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Clinical Trials/NCT01833637
NCT01833637
Completed
Not Applicable

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.

Northwestern University1 site in 1 country6 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gynecologic Cancer
Sponsor
Northwestern University
Enrollment
6
Locations
1
Primary Endpoint
Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Berry

Physician

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Reason for admission must be for symptom management from cancer or cancer therapy.
  • Patients must be age 18 or older.
  • Only patients cared for at the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) will be eligible for this small pilot study.
  • Patients must not be enrolled in hospice care.
  • Patients must have a performance status 0-3 (ECOG scale).
  • Patients must be alert and oriented to time, place, and person. Must be able to answer questions.
  • Patients must be able to speak, read, and communicate in English.
  • 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

  • Not provided

Outcomes

Primary Outcomes

Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.

Time Frame: 3 years

We will compare the symptom scores of the control and the intervention groups to determine if the overall symptom burden scores are lower and patient satisfaction scores are higher in the group who receive targeted intervention combined with education.

Identify perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.

Time Frame: 3 years

We will compare the symptom scores of the control and the intervention groups to determine if the overall symptom burden scores are lower and patient satisfaction scores are higher in the group who receive targeted intervention combined with education.

Secondary Outcomes

  • Assess level of understanding about advance care planning in both the control and intervention group.(3 years)
  • Examine scores of electronic reported symptom assessment combined with targeted intervention to see it it improves symptoms scores over the course of hospitalization.(3 years)
  • Use electronic symptom scoring, targeted intervention, and sequential assessments every 24 hours to assess the impact on length of hospitalization and readmissions.(3 years)

Study Sites (1)

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