18 and older, any sex, with Hematopoietic and Lymphoid Cell Neoplasm or Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.Primary· 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.
Anxiety
Group
Value
95% CI
Usual Care (Control)
2.09
2.05 – 2.13
EHR-facilitated Collaborative Care (Intervention)
1.98
1.94 – 2.02
Depression
Group
Value
95% CI
Usual Care (Control)
1.90
1.86 – 1.93
EHR-facilitated Collaborative Care (Intervention)
1.81
1.78 – 1.85
Fatigue
Group
Value
95% CI
Usual Care (Control)
3.27
3.22 – 3.32
EHR-facilitated Collaborative Care (Intervention)
3.21
3.15 – 3.26
Pain
Group
Value
95% CI
Usual Care (Control)
2.18
2.12 – 2.24
EHR-facilitated Collaborative Care (Intervention)
2.14
2.09 – 2.20
Impaired Physical Function
Group
Value
95% CI
Usual Care (Control)
2.75
2.69 – 2.80
EHR-facilitated Collaborative Care (Intervention)
2.78
2.72 – 2.84
Sleep
Group
Value
95% CI
Usual Care (Control)
2.46
2.41 – 2.51
EHR-facilitated Collaborative Care (Intervention)
2.39
2.34 – 2.44
Physical Function Numerical Rating Scale (NRS) ScoresPrimary· 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.
Anxiety
Group
Value
95% CI
Usual Care (Control)
2.51
2.05 – 2.63
EHR-facilitated Collaborative Care (Intervention)
2.37
2.24 – 2.49
Depression
Group
Value
95% CI
Usual Care (Control)
2.27
2.14 – 2.40
EHR-facilitated Collaborative Care (Intervention)
2.17
2.04 – 2.30
Fatigue
Group
Value
95% CI
Usual Care (Control)
3.96
3.80 – 4.12
EHR-facilitated Collaborative Care (Intervention)
3.87
3.72 – 4.03
Pain
Group
Value
95% CI
Usual Care (Control)
2.53
2.37 – 2.69
EHR-facilitated Collaborative Care (Intervention)
2.55
2.39 – 2.70
Physical function impairment
Group
Value
95% CI
Usual Care (Control)
3.23
3.05 – 3.42
EHR-facilitated Collaborative Care (Intervention)
3.30
3.11 – 3.48
Sleep
Group
Value
95% CI
Usual Care (Control)
2.91
2.75 – 3.06
EHR-facilitated Collaborative Care (Intervention)
2.85
2.70 – 3.01
Change in Anxiety ScoreSecondary· 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.
Group
Value
95% CI
Usual Care (Control)
51.86451
± 9.036415
EHR-facilitated Collaborative Care (Intervention)
51.35445
± 9.303022
Change in Depression ScoreSecondary· 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.
Group
Value
95% CI
Usual Care (Control)
49.05267
± 8.642265
EHR-facilitated Collaborative Care (Intervention)
48.49032
± 8.666607
Change in Average Pain Interference Over the Past WeekSecondary· 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.
Group
Value
95% CI
Usual Care (Control)
52.57027
± 9.80923
EHR-facilitated Collaborative Care (Intervention)
53.2717
± 9.918807
Change in Physical Function ScoreSecondary· 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.
Group
Value
95% CI
Usual Care (Control)
43.83007
± 9.641792
EHR-facilitated Collaborative Care (Intervention)
43.18325
± 9.561469
Health Care UtilizationSecondary· 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
Hospitalizations
Group
Value
95% CI
Usual Care (Control)
3415
EHR-facilitated Collaborative Care (Intervention)
3009
ED visits
Group
Value
95% CI
Usual Care (Control)
4331
EHR-facilitated Collaborative Care (Intervention)
3495
ICU admissions
Group
Value
95% CI
Usual Care (Control)
940
EHR-facilitated Collaborative Care (Intervention)
722
Adherence to Cancer TreatmentSecondary· 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 doses of docetaxel administered
Group
Value
95% CI
Usual Care (Control)
3.530303
± 1.088281
EHR-facilitated Collaborative Care (Intervention)
3.765625
± 0.6458148
Number of doses of cyclophosphamide administered
Group
Value
95% CI
Usual Care (Control)
3.707071
± 0.973151
EHR-facilitated Collaborative Care (Intervention)
3.78125
± 0.7310601
Number of Deceased ParticipantsSecondary· 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
Group
Value
95% CI
Usual Care (Control)
2214
EHR-facilitated Collaborative Care (Intervention)
3192
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 7 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03892967.