Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. 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.
Interventions
OTHERInterview
Participate in interview
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Pain Interference Over the Past Week | Baseline to 46 months | 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. |
| Change in Physical Function Score | Baseline to 46 months | 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. |
| Change in Anxiety Score | Baseline to 46 months | 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. |
| Adherence to Cancer Treatment | Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study) | Number of doses of docetaxel and cyclophosphamide administered. |
| Number of Deceased Participants | Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study) | Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index |
| Health Care Utilization | Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study) | ER visits, hospitalizations, and ICU admissions |
| Change in Depression Score | Baseline to 46 months | 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. |
Countries
United States
Participant flow
Recruitment details
From March 2019 to January 2023, 50,207 patients (in fifteen clusters) were enrolled and administered ePROMs in association with oncology visits.
Pre-assignment details
Participants could be enrolled for more than one Period over the course of the study.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (Control) Participants were administered ePROM surveillance alone. | 16,180 |
| EHR-facilitated Collaborative Care (Intervention) Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan. | 19,084 |
| Total | 35,264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Step 1: 4/1/2019-9/30/2019 | Participants did not answer at least two surveys and were not included in the analytic cohort | 1,283 | 1,728 | 1,823 | 1,443 | 728 |
| Step 2: 10/1/2019-5/31/2020 | Participants did not answer at least two surveys and were not included in the analytic cohort | 474 | 726 | 774 | 552 | 366 |
| Step 3: 6/1/2020-1/31/2021 | Participants did not answer at least two surveys and were not included in the analytic cohort | 710 | 993 | 910 | 739 | 280 |
| Step 4: 2/1/2021-9/30/2021 | Participants did not answer at least two surveys and were not included in the analytic cohort | 585 | 893 | 962 | 830 | 315 |
| Step 5: 10/1/2021-5/31/2022 | Participants did not answer at least two surveys and were not included in the analytic cohort | 508 | 845 | 1,025 | 751 | 302 |
| Step 6: 6/1/2022-1/31/2023 | Participants did not answer at least two surveys and were not included in the analytic cohort | 797 | 1,177 | 1,398 | 1,069 | 486 |
Baseline characteristics
| Characteristic | Usual Care (Control) | EHR-facilitated Collaborative Care (Intervention) | Total |
|---|---|---|---|
| Age, Customized Age <=35 | 566 Participants | 646 Participants | 1212 Participants |
| Age, Customized Age 35-45 | 1200 Participants | 1514 Participants | 2714 Participants |
| Age, Customized Age 45-55 | 2336 Participants | 2877 Participants | 5213 Participants |
| Age, Customized Age 55-65 | 4188 Participants | 4993 Participants | 9181 Participants |
| Age, Customized Age 65-75 | 4933 Participants | 5871 Participants | 10804 Participants |
| Age, Customized Age 75-85 | 2466 Participants | 2689 Participants | 5155 Participants |
| Age, Customized Age >85 | 491 Participants | 494 Participants | 985 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15982 Participants | 18816 Participants | 34798 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 189 Participants | 323 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 64 Participants | 79 Participants | 143 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 62 Participants | 86 Participants | 148 Participants |
| Race (NIH/OMB) Asian | 248 Participants | 357 Participants | 605 Participants |
| Race (NIH/OMB) Black or African American | 149 Participants | 180 Participants | 329 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 246 Participants | 266 Participants | 512 Participants |
| Race (NIH/OMB) White | 15468 Participants | 18189 Participants | 33657 Participants |
| Region of Enrollment United States | 16180 participants | 19084 participants | 35264 participants |
| Sex: Female, Male Female | 9621 Participants | 11138 Participants | 20759 Participants |
| Sex: Female, Male Male | 6559 Participants | 7946 Participants | 14505 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2,214 / 16,180 | 3,192 / 24,874 |
| other Total, other adverse events | 0 / 16,180 | 0 / 24,874 |
| serious Total, serious adverse events | 0 / 16,180 | 0 / 24,874 |
Outcome results
Primary
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.
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Population: The analytic cohort includes trial participants who completed 2 or more NRS assessments and reported at least 1 NRS score \>= 4/10
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care (Control) | Physical Function Numerical Rating Scale (NRS) Scores | Physical function impairment | 3.23 units on a scale |
| Usual Care (Control) | Physical Function Numerical Rating Scale (NRS) Scores | Sleep | 2.91 units on a scale |
| Usual Care (Control) | Physical Function Numerical Rating Scale (NRS) Scores | Anxiety | 2.51 units on a scale |
| Usual Care (Control) | Physical Function Numerical Rating Scale (NRS) Scores | Depression | 2.27 units on a scale |
| Usual Care (Control) | Physical Function Numerical Rating Scale (NRS) Scores | Fatigue | 3.96 units on a scale |
| Usual Care (Control) | Physical Function Numerical Rating Scale (NRS) Scores | Pain | 2.53 units on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Physical Function Numerical Rating Scale (NRS) Scores | Fatigue | 3.87 units on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Physical Function Numerical Rating Scale (NRS) Scores | Physical function impairment | 3.30 units on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Physical Function Numerical Rating Scale (NRS) Scores | Depression | 2.17 units on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Physical Function Numerical Rating Scale (NRS) Scores | Sleep | 2.85 units on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Physical Function Numerical Rating Scale (NRS) Scores | Pain | 2.55 units on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Physical Function Numerical Rating Scale (NRS) Scores | Anxiety | 2.37 units on a scale |
Primary
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.
