CancerNCT04014751
Evaluation of a Symptom and Needs Assessment for Patients With Cancer
An observational study of Cancer, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Symptom Monitoring Intervention
- How many people
- 1,166 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expansion, Implementation & Evaluation of Electronic Health Record (EHR)-Integrated Patient-Reported Symptom Screening in a Multi-Site Cancer Center
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Symptom Monitoring Intervention
- Keywords
- Symptom-monitoring
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Monitoring InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Symptom Monitoring Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the symptom monitoring system on patient-reported quality of life related to cancer and cancer treatment
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.
Measured: Change from baseline quality of life at 12-months
Effects of the symptom monitoring system on severity of patient-reported symptoms related to cancer and cancer treatment
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.
Measured: Change from baseline symptom severity at 12-months
Effects of the symptom monitoring system on patient-reported adverse events related to cancer and cancer treatment
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, and diarrhea.
Measured: Change from baseline adverse events at 12-months
Impact of the symptom monitoring system on health care services used by patients
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.
Measured: Change from baseline use of healthcare services at 12 months
Secondary outcomes (2)
Impact of the symptom monitoring system on patient experiences with their cancer care team
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.
Measured: Change from baseline patient experiences with their cancer care team at 12 months
Patient experiences (barriers and facilitators) using the symptom and needs assessment
Patient experiences with the symptom and needs assessment will be evaluated using qualitative methods (semi-structured interview or focus group)
Measured: Patient experiences will be assessed at one time point between baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Sofia Garcia, Northwestern University
- Investigators
- Sofia Garcia, PHD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014751
- Sponsor's protocol ID
- 1R18HS026170-01
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith JD, Merle JL, Webster KA, Cahue S, Penedo FJ, Garcia SF. Tracking dynamic changes in implementation strategies over time within a hybrid type 2 trial of an electronic patient-reported oncology symptom and needs monitoring program. Front Health Serv. 2022 Nov 1;2:983217. doi: 10.3389/frhs.2022.983217. eCollection 2022.
PubMed 36925901Garcia SF, Smith JD, Kallen M, Webster KA, Lyleroehr M, Kircher S, Bass M, Cella D, Penedo FJ. Protocol for a type 2 hybrid effectiveness-implementation study expanding, implementing and evaluating electronic health record-integrated patient-reported symptom monitoring in a multisite cancer centre. BMJ Open. 2022 May 3;12(5):e059563. doi: 10.1136/bmjopen-2021-059563.
PubMed 35504641
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion, Implementation & Evaluation of Electronic Health Record (EHR)-Integrated Patient-Reported Symptom Screening in a Multi-Site Cancer Center
- ClinicalTrials.gov ID
- NCT04014751
- Acronym / sponsor ID
- 1R18HS026170-01
- Conditions
- Cancer
- Keywords
- Symptom-monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom Monitoring Cohort | – | Other: Symptom Monitoring InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom Monitoring InterventionThis 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. | Other | Symptom Monitoring Cohort |
Primary outcome
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.
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.
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, and diarrhea.
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.
2 secondary outcomes
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 (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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 36925901Smith JD, Merle JL, Webster KA, Cahue S, Penedo FJ, Garcia SF. Tracking dynamic changes in implementation strategies over time within a hybrid type 2 trial of an electronic patient-reported oncology symptom and needs monitoring program. Front Health Serv. 2022 Nov 1;2:983217. doi: 10.3389/frhs.2022.983217. eCollection 2022.
- Derived from this study: PubMed 35504641Garcia SF, Smith JD, Kallen M, Webster KA, Lyleroehr M, Kircher S, Bass M, Cella D, Penedo FJ. Protocol for a type 2 hybrid effectiveness-implementation study expanding, implementing and evaluating electronic health record-integrated patient-reported symptom monitoring in a multisite cancer centre. BMJ Open. 2022 May 3;12(5):e059563. doi: 10.1136/bmjopen-2021-059563.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Garcia, PHD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.