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Completed

NCT Number: NCT01833637

Electronic Patient Reported Symptom Assessment

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.

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Key information

Conditions

Gynecologic Cancer Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Thoracic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

APN intervention

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Assess level of understanding about advance care planning in both the control and intervention group.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2013
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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