Hematopoietic and Lymphoid Cell NeoplasmNCT03892967

Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

A study testing Interview, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
What is being tested?: Interview, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50,207 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2019to 31 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester

Who cannot join

No Minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial

This early phase I trial investigates enhanced, electronic health record (EHR)-facilitated cancer system control. Cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. Collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (SPADE symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.

Read the detailed description

PRIMARY OBJECTIVES:

Conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life.

II. Evaluate the hypothesis that use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 system will result in improvements in implementation and clinical outcomes.

III. Conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.

OUTLINE:

The first Primary Objective involves a stepped wedge enrollment into the study intervention. Involvement is based off the patients' responses to the pain questionnaire (low pain = no involvement, moderate pain = offer of patient education materials, severe pain = involvement of a Symptom Care Manager). Symptom Care Managers will work with interested patients who endorse high pain to help address and manage their pain. The third objective involves a subset of patients included in the E2C2 who are offered to participate in a one-time interview lasting 30-45 minutes. Providers and stakeholders also will be invited to participate in an interview lasting 15-30 minutes.

Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Being tested: Interview, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InterviewOther
Participate in interview
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT03892967
Study group	Role	What they receive
Supportive care (interview)	Experimental	Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes. Receives: Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes.
Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.
Measured: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Physical Function Numerical Rating Scale (NRS) Scores
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes.
Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of >=4/10 modeled jointly as a co-primary outcome.
Measured: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)

Secondary outcomes (7)

Change in Anxiety Score
Measured PROMIS-CAT T-scores up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Measured: Baseline to 46 months
Change in Depression Score
Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Measured: Baseline to 46 months
Change in Average Pain Interference Over the Past Week
Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Measured: Baseline to 46 months
Change in Physical Function Score
Measured PROMIS-CAT up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a better outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Measured: Baseline to 46 months
Health Care Utilization
ER visits, hospitalizations, and ICU admissions
Measured: Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)
Adherence to Cancer Treatment
Number of doses of docetaxel and cyclophosphamide administered.
Measured: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)
Number of Deceased Participants
Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index
Measured: Up to 46 months (beginning from a participants' index medical oncology encounter until death 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.

28 Mar 201931 Jan 2023

First posted27 Mar 2019
Study start28 Mar 2019
Primary completion31 Jan 2023
Study completion31 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50,207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03892967
Sponsor's protocol ID: 18-007779
Other IDs: NCI-2020-06973, P30CA015083, UM1CA233033, E2C2
Status last verified: May 2025
First submitted: 19 Mar 2019
Last updated: 7 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Finney Rutten LJ, Ruddy KJ, Chlan LL, Griffin JM, Herrin J, Leppin AL, Pachman DR, Ridgeway JL, Rahman PA, Storlie CB, Wilson PM, Cheville AL. Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2). Trials. 2020 Jun 5;21(1):480. doi: 10.1186/s13063-020-04335-w.
PubMed 32503661
Cheville AL, Herrin J, Pachman DR, Grzegorczyk V, Kroenke K, Ridgeway JL, Minteer SA, Austin JD, Griffin JM, Chlan L, Tofthagen C, Mitchell SA, Smith A, Ruddy KJ. Electronic health record-facilitated symptom surveillance and collaborative care intervention in oncology (E2C2): a cluster-randomised, population-level, stepped-wedge, pragmatic trial. Lancet Oncol. 2026 Jan;27(1):125-136. doi: 10.1016/S1470-2045(25)00526-1. Epub 2025 Dec 1.
PubMed 41344348
Minteer SA, Ridgeway JL, Pachman DR, Austin JD, Griffin JM, Ruddy KJ, Cheville AL. Barriers and facilitators to using practice facilitators to implement a remote cancer symptom management intervention: a mixed methods study. BMC Health Serv Res. 2025 Sep 3;25(1):1189. doi: 10.1186/s12913-025-13378-1.
PubMed 40903741
Kuharic 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 40524282
Austin JD, Finney Rutten LJ, Fischer K, Ridgeway J, Minteer S, Griffin JM, Pachman DR, Ruddy KJ, Cheville A. Advancing Care Team Adoption of Electronic Health Record Systems for Cancer Symptom Management: Findings From a Hybrid Type II, Cluster-Randomized, Stepped-Wedge Trial. JCO Oncol Pract. 2025 Feb;21(2):209-217. doi: 10.1200/OP.24.00280. Epub 2024 Aug 6.
PubMed 39106420
Ridgeway JL, Cheville AL, Fischer KJ, Tesch NK, Austin JD, Minteer SA, Pachman DR, Chlan LL, Ruddy KJ, Griffin JM. Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention. Contemp Clin Trials Commun. 2024 Feb 9;38:101269. doi: 10.1016/j.conctc.2024.101269. eCollection 2024 Apr.
PubMed 38380342
Kroenke K, Lam V, Ruddy KJ, Pachman DR, Herrin J, Rahman PA, Griffin JM, Cheville AL. Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer. J Pain Symptom Manage. 2023 May;65(5):367-377. doi: 10.1016/j.jpainsymman.2023.01.020. Epub 2023 Feb 2.
PubMed 36738867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hematopoietic and Lymphoid Cell Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial
ClinicalTrials.gov ID: NCT03892967
Acronym / sponsor ID: 18-007779
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Study type: Interventional
Recruitment status: Completed
Enrolment: 50,207 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 28 Mar 2019 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 27 Mar 2019 (actual)
Results: Posted 7 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life.

III. Conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.

OUTLINE:

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Supportive care (interview)	Experimental	Other: Interview, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester

Key exclusion criteria (1 listed)

No Minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment

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
InterviewParticipate in interview	Other	Supportive care (interview)
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Supportive care (interview)
Questionnaire AdministrationAncillary studies	Other	Supportive care (interview)

Primary outcome

Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.
Physical Function Numerical Rating Scale (NRS) Scores
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of >=4/10 modeled jointly as a co-primary outcome.

