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Evaluation of a Symptom and Needs Assessment for Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04014751
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Information provided by (Responsible Party):
Sofia Garcia, Northwestern University

Brief Summary:
This is a quality improvement study that aims to improve on the timely identification and management of symptoms and supportive care needs in patients with cancer. The study will be evaluating the relative success of an existing on-line patient-reported symptom and needs assessment, and then the implementation and use of an updated version of the symptom and needs assessment with Northwestern Medicine (NM) cancer patients. It also aims to evaluate the impact of the symptom and needs assessment system on healthcare delivery and quality of care. Participants who complete the symptom and needs assessment as part of their usual care are invited to participate in the study by agreeing to complete an on-line survey (at 3 different time points) that asks about quality of life, adverse symptoms related to cancer and cancer treatment, patient experiences with their cancer care team, and the healthcare services they have received. Patients may also be invited to participate in a one-time interview or focus group about patient experiences with the symptom and needs assessment.

Condition or disease Intervention/treatment
Cancer Other: Symptom Monitoring Intervention

Detailed Description:

Cancer patients' under-identified symptoms and concerns can result in treatment interference, poor care satisfaction, compromised health-related quality of life, and taxed healthcare systems. Cancer care organizations have emphasized the need for symptom assessment and management within quality cancer care delivery. We have leveraged health information technology to pilot and implement the Lurie Screening Initiative in the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) within the Central region of Northwestern Medicine (NM). Following two pilot implementation projects, the screening initiative program is live in RHLCCC clinics. It allows patients to complete Patient Reported Outcomes Measurement Information System computer adaptive tests (PROMIS CATs) assessing depression, anxiety, fatigue, pain, and physical function, along with checklists of supportive care needs, within the electronic health record (EHR). Patients can do so at home via MyChart (a patient portal of their EHR) or in clinic via an EHR hyperlink. Assessment results immediately populate the EHR; severe symptoms and endorsed supportive care needs trigger notifications to clinicians (social workers, dieticians, oncologists & oncology nurses) who can then make referrals and care decisions in real time.

This study will expand and evaluate implementation of the screening initiative via these aims:

Aim 1. Evaluate the impact of system-wide implementation of the program on patient and system outcomes over 12 months via (a) a quality improvement study (estimated n=4,000 cases) to compare the impact of the program (versus usual care) on EHR-documented health care usage and patient satisfaction using a stepped wedge design in which clusters of study sites will gradually be assigned to cross from serving as a control to implementing the program and (b) a human subjects substudy (n=1,000) with patients who will complete the symptom monitoring and other patient-reported outcomes (PRO) measures of health care usage and satisfaction at baseline, 6 & 12 months. We will examine differences in PROs between participants whose screening responses trigger clinical alerts and those who do not. We will also explore longitudinal trajectories of PRO scores

Aim 3. Identify implementation facilitators and barriers to system-wide expansion of the program. We will conduct qualitative research to gather feedback from patients participating in the program expansion (n=50). This will include multiple assessments throughout implementation.

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Study Type : Observational
Estimated Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Expansion, Implementation & Evaluation of Electronic Health Record (EHR)-Integrated Patient-Reported Symptom Screening in a Multi-Site Cancer Center
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Symptom Monitoring Cohort
This cohort will include up to1,050 cancer patients being seen at regional Northwestern Medicine (NM) cancer centers for their cancer care. Patients who have recently completed an on-line, EHR-integrated patient-reported symptom and needs assessment as part of their regular care will be invited to complete a survey at baseline, 6- and 12-months targeting the assessment of their symptoms, healthcare experiences and utilization. Patients may also be invited to participate in a one-time interview or focus group designed to help study investigators better understand the value of the symptom and needs assessment from the patient perspective.
Other: Symptom Monitoring Intervention
This study involves a cancer care delivery process improvement component where all cohort participants, at specified timepoints, are assessed for psychological distress, pain, fatigue, physical function, practical and supportive needs, and dietary and nutritional needs. Patients with severe elevations in psychological distress, physical symptoms or those who endorse supportive care and/or dietary needs are triaged in real time to appropriate providers within the health system (i.e., social work, nursing pool, nutrition services) to address elevated scores and/or stated needs. As such, within the context of this process improvement care delivery project, real time referrals function as interventional processes within the health system to route patients to relevant points of care based on their needs.

