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

Study Overview
=================
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.

Detailed Description
-----------------
as above

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

Conditions
-----------------
Cancer, Lymphoma, Leukemia, Stem Cell Transplantation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br> | Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptom management, Cancer, Patient-centered care