CancerNU IMPACTNCT03988543
Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center
A study testing Patient Self-management in people with Cancer, run by Northwestern University at 1 site in United States.
Trial summary
Cancer, and cancer treatment, cause many symptoms that can negatively affect quality of life. Despite the development of improved symptom management interventions and several evidence- and consensus-based guidelines, their timely delivery remains uneven in the health care system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient Self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,104 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 15 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- Curative Intent Group:
- ≥ 18 years of age;
- medical chart confirmed diagnosis of a solid or hematological malignancy;
- willingness to be randomized (post-implementation only);
- have initiated primary treatment with curative intent within the past 3 months (i.e., as patients receive surgery, standard- or high-dose chemotherapy, biological therapy, and/or radiotherapy);
- provider confirmed planned treatment and follow-up within the Northwestern Medicine HealthCare (NMHC) hospital and clinics;
Show all 24Show fewer
- able to read English or Spanish; and
- no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.
- Non-Curative/Palliative Intent Group:
- ≥ 18 years of age;
- medical chart confirmed diagnosis of advanced or metastatic solid or hematological malignancy;
- willingness to be randomized (post-implementation only);
- undergoing cancer treatment with non-curative/palliative intent (e.g., patients with advanced or metastatic disease who receive chemotherapy, biological therapy, and/or radiotherapy to control or slow advance of their disease);
- provider confirmed planned treatment and follow-up within the NMHC hospital and clinics;
- able to read English or Spanish; and
- no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.
- Cancer Survivorship Group:
- ≥ 18 years of age;
- medical chart confirmed diagnosis of solid or hematological malignancy within the past 2 years;
- willingness to be randomized (post-implementation only);
- completed active cancer treatment with curative intent, including those who may be receiving maintenance or prophylactic cancer treatment;
- provider confirmed planned follow-up (with or without treatment) within the NMHC e hospital and clinics;
- able to read English or Spanish; and
- no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program Across a Multi-site, Fully-integrated Comprehensive Cancer Center
Cancer, and cancer treatment, cause many symptoms that can negatively affect quality of life. Despite the development of improved symptom management interventions and several evidence- and consensus-based guidelines, their timely delivery remains uneven in the health care system. Our research center, Northwestern University IMPACT (NU IMPACT), builds upon an electronic health record (EHR)-integrated cancer symptom monitoring and management system, currently deployed by our health care system. We are testing the effectiveness of a system-wide symptom management intervention and the EHR-integrated enhanced care approach, which offers a more personalized symptom monitoring and management experience based on a person's unique needs and language (i.e., English or Spanish).
Read the detailed description
Using a clinic-level randomized roll-out implementation trial design, we will test the effectiveness of an enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. The existing EHR-integrated symptom monitoring system will constitute usual care (UC), and added patient engagement and activation features will comprise the EC condition.
Project aims target both patient- and system-level outcomes. Aim 1: Implement a fully-integrated oncology symptom assessment and management program across six clinical units that are part of the NMHC healthcare delivery system; Aim 2: Evaluate the impact of the program by conducting a hybrid Type I effectiveness-implementation trial to evaluate the enhanced care program (EC: symptom monitoring \& self-management intervention), relative to usual care (UC) on patient- and system-level outcomes; Aim 3: Identify facilitators and barriers to implementation and disseminate to other health systems. We will enroll an estimated 12,671 participants. To address possible contamination effects within each clinical unit, and allow for unit-level data collection for pre- and post-implementation comparison within and across clinical units, 50% will be enrolled and followed prior to program implementation. The other half will be enrolled post-implementation and will be randomly assigned at a 1:1 ratio (stratified by sex and cancer phase; curative intent, non-curative intent \& survivorship) to UC versus EC. Fatigue, pain, anxiety, and depression will be assessed using Patient Reported Outcome Measurement Information System (PROMIS®) computerized adaptive tests (CATs). In addition, we will assess patient clinical outcomes, including healthcare utilization, and cancer treatment delivery outcomes.
- Conditions
- Cancer
- Being tested
- Patient Self-management
- Keywords
- Curative Intent, Non-curative Intent, Survivorship Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Self-managementBehavioural
Also called Patient Engagement
Enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. After patients complete the current EHR-integrated symptom monitoring, they will receive web-based, patient-centered information to gain knowledge on cancer-related outcomes, improve self-management skills, improve communication skills, and empower them to improve motivation and self-management.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will receive current standard care of EHR-integrated symptom monitoring. |
| Enhanced Care | Experimental | Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention. Receives: Behavioral: Patient Self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual-level change overtime related to cancer and cancer treatment symptoms
Symptom severity will be assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) related to symptoms of pain, fatigue, depression, anxiety, and physical function. CAT question 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 precision for each domain.
Measured: Change from baseline adverse symptom severity at 12 months
Adverse symptom severity related to cancer and cancer treatment
Adverse symptom severity will be assessed using Patient-Reported Outcomes- Common Terminology for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask about nausea, constipation, insomnia, vomiting, shortness of breath, and diarrhea.
Measured: Change from baseline PRO-CTCAE adverse event severity at 12 month
Healthcare utilization by participant related to managing their cancer and cancer treatment
Participant utilization of healthcare services, such as number of emergency room visits, oncology urgent care visits, unscheduled doctor visits, doctor visits, hospital admissions and length of stay, and supportive care needs to manage their cancer and cancer treatment, will be assessed by electronic health records.
Measured: Change from baseline healthcare utilization at 12 months
Patient Treatment Delivery Satisfaction
Patient satisfaction of their cancer-related care will be assessed using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey composite measures.
Measured: Change from baseline treatment delivery satisfaction at 12 months
Secondary outcomes (4)
Patient clinical outcome of cancer recurrence (i.e., cancer has come back)
Cancer recurrence will be assessed by electronic health record diagnosis codes in patients in curative intent and survivorship groups.
Measured: Cancer recurrance at 12 months
Patient clinical outcome of cancer progression (i.e., cancer has becomes worse)
Cancer progression will be assessed by electronic health records diagnosis codes in curative intent and non-curative intent groups.
Measured: Cancer progression at 12 months
Patient clinical outcome of second cancer (i.e., completely new and a different type of cancer than the first one)
Second cancer will be assessed by patient medical record diagnosis codes in curative intent, non-curative intent, and survivorship groups.
Measured: Second cancer at 12 months
Overall Survival (i.e., the time from study randomization until death due to any cause)
Overall survival will be assessed by electronic health records in the curative intent and non-curative intent groups.
Measured: Overall survival at 12 months (or end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start28 Sep 2020
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial design, in conjunction with our aims and measurement strategy, is consistent with a hybrid Type I effectiveness-implementation trial, which primarily tests the clinical effectiveness of an evidence-based intervention while secondarily documenting and evaluating its implementation. The randomized roll-out implementation trial design is in the same class as the commonly-used stepped wedge trial, but is more practical for real-world application due to lower measurement burden on clinics due to using incomplete wedges. To assess implementation at the level of the clinic, and control for patient-level outcome prior to implementation, we use a pragmatic randomized roll-out implementation trial design with an embedded patient-level randomized group-based comparison.
- Masking
- None (open label)
- Enrolment
- 4,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Medicine, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Cella, Northwestern University
- Investigators
- David Cella, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988543
- Sponsor's protocol ID
- 1UM1CA233035-01
- Other IDs
- 1UM1CA233035-01
- Acronym
- NU IMPACT
- Status last verified
- Nov 2024
- First submitted
- 8 May 2019
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nolla KM, Kuharic M, Lancki N, Walsh-Bailey CL, Flores AM, Garcia SF, Jensen RE, Wang Y, Mai Q, Mercer AM, Smith JD, Psihogios AM, Webster KA, Kircher SM, Franklin PD, Cella D, Yanez BR. Patient Portal Engagement in Oncology: Results From the NU IMPACT Study in a Large Health Care System. JCO Clin Cancer Inform. 2025 Dec;9:e2500178. doi: 10.1200/CCI-25-00178. Epub 2025 Dec 10.
PubMed 41370780Smith JD, Bedjeti K, Lancki N, Sloss EA, Merle JL, Kircher S, Coughlin A, Metzger S, Webster KA, O'Connor M, Cahue S, Flores AM, Mai Q, Yanez B, Bass M, Jensen RE, Smith AW, Carroll AJ, Barnard C, George CM, Tsarwhas DG, Richardson K, Penedo FJ, Hemming K, Garcia SF, Scholtens DM, Cella D. Implementation outcomes of a symptom management intervention in ambulatory oncology practices evaluated using a cluster randomized stepped-wedge trial design. Implement Sci. 2025 Dec 2;21(1):10. doi: 10.1186/s13012-025-01475-y.
PubMed 41331816Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.
PubMed 40524282Cella D, Lancki N, Kuharic M, Yanez B, Bass M, Garcia MG, Webster KA, Smith JD, O'Connor M, Coughlin A, Cahue S, Kircher S, Flores AM, Penedo FJ, Jensen RE, Wilder Smith A, Richardson K, Barnard C, George CM, Tsarwhas DG, Scholtens D, Garcia SF. Web-Based Cancer Symptom Self-Management System: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258353. doi: 10.1001/jamanetworkopen.2025.8353.
PubMed 40323601Scholtens DM, Lancki N, Hemming K, Cella D, Smith JD. Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial. Contemp Clin Trials. 2024 Aug;143:107603. doi: 10.1016/j.cct.2024.107603. Epub 2024 Jun 8.
PubMed 38852769Cella D, Garcia SF, Cahue S, Smith JD, Yanez B, Scholtens D, Lancki N, Bass M, Kircher S, Flores AM, Jensen RE, Smith AW, Penedo FJ. Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol. Contemp Clin Trials. 2023 May;128:107171. doi: 10.1016/j.cct.2023.107171. Epub 2023 Mar 28.
PubMed 36990275
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program Across a Multi-site, Fully-integrated Comprehensive Cancer Center
- ClinicalTrials.gov ID
- NCT03988543
- Acronym / sponsor ID
- NU IMPACT / 1UM1CA233035-01
- Conditions
- Cancer
- Keywords
- Curative Intent, Non-curative Intent, Survivorship Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,104 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Medicine, National Cancer Institute (NCI)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 17 Jun 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.
Cancer, and cancer treatment, cause many symptoms that can negatively affect quality of life. Despite the development of improved symptom management interventions and several evidence- and consensus-based guidelines, their timely delivery remains uneven in the health care system. Our research center, Northwestern University IMPACT (NU IMPACT), builds upon an electronic health record (EHR)-integrated cancer symptom monitoring and management system, currently deployed by our health care system. We are testing the effectiveness of a system-wide symptom management intervention and the EHR-integrated enhanced care approach, which offers a more personalized symptom monitoring and management experience based on a person's unique needs and language (i.e., English or Spanish).
Detailed description
Using a clinic-level randomized roll-out implementation trial design, we will test the effectiveness of an enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. The existing EHR-integrated symptom monitoring system will constitute usual care (UC), and added patient engagement and activation features will comprise the EC condition.
Project aims target both patient- and system-level outcomes. Aim 1: Implement a fully-integrated oncology symptom assessment and management program across six clinical units that are part of the NMHC healthcare delivery system; Aim 2: Evaluate the impact of the program by conducting a hybrid Type I effectiveness-implementation trial to evaluate the enhanced care program (EC: symptom monitoring \& self-management intervention), relative to usual care (UC) on patient- and system-level outcomes; Aim 3: Identify facilitators and barriers to implementation and disseminate to other health systems. We will enroll an estimated 12,671 participants. To address possible contamination effects within each clinical unit, and allow for unit-level data collection for pre- and post-implementation comparison within and across clinical units, 50% will be enrolled and followed prior to program implementation. The other half will be enrolled post-implementation and will be randomly assigned at a 1:1 ratio (stratified by sex and cancer phase; curative intent, non-curative intent \& survivorship) to UC versus EC. Fatigue, pain, anxiety, and depression will be assessed using Patient Reported Outcome Measurement Information System (PROMIS®) computerized adaptive tests (CATs). In addition, we will assess patient clinical outcomes, including healthcare utilization, and cancer treatment delivery outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial design, in conjunction with our aims and measurement strategy, is consistent with a hybrid Type I effectiveness-implementation trial, which primarily tests the clinical effectiveness of an evidence-based intervention while secondarily documenting and evaluating its implementation. The randomized roll-out implementation trial design is in the same class as the commonly-used stepped wedge trial, but is more practical for real-world application due to lower measurement burden on clinics due to using incomplete wedges. To assess implementation at the level of the clinic, and control for patient-level outcome prior to implementation, we use a pragmatic randomized roll-out implementation trial design with an embedded patient-level randomized group-based comparison.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive current standard care of EHR-integrated symptom monitoring. |
| Enhanced Care | Experimental | Behavioral: Patient Self-managementPatient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- ≥ 18 years of age;
- medical chart confirmed diagnosis of a solid or hematological malignancy;
- willingness to be randomized (post-implementation only);
- have initiated primary treatment with curative intent within the past 3 months (i.e., as patients receive surgery, standard- or high-dose chemotherapy, biological therapy, and/or radiotherapy);
- provider confirmed planned treatment and follow-up within the Northwestern Medicine HealthCare (NMHC) hospital and clinics;
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 |
|---|---|---|
| Patient Self-managementAlso: Patient EngagementEnhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. After patients complete the current EHR-integrated symptom monitoring, they will receive web-based, patient-centered information to gain knowledge on cancer-related outcomes, improve self-management skills, improve communication skills, and empower them to improve motivation and self-management. | Behavioural | Enhanced Care |
Primary outcome
Individual-level change overtime related to cancer and cancer treatment symptoms
Time frame: Change from baseline adverse symptom severity at 12 months
Symptom severity will be assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) related to symptoms of pain, fatigue, depression, anxiety, and physical function. CAT question 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 precision for each domain.
