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Completed

NCT Number: NCT03892967

Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical 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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Participate in interview

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Anxiety Score

    Time frame: 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.

  2. Change in Depression Score

    Time frame: 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.

  3. Change in Average Pain Interference Over the Past Week

    Time frame: 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.

  4. Change in Physical Function Score

    Time frame: 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.

  5. 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)

    ER visits, hospitalizations, and ICU admissions

  6. 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 doses of docetaxel and cyclophosphamide administered.

  7. Number of Deceased Participants

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2019
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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