Effect of Interactive Tailored Assessment on Patient-Provider Communication - Full Text View

Sponsors and Collaborators:	Rikshospitalet HF The Research Council of Norway
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00857103

Purpose

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-posttest 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 adressed; and 4) investigate the extent of the time requirements when using Choice in clinical practice, perceived usefulness and ease of use.

Condition	Intervention
Lymphoma	Behavioral: CHOICE

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Improving Patient-Provider Communication in Cancer Care

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

Patient satisfaction [ Time Frame: one point assessment ] [ Designated as safety issue: No ]
Anxiety [ Time Frame: one point assessment ] [ Designated as safety issue: No ]
communication [ Time Frame: one point assessment ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Standard care
2: Experimental Use of Choice intervention to support consultations	Behavioral: CHOICE Use of Choice support system as preparation for patient consultations

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-posttest 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-centred; (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-centred care and physical, emotional and psycho-social well-being of cancer patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosised 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857103

Locations

Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027

Sponsors and Collaborators

Rikshospitalet HF

The Research Council of Norway

More Information

No publications provided

Responsible Party:	Oslo University Hospital ( Cornelia M. Ruland )
Study ID Numbers:	RCN 177500/V50
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857103 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Rikshospitalet HF:

computer support
patient-provider communication
patient-centered care
cancer

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on September 10, 2009