Primary Outcome Measures :
  1. Effects of the symptom monitoring system on patient-reported quality of life related to cancer and cancer treatment [ Time Frame: Change from baseline quality of life at 12-months ]
    Quality of life will be assessed using a brief, validated 7-item patient-reported questionnaire (Functional Assessment of Cancer Therapy-General 7-item or FACT-G7) that asks about symptoms of fatigue, pain, and nausea, sleep quality and contentment with life.

  2. Effects of the symptom monitoring system on severity of patient-reported symptoms related to cancer and cancer treatment [ Time Frame: Change from baseline symptom severity at 12-months ]
    Symptom severity will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT) that will ask about depression, anxiety, pain, fatigue, and physical functioning. CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Patient usually completes 4-12 items with a high level of measurement.

  3. Effects of the symptom monitoring system on patient-reported adverse events related to cancer and cancer treatment [ Time Frame: Change from baseline adverse events at 12-months ]
    Adverse events will be assessed using the Patient-Reported Outcomes- Common Terminology Criteria for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask questions about nausea, constipation, insomnia, vomiting, shortness of breath, and diarrhea.

  4. Impact of the symptom monitoring system on health care services used by patients [ Time Frame: Change from baseline use of healthcare services at 12 months ]
    Utilization of services related to physical and mental health will be measured using a patient-reported questionnaire to assess healthcare services used by participants, such as number of emergency room visits, oncology urgent care visits, general urgent care visits, doctor visits, referrals for services within and outside the health system, and overnight stays in the hospital.

Secondary Outcome Measures :
  1. Impact of the symptom monitoring system on patient experiences with their cancer care team [ Time Frame: Change from baseline patient experiences with their cancer care team at 12 months ]
    Patient experiences with their cancer care team will be measured using components of a standardized measure (Consumer Assessment of Healthcare Providers and Systems or CAHPS) designed to assess patient experiences with their healthcare provider and system.

  2. Patient experiences (barriers and facilitators) using the symptom and needs assessment [ Time Frame: Patient experiences will be assessed at one time point between baseline and 12 months ]
    Patient experiences with the symptom and needs assessment will be evaluated using qualitative methods (semi-structured interview or focus group)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes patients at Northwestern Medicine (NM) who have a confirmed diagnosis of a solid or hematological malignancy and have had oncology services at NM within the past 12-months.
  1. Must have medical chart confirmed diagnosis of a solid or hematological malignancy
  2. Must have had oncology services at a Northwestern Medicine location within the past 12 months
  3. Must have completed the current symptom monitoring assessment offered by Northwestern Medicine
  4. Must be willing to complete electronic patient-reported measures (i.e. patient reported health care utilization and satisfaction surveys) at baseline, 6-month, and 12-month follow-up time points, and
  5. Must consent to give authorized study staff access to details of their cancer diagnosis and treatment as documented in their electronic health record
  6. If participating in a semi-structured interview or focus group, must consent to have their comments audio-recorded

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04014751

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Contact: Madison Lyleroehr, MA 312-503-3486
Contact: Kimberly Webster, MA 312-503-3421

Sponsors and Collaborators
Northwestern University
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Principal Investigator: Sofia Garcia, PHD Northwestern University Feinberg School of Medicine

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Responsible Party: Sofia Garcia, Research Associate Professor, Northwestern University Identifier: NCT04014751     History of Changes
Other Study ID Numbers: 1R18HS026170-01 ( U.S. AHRQ Grant/Contract )
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sofia Garcia, Northwestern University: