N/A
N=16,715
Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial
Hematopoietic and Lymphoid Cell Neoplasm · Malignant Solid Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03892967 ↗Enrolled (actual)
16,715
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. — 2.09; 1.98; 1.90; 1.81 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interview (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores. |
2.09; 1.98; 1.90; 1.81; 3.27; 3.21 | — |
| PRIMARY Physical Function Numerical Rating Scale (NRS) Scores |
2.51; 2.37; 2.27; 2.17; 3.96; 3.87 | — |
| SECONDARY Change in Anxiety Score |
51.86451; 51.35445 | — |
| SECONDARY Change in Depression Score |
49.05267; 48.49032 | — |
| SECONDARY Change in Average Pain Interference Over the Past Week |
52.57027; 53.2717 | — |
| SECONDARY Change in Physical Function Score |
43.83007; 43.18325 | — |
| SECONDARY Health Care Utilization |
3415; 3009; 4331; 3495; 940; 722 | — |
| SECONDARY Adherence to Cancer Treatment |
3.530303; 3.765625; 3.707071; 3.78125 | — |
| SECONDARY Number of Deceased Participants |
2214; 3192 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03892967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.