7 secondary outcomes

Change in Anxiety Score
Time frame: Baseline to 46 months
Change in Depression Score
Time frame: Baseline to 46 months
Change in Average Pain Interference Over the Past Week
Time frame: Baseline to 46 months
Change in Physical Function Score
Time frame: Baseline to 46 months
Health Care Utilization
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)
Adherence to Cancer Treatment
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)
Number of Deceased Participants
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)

Results and safety

Results posted to the registry on 7 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	2,709	1,426
Sequence 2	4,023	2,295
Sequence 3	4,353	2,530
Sequence 4	3,724	2,281
Sequence 5	1,906	1,178

Primary outcome: Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.

Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study). Mean (95% Confidence Interval). Unit: score on a scale

Measure	Usual Care (Control) n = 16180	EHR-facilitated Collaborative Care (Intervention) n = 19084
Anxiety	2.09 (2.05 to 2.13)	1.98 (1.94 to 2.02)
Depression	1.90 (1.86 to 1.93)	1.81 (1.78 to 1.85)
Fatigue	3.27 (3.22 to 3.32)	3.21 (3.15 to 3.26)
Pain	2.18 (2.12 to 2.24)	2.14 (2.09 to 2.20)
Impaired Physical Function	2.75 (2.69 to 2.80)	2.78 (2.72 to 2.84)
Sleep	2.46 (2.41 to 2.51)	2.39 (2.34 to 2.44)

Population analysed: The analytic cohort includes trial participants who completed 2 or more NRS assessments.

Primary outcome: Physical Function Numerical Rating Scale (NRS) Scores

Measure	Usual Care (Control) n = 9839	EHR-facilitated Collaborative Care (Intervention) n = 13084
Anxiety	2.51 (2.05 to 2.63)	2.37 (2.24 to 2.49)
Depression	2.27 (2.14 to 2.40)	2.17 (2.04 to 2.30)
Fatigue	3.96 (3.80 to 4.12)	3.87 (3.72 to 4.03)
Pain	2.53 (2.37 to 2.69)	2.55 (2.39 to 2.70)
Physical function impairment	3.23 (3.05 to 3.42)	3.30 (3.11 to 3.48)
Sleep	2.91 (2.75 to 3.06)	2.85 (2.70 to 3.01)

Population analysed: The analytic cohort includes trial participants who completed 2 or more NRS assessments and reported at least 1 NRS score \>= 4/10

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline to end of study participation for up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study) for all participants. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care (Control)	0 of 16,180 (0%)	0 of 16,180 (0%)	2,214 of 16,180
EHR-facilitated Collaborative Care (Intervention)	0 of 24,874 (0%)	0 of 24,874 (0%)	3,192 of 24,874

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32503661Finney Rutten LJ, Ruddy KJ, Chlan LL, Griffin JM, Herrin J, Leppin AL, Pachman DR, Ridgeway JL, Rahman PA, Storlie CB, Wilson PM, Cheville AL. Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2). Trials. 2020 Jun 5;21(1):480. doi: 10.1186/s13063-020-04335-w.
Derived from this study: PubMed 41344348Cheville AL, Herrin J, Pachman DR, Grzegorczyk V, Kroenke K, Ridgeway JL, Minteer SA, Austin JD, Griffin JM, Chlan L, Tofthagen C, Mitchell SA, Smith A, Ruddy KJ. Electronic health record-facilitated symptom surveillance and collaborative care intervention in oncology (E2C2): a cluster-randomised, population-level, stepped-wedge, pragmatic trial. Lancet Oncol. 2026 Jan;27(1):125-136. doi: 10.1016/S1470-2045(25)00526-1. Epub 2025 Dec 1.
Derived from this study: PubMed 40903741Minteer SA, Ridgeway JL, Pachman DR, Austin JD, Griffin JM, Ruddy KJ, Cheville AL. Barriers and facilitators to using practice facilitators to implement a remote cancer symptom management intervention: a mixed methods study. BMC Health Serv Res. 2025 Sep 3;25(1):1189. doi: 10.1186/s12913-025-13378-1.
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 39106420Austin JD, Finney Rutten LJ, Fischer K, Ridgeway J, Minteer S, Griffin JM, Pachman DR, Ruddy KJ, Cheville A. Advancing Care Team Adoption of Electronic Health Record Systems for Cancer Symptom Management: Findings From a Hybrid Type II, Cluster-Randomized, Stepped-Wedge Trial. JCO Oncol Pract. 2025 Feb;21(2):209-217. doi: 10.1200/OP.24.00280. Epub 2024 Aug 6.
Derived from this study: PubMed 38380342Ridgeway JL, Cheville AL, Fischer KJ, Tesch NK, Austin JD, Minteer SA, Pachman DR, Chlan LL, Ruddy KJ, Griffin JM. Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention. Contemp Clin Trials Commun. 2024 Feb 9;38:101269. doi: 10.1016/j.conctc.2024.101269. eCollection 2024 Apr.
Derived from this study: PubMed 36738867Kroenke K, Lam V, Ruddy KJ, Pachman DR, Herrin J, Rahman PA, Griffin JM, Cheville AL. Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer. J Pain Symptom Manage. 2023 May;65(5):367-377. doi: 10.1016/j.jpainsymman.2023.01.020. Epub 2023 Feb 2.

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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.

Andrea L Cheville principal investigator

Mayo Clinic in Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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 7 Oct 2025. 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?

Yes. Results are posted in the registry (first posted 7 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. (time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)). The study lists 2 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 NCT03892967, which also lists 7 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 7 Oct 2025.