Electronic Patient Reported Symptom Assessment

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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Gynecologic Cancer; Thoracic Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Other: APN Intervention

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Arm A: Control Group; Patients randomized to the control group will be asked to fill out a patient symptom questionnaire using an iPad at the time of registration and then every 24 hours until released from the hospital. It should take about 10 minutes to complete the questions each time. The survey will not interfere with the care the healthcare team will be providing. Patients will be asked to fill our a Patient Satisfaction Questionnaire at the time of discharge.
ACTIVE_COMPARATOR: Arm B: APN Intervention Group; Patients randomized to this group will be asked to fill out a patient symptom assessment using an iPad at the time of registration and then every day until released from the hospital. It should take about 10 minutes to complete this questionnaire each time. Based on the patients' answers and in cooperation with their health care provider, an Advanced Practice Nurse (APN) will provide information about symptom management and options for services that are available after the patient leaves the hospital. The survey responses will be shared with the patients' healthcare team so that they better understand how they are feeling. The APN will work closely with the healthcare team. Patients will be asked to fill out a Patient Satisfaction Questionnaire at the time of discharge.	Other: APN Intervention; Patients randomized to this group will be asked to fill out a patient symptom assessment using an iPad at the time of registration and then every day until released from the hospital. It should take about 10 minutes to complete this questionnaire each time. Based on the patients' answers and in cooperation with their health care provider, an Advanced Practice Nurse (APN) will provide information about symptom management and options for services that are available after the patient leaves the hospital. The survey responses will be shared with the patients' healthcare team so that they better understand how they are feeling. The APN will work closely with the healthcare team. Patients will be asked to fill out a Patient Satisfaction Questionnaire at the time of discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.	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.	3 years
Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.	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.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Assess level of understanding about advance care planning in both the control and intervention group.	3 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Emily Berry, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: April 14, 2013
• First Posted (ESTIMATE): April 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Women; Palliative Care; Advanced Care Planning
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: STU00064629