Electronic Patient Reported Symptom Assessment

NCT ID: NCT01833637

Last Updated: 2015-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-06-30

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.

Conditions

Gynecologic Cancer; Breast Cancer; Thoracic Cancer; Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

APN Intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Emily Berry

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Berry, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00064629

Identifier Type: -

Identifier Source: org_study_id