NCT00857103

Brief Summary

This interdisciplinary international research collaboration will test effects of Choice, a computer-assisted, interactive support system designed to help cancer patients communicate their symptoms and preferences, and clinicians in incorporating this information into patient care. In this pretest-post test clinical trial with 200 leukemia and lymphoma patients we will: 1) Test effects of Choice when integrated into routine clinical practice on: patient-provider communication, documented patient care, anxiety and patient satisfaction; 2) analyze relationships among the above variables and explore differences in these relationships between groups; 3) analyze group differences in communication style in terms of instrumental and affective behavior, content, participation, initiative and person addressed; and 4) investigate the extent of the time requirements when using Choice in clinical practice, perceived usefulness and ease of use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable lymphoma

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

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

August 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

March 5, 2009

Last Update Submit

June 14, 2013

Conditions

Keywords

computer supportpatient-provider communicationpatient-centered carecancer

Outcome Measures

Primary Outcomes (3)

  • Patient satisfaction

    one point assessment

  • Anxiety

    one point assessment

  • communication

    one point assessment

Study Arms (2)

1

NO INTERVENTION

Standard care

2

EXPERIMENTAL

Use of Choice intervention to support consultations

Behavioral: CHOICE

Interventions

CHOICEBEHAVIORAL

Use of Choice support system as preparation for patient consultations

Also known as: Standard care
2

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with leukemia or lymphoma and in treatment or follow up after treatment within last 12 months.
  • Being able to understand, speak and write Norwegian.
  • Informed consent

You may not qualify if:

  • If clinician know patient will receive bad news regarding outcome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet University Hospital

Oslo, Oslo County, 0027, Norway

Location

Related Publications (1)

  • Heyn L, Ruland CM, Finset A. Effects of an interactive tailored patient assessment tool on eliciting and responding to cancer patients' cues and concerns in clinical consultations with physicians and nurses. Patient Educ Couns. 2012 Feb;86(2):158-65. doi: 10.1016/j.pec.2011.04.024. Epub 2011 May 17.

MeSH Terms

Conditions

LymphomaNeoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations