Effect of Interactive Tailored Assessment on Patient-provider Communication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857103
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : June 17, 2013
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphoma Behavioral: CHOICE Not Applicable

Detailed Description:
Improving shared decision making (SDM), patient-provider communication and incorporating patients' illness experiences and preferences into patient care are high priority health policy goals. However, this is difficult to accomplish without methods and systems that assist patients in sharing their illness experiences and clinicians in integrating this information into patient care. Choice is a computer-assisted, interactive communication and support system for cancer patients designed for this purpose. This interdisciplinary, international research collaboration will test effects of Choice in a pretest-post test clinical trial with 200 leukemia and lymphoma patients. We hypothesize that when patients use Choice for symptom and preference assessments and this information is provided to their clinicians to support consultations in routine practice, (1) patient-provider communication will be more patient-centered; (2) documented care will be more congruent with patients' reported symptoms and preferences; (3) patients will experience lower levels of anxiety and stress during consultations; and (4) they will be more satisfied with the consultation than the "usual care" control group. To better understand the mechanisms by which these effects occur, we will investigate relationships between communication style, documented patient care, anxiety and satisfaction; and explore time requirements, perceived usefulness and ease of use of Choice by patients and clinicians. Controlling for gender, age, diagnosis and type/stage of treatment, analyses of covariance and repeated measurement models will be primarily used for hypotheses testing, correlations and descriptive statistics to answer research questions. This study will contribute to new technologies to support SDM and patient-provider partnerships in health care that can significantly improve patient-provider communication, patient-centered care and physical, emotional and psycho-social well-being of cancer patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Patient-Provider Communication in Cancer Care
Study Start Date : August 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Standard care
Experimental: 2
Use of Choice intervention to support consultations
Behavioral: CHOICE
Use of Choice support system as preparation for patient consultations
Other Name: Standard care

Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: one point assessment ]
  2. Anxiety [ Time Frame: one point assessment ]
  3. communication [ Time Frame: one point assessment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857103

Rikshospitalet University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oslo University Hospital Identifier: NCT00857103     History of Changes
Other Study ID Numbers: RCN 177500/V50
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by Oslo University Hospital:
computer support
patient-provider communication
patient-centered care