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

Cancer Clinical Trial

Official title:

Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709813
• Other study ID #: RCN 154739/320
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: July 3, 2011
• Start date: December 2003
• Est. completion date: December 2005

Study information

• Verified date: March 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

as above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Leukemia
• Lymphoma
• Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Research Council of Norway

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physicians' and nurses' symptom-related chart entries in patients' records		In-patient episodes of care	No
Primary	Symptom distress over time		Repeated episodes of care	No
Primary	Patients' prioritized needs for care over time		Repeated episodes of care	No
Secondary	Patient satisfaction		End of study	No
Secondary	Care providers' satisfaction		End of study	No
Secondary	Preferences for participation in decision making- and changes over time		Baseline, and at completion of treatment	No