-related chart entries in patients' records [ Time Frame: In-patient episodes of care ] [ Designated as safety issue: No ]
  • Symptom distress over time [ Time Frame: Repeated episodes of care ] [ Designated as safety issue: No ]
  • Patients' prioritized needs for care over time [ Time Frame: Repeated episodes of care ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00709813 on ClinicalTrials.gov Archive Site
  • Patient satisfaction [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Care providers' satisfaction [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Preferences for participation in decision making- and changes over time [ Time Frame: Baseline, and at completion of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients
Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial

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.

as above
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Cancer
  • Lymphoma
  • Leukemia
  • Stem Cell Transplantation
Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))
Both groups used CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)for symptom assessments at in- and outpatient visits during and up-to nine months after treatment. In the intervention group physicians and nurses had assessment summaries available for care planning, displaying patients' symptoms, problems and concerns in rank-order of their needs for care. In the control group assessments were not available to care providers at any time.
  • No Intervention: 1
  • Experimental: 2
    Intervention: Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00709813
RCN 154739/320
No
Cornelia M. Ruland, Professor, Rikshospitalet-Radiumhospitalet HF
Oslo University Hospital
The Research Council of Norway
Principal Investigator: Cornelia M Ruland, PhD Rikshospitalet-Radiumhospitalet
Oslo University Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP