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

July 3, 2011 updated by: Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

as above

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physicians' and nurses' symptom-related chart entries in patients' records
Time Frame: In-patient episodes of care
In-patient episodes of care
Symptom distress over time
Time Frame: Repeated episodes of care
Repeated episodes of care
Patients' prioritized needs for care over time
Time Frame: Repeated episodes of care
Repeated episodes of care

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: End of study
End of study
Care providers' satisfaction
Time Frame: End of study
End of study
Preferences for participation in decision making- and changes over time
Time Frame: Baseline, and at completion of treatment
Baseline, and at completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

The Research Council of Norway

Investigators

  • Principal Investigator: Cornelia M Ruland, PhD, Rikshospitalet-Radiumhospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (ESTIMATE)

July 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCN 154739/320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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