Enhancing Community Capacity to Improve Cancer Care Delivery

NCT04107116 | Completed Results

• 1 other identifier: 455
• Study Type: interventional
• Target: 832
• Locations: 1 country
• Sites: 1

Brief Summary

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a a lay health worker (LHW)-led symptom screening intervention was developed for patients with advanced cancer. This intervention will be expanded to all patients with cancer and the LHW will be trained to refer patients to palliative care and behavioral health. This intervention will evaluate the effect on symptom-burden, survival, healthcare use, and total costs.

Conditions

End of Life; Cancer

Keywords

cancer end of life patient-centered

Outcome Measures

Primary Outcomes (6)

• Edmonton Symptom Assessment Scale (ESAS) Symptom Screen

  Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  Baseline (at time of patient enrollment)

• Edmonton Symptom Assessment Scale (ESAS) Symptom Screen

  Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  6 months after patient enrollment

• Edmonton Symptom Assessment Scale (ESAS) Symptom Screen

  Each patient will receive a quantitative symptom assessment survey (Edmonton Symptom Assessment Scale). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).

  12 months after patient enrollment

• Personal Health Questionnaire-9 (PHQ-9) Depression Screen

  Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at baseline. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.

  Baseline (at time of patient enrollment)

• Personal Health Questionnaire-9 (PHQ-9) Depression Screen

  Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 6 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.

  6 months after patient enrollment

• Personal Health Questionnaire-9 (PHQ-9) Depression Screen

  Each patient will receive a Personal Health Questionnaire-9 (PHQ-9) at 12 months. PHQ-9 is measured on a scale of 0-27, where scores of 5, 10, 15, and 20 are cut-points for mild, moderate, moderately severe and severe depression, respectively.

  12 months after patient enrollment

Secondary Outcomes (9)

• Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review)

  12 months after patient enrollment

• Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review)

  12 months after patient enrollment

• Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review)

  12 months after patient enrollment

• Total Health Care Costs (Claims Review)

  12 months after patient enrollment

• Number of Patients With an Acute Care Facility Death (Chart Review)

  30 days prior to death for patients who died at 12-months follow-up

Study Arms (2)

Intervention Group Arm

EXPERIMENTAL

Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months.

Behavioral: Program participants; Other: Usual Care

Control Group Arm

ACTIVE COMPARATOR

The control group arm will receive usual care as provided by their local oncologists.

Other: Usual Care

Interventions

Program participants BEHAVIORAL

The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.

Intervention Group Arm

Usual Care OTHER

Usual care as provided by local oncologists

Control Group Arm; Intervention Group Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with cancer
• Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
• Must be 18 years or older.
• Must have capacity to verbally consent

You may not qualify if:

• Inability to consent to the study due to lack of capacity as documented by the referring physician.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Oncology Institute for Hope and Innovation

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Death; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Patients in the intervention group were compared with a retrospective cohort of patients; the practice setting was limited to 9 clinics associated with one institution; there may be differences in unmeasured variables, which would bias the findings; could not measure the physician assistant interventions made in response to symptoms. Could not assess the result of the intervention on intermediary variables due to only collecting data on palliative care and behavioral health.

Results Point of Contact

• Title: Manali I Patel, MD MPH MS
• Organization: Stanford University School of Medicine

manalip@stanford.edu

650-723-4000

Study Officials

• Manali I Patel, MD MPH MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 27, 2019
• Study Start: November 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)