NCT00709813

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Dec 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
Last Updated

July 6, 2011

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

July 2, 2008

Last Update Submit

July 3, 2011

Conditions

CancerLymphomaLeukemiaStem Cell Transplantation

Keywords

Symptom managementCancerPatient-centered care

Outcome Measures

Primary Outcomes (3)

  • Physicians' and nurses' symptom-related chart entries in patients' records

    In-patient episodes of care

  • Symptom distress over time

    Repeated episodes of care

  • Patients' prioritized needs for care over time

    Repeated episodes of care

Secondary Outcomes (3)

  • Patient satisfaction

    End of study

  • Care providers' satisfaction

    End of study

  • Preferences for participation in decision making- and changes over time

    Baseline, and at completion of treatment

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL
Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))

Interventions

Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))BEHAVIORAL

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • having received radiation on the brain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

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

    PMID: 17108586BACKGROUND

  • 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.

    PMID: 17942384RESULT

MeSH Terms

Conditions

NeoplasmsLymphomaLeukemia

Interventions

NursesInosine Triphosphatase

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and ServicesPyrophosphatasesAcid Anhydride HydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Cornelia M Ruland, PhD

    Rikshospitalet-Radiumhospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 3, 2008

Study Start

December 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 6, 2011

Record last verified: 2009-03