Study to Test a Computer-Assisted Support System to Improve Patient-Centered Care and Symptom Relief in Cancer Patients - Full Text View

Sponsors and Collaborators:	Rikshospitalet HF The Research Council of Norway
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00709813

Purpose

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.

Condition	Intervention
Cancer Lymphoma Leukemia Stem Cell Transplantation	Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Palliative Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	145
Study Start Date:	December 2003
Study Completion Date:	January 2006
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention
2: Experimental	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.

Arms

Assigned Interventions

1: No Intervention

2: Experimental

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.

Detailed Description:

as above

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709813

Sponsors and Collaborators

Rikshospitalet HF

The Research Council of Norway

Investigators

Principal Investigator:

Cornelia M Ruland, PhD

Rikshospitalet-Radiumhospitalet

More Information

Publications of Results:

Ruland CM, Bakken S, Røislien J. Reliability and validity issues related to interactive tailored patient assessments: a case study. J Med Internet Res. 2007 Aug 1;9(3):e22.

Other Publications:

Ruland CM. Clinicians' perceived usefulness of a support system for patient-centered cancer care. Stud Health Technol Inform. 2006;124:624-30.

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Cornelia M. Ruland, Professor )
Study ID Numbers:	RCN 154739/320
Study First Received:	July 2, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00709813
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Rikshospitalet HF:

Symptom management
Cancer
Patient-centered care

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009