Adverse symptom severity related to cancer and cancer treatment
Time frame: Change from baseline PRO-CTCAE adverse event severity at 12 month
Adverse symptom severity will be assessed using Patient-Reported Outcomes- Common Terminology for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask about nausea, constipation, insomnia, vomiting, shortness of breath, and diarrhea.
Healthcare utilization by participant related to managing their cancer and cancer treatment
Time frame: Change from baseline healthcare utilization at 12 months
Participant utilization of healthcare services, such as number of emergency room visits, oncology urgent care visits, unscheduled doctor visits, doctor visits, hospital admissions and length of stay, and supportive care needs to manage their cancer and cancer treatment, will be assessed by electronic health records.
Patient Treatment Delivery Satisfaction
Time frame: Change from baseline treatment delivery satisfaction at 12 months
Patient satisfaction of their cancer-related care will be assessed using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey composite measures.
4 secondary outcomes
Patient clinical outcome of cancer recurrence (i.e., cancer has come back)
Time frame: Cancer recurrance at 12 months
Patient clinical outcome of cancer progression (i.e., cancer has becomes worse)
Time frame: Cancer progression at 12 months
Patient clinical outcome of second cancer (i.e., completely new and a different type of cancer than the first one)
Time frame: Second cancer at 12 months
Overall Survival (i.e., the time from study randomization until death due to any cause)
Time frame: Overall survival at 12 months (or end of study)
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 27 Nov 2024.
- Derived from this study: PubMed 41370780Nolla KM, Kuharic M, Lancki N, Walsh-Bailey CL, Flores AM, Garcia SF, Jensen RE, Wang Y, Mai Q, Mercer AM, Smith JD, Psihogios AM, Webster KA, Kircher SM, Franklin PD, Cella D, Yanez BR. Patient Portal Engagement in Oncology: Results From the NU IMPACT Study in a Large Health Care System. JCO Clin Cancer Inform. 2025 Dec;9:e2500178. doi: 10.1200/CCI-25-00178. Epub 2025 Dec 10.
- Derived from this study: PubMed 41331816Smith JD, Bedjeti K, Lancki N, Sloss EA, Merle JL, Kircher S, Coughlin A, Metzger S, Webster KA, O'Connor M, Cahue S, Flores AM, Mai Q, Yanez B, Bass M, Jensen RE, Smith AW, Carroll AJ, Barnard C, George CM, Tsarwhas DG, Richardson K, Penedo FJ, Hemming K, Garcia SF, Scholtens DM, Cella D. Implementation outcomes of a symptom management intervention in ambulatory oncology practices evaluated using a cluster randomized stepped-wedge trial design. Implement Sci. 2025 Dec 2;21(1):10. doi: 10.1186/s13012-025-01475-y.
- Derived from this study: PubMed 40524282Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.
- Derived from this study: PubMed 40323601Cella D, Lancki N, Kuharic M, Yanez B, Bass M, Garcia MG, Webster KA, Smith JD, O'Connor M, Coughlin A, Cahue S, Kircher S, Flores AM, Penedo FJ, Jensen RE, Wilder Smith A, Richardson K, Barnard C, George CM, Tsarwhas DG, Scholtens D, Garcia SF. Web-Based Cancer Symptom Self-Management System: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258353. doi: 10.1001/jamanetworkopen.2025.8353.
- Derived from this study: PubMed 38852769Scholtens DM, Lancki N, Hemming K, Cella D, Smith JD. Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial. Contemp Clin Trials. 2024 Aug;143:107603. doi: 10.1016/j.cct.2024.107603. Epub 2024 Jun 8.
- Derived from this study: PubMed 36990275Cella D, Garcia SF, Cahue S, Smith JD, Yanez B, Scholtens D, Lancki N, Bass M, Kircher S, Flores AM, Jensen RE, Smith AW, Penedo FJ. Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol. Contemp Clin Trials. 2023 May;128:107171. doi: 10.1016/j.cct.2023.107171. Epub 2023 Mar 28.
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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.
David Cella, 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?
A study testing Patient Self-management in people with 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 24 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 27 Nov 2024. 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?
Individual-level change overtime related to cancer and cancer treatment symptoms (time frame: Change from baseline adverse symptom severity 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 NCT03988543, which also lists 6 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 27 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.