Clinical trial NCT01833637: Electronic Patient Reported Symptom Assessment
Official title: Electronic Patient Reported Symptom Assessment: A Pilot Study Introducing Advanced Care Planning and Palliative Care to Hospitalized Women With Advanced Gynecologic, Breast, Thoracic, or Gastrointestinal Malignancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Breast Cancer
Thoracic Cancer
Gastrointestinal Cancer
Keywords: Advanced Care Planning
Palliative Care
Women
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess whether using computerized screening questions can improve how well we manage symptoms related to cancer and cancer treatments. Advance care planning is a process in which teams of experts assist in with treatment plans, managing pain and other symptoms, emotional issues, and end of life issues. With advances in technology, it is now possible to get the patient's feedback directly and more often. It is thought that repeated questionnaires completed by the patient will provide a better and more accurate measure of the patient's needs and experiences but this has not been tested. This study is designed to learn if using a computerized assessment repeatedly is better than standard planning techniques.


Eligibility criteria: Inclusion Criteria:

1. Women who have a diagnosis of metastatic breast, gynecologic, thoracic, or gastrointestinal malignancy. Women diagnosed with non-solid organ tumors (i.e., lymphoma, leukemia) will be excluded as their symptom profile in advanced/metastatic disease is dissimilar.
2. Reason for admission must be for symptom management from cancer or cancer therapy.
3. Patients must be age 18 or older.
4. Only patients cared for at the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) will be eligible for this small pilot study.
5. Patients must not be enrolled in hospice care.
6. Patients must have a performance status 0-3 (ECOG scale).
7. Patients must be alert and oriented to time, place, and person. Must be able to answer questions.
8. Patients must be able to speak, read, and communicate in English.
9. Patients must have a signed consent and authorization for research and be amenable to be followed for outcomes/response throughout and after hospitalization.

Exclusion Criteria:

-

Primary outcomes:
measure: Identify perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.
timeFrame: 3 years
measure: Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.
timeFrame: 3 years
Secondary outcomes:
measure: Examine scores of electronic reported symptom assessment combined with targeted intervention to see it it improves symptoms scores over the course of hospitalization.
timeFrame: 3 years
measure: Use electronic symptom scoring, targeted intervention, and sequential assessments every 24 hours to assess the impact on length of hospitalization and readmissions.
timeFrame: 3 years
measure: Assess level of understanding about advance care planning in both the control and intervention group.
timeFrame: 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emily Berry, MD
role: PRINCIPAL_INVESTIGATOR
References: