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Electronic Patient Reported Symptom Assessment

Primary Purpose

Gynecologic Cancer, Breast Cancer, Thoracic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APN Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring Advanced Care Planning, Palliative Care, Women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm A: Control Group

Arm B: APN Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2012
Last Updated
July 13, 2015
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01833637
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Breast Cancer, Thoracic Cancer, Gastrointestinal Cancer
Keywords
Advanced Care Planning, Palliative Care, Women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Arm B: APN Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
APN Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identify perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.
Description
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.
Time Frame
3 years
Title
Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Examine scores of electronic reported symptom assessment combined with targeted intervention to see it it improves symptoms scores over the course of hospitalization.
Time Frame
3 years
Title
Use electronic symptom scoring, targeted intervention, and sequential assessments every 24 hours to assess the impact on length of hospitalization and readmissions.
Time Frame
3 years
Title
Assess level of understanding about advance care planning in both the control and intervention group.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Berry, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Electronic Patient Reported Symptom Assessment

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