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Population: The analytic cohort includes trial participants who completed 2 or more NRS assessments.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care (Control) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Anxiety | 2.09 score on a scale |
| Usual Care (Control) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Depression | 1.90 score on a scale |
| Usual Care (Control) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Fatigue | 3.27 score on a scale |
| Usual Care (Control) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Pain | 2.18 score on a scale |
| Usual Care (Control) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Impaired Physical Function | 2.75 score on a scale |
| Usual Care (Control) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Sleep | 2.46 score on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Impaired Physical Function | 2.78 score on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Anxiety | 1.98 score on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Pain | 2.14 score on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Depression | 1.81 score on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Sleep | 2.39 score on a scale |
| EHR-facilitated Collaborative Care (Intervention) | Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. | Fatigue | 3.21 score on a scale |
Secondary
Adherence to Cancer Treatment
Number of doses of docetaxel and cyclophosphamide administered.
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)
Population: The analyses were restricted to the subgroup of patients with breast cancer being treated with docetaxel/cyclophosphamide in order to ensure comparable receipt of chemotherapeutic regimens between the comparator groups. Because docetaxel and cyclophosphamide may be first-/second-line therapy for breast cancer, a large participant subgroup that offered adequate power was chosen. Patients who crossed over from usual care to EHR-facilitated collaborative care were excluded from this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Control) | Adherence to Cancer Treatment | Number of doses of docetaxel administered | 3.530303 number of doses administered | Standard Deviation 1.088281 |
| Usual Care (Control) | Adherence to Cancer Treatment | Number of doses of cyclophosphamide administered | 3.707071 number of doses administered | Standard Deviation 0.973151 |
| EHR-facilitated Collaborative Care (Intervention) | Adherence to Cancer Treatment | Number of doses of docetaxel administered | 3.765625 number of doses administered | Standard Deviation 0.6458148 |
| EHR-facilitated Collaborative Care (Intervention) | Adherence to Cancer Treatment | Number of doses of cyclophosphamide administered | 3.78125 number of doses administered | Standard Deviation 0.7310601 |
Secondary
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.
Time frame: Baseline to 46 months
Population: Patients who answered \>=1 Anxiety PROMIS-CAT were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Control) | Change in Anxiety Score | 51.86451 score on a scale | Standard Deviation 9.036415 |
| EHR-facilitated Collaborative Care (Intervention) | Change in Anxiety Score | 51.35445 score on a scale | Standard Deviation 9.303022 |
Secondary
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.
Time frame: Baseline to 46 months
Population: Patients who answered \>=1 Pain Interference PROMIS-CAT were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Control) | Change in Average Pain Interference Over the Past Week | 52.57027 score on a scale | Standard Deviation 9.80923 |
| EHR-facilitated Collaborative Care (Intervention) | Change in Average Pain Interference Over the Past Week | 53.2717 score on a scale | Standard Deviation 9.918807 |
Secondary
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.
Time frame: Baseline to 46 months
Population: Patients who answered \>=1 Depression PROMIS-CAT were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Control) | Change in Depression Score | 49.05267 score on a scale | Standard Deviation 8.642265 |
| EHR-facilitated Collaborative Care (Intervention) | Change in Depression Score | 48.49032 score on a scale | Standard Deviation 8.666607 |
Secondary
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.
Time frame: Baseline to 46 months
Population: Patients who answered \>=1 Physical Function PROMIS-CAT were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (Control) | Change in Physical Function Score | 43.83007 score on a scale | Standard Deviation 9.641792 |
| EHR-facilitated Collaborative Care (Intervention) | Change in Physical Function Score | 43.18325 score on a scale | Standard Deviation 9.561469 |
Secondary
Health Care Utilization
ER visits, hospitalizations, and ICU admissions
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)
Population: Utilization data were available for the entire E2C2 trial cohort irrespective of ePROM completion. To assess robustness, we conducted analyses that included the full cohort, the \>=1 ePROM completers, and the \>=2 ePROM completers. In addition, we created subgroups based on residential proximity to a trial site to assess the extent of care provided at non-participating institutions. Here we report the patients who completed 1 or more surveys and resided within 120 miles from a trial site.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care (Control) | Health Care Utilization | Hospitalizations | 3415 events |
| Usual Care (Control) | Health Care Utilization | ED visits | 4331 events |
| Usual Care (Control) | Health Care Utilization | ICU admissions | 940 events |
| EHR-facilitated Collaborative Care (Intervention) | Health Care Utilization | Hospitalizations | 3009 events |
| EHR-facilitated Collaborative Care (Intervention) | Health Care Utilization | ICU admissions | 722 events |
| EHR-facilitated Collaborative Care (Intervention) | Health Care Utilization | ED visits | 3495 events |
Secondary
Number of Deceased Participants
Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index
Time frame: Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (Control) | Number of Deceased Participants | 2214 Participants |
| EHR-facilitated Collaborative Care (Intervention) | Number of Deceased Participants | 3192 Participants |