NCT04107116

Enhancing Community Capacity to Improve Cancer Care Delivery

Completed NA Results posted Last updated 27 February 2025

What this trial tests

NA trial testing Program participants in End of Life in 832 participants. Completed in 30 September 2021.

Timeline

1 November 2016

Primary endpoint
30 September 2020

30 September 2021

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	triple
Primary purpose	health services research
Enrollment	832
Start date	1 November 2016
Primary completion	30 September 2020
Estimated completion	30 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Program participants
• Usual Care

Conditions studied

• End of Life — all drugs for End of Life →
• Cancer — all drugs for Cancer →

Sponsor

Stanford University

Who can join

18 and older, any sex, with End of Life or Cancer. 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.

Edmonton Symptom Assessment Scale (ESAS) Symptom Screen Primary · Baseline (at time of patient enrollment)

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).

Group	Value	95% CI
Intervention Group Arm	7	0 – 10
Control Group Arm	7	0 – 10

Edmonton Symptom Assessment Scale (ESAS) Symptom Screen Primary · 6 months after patient enrollment

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).

Group	Value	95% CI
Intervention Group Arm	8.2	0 – 9
Control Group Arm	9.8	5 – 10

Edmonton Symptom Assessment Scale (ESAS) Symptom Screen Primary · 12 months after patient enrollment

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).

Group	Value	95% CI
Intervention Group Arm	7	0 – 7
Control Group Arm	9.8	6 – 10

Personal Health Questionnaire-9 (PHQ-9) Depression Screen Primary · Baseline (at time of patient enrollment)

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.

Group	Value	95% CI
Intervention Group Arm	2.9	0 – 27
Control Group Arm	2.7	0 – 27

Personal Health Questionnaire-9 (PHQ-9) Depression Screen Primary · 6 months after patient enrollment

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.

Group	Value	95% CI
Intervention Group Arm	2.5	0 – 27
Control Group Arm	2.9	0 – 27

Personal Health Questionnaire-9 (PHQ-9) Depression Screen Primary · 12 months after patient enrollment

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.

Group	Value	95% CI
Intervention Group Arm	1.9	0 – 27
Control Group Arm	3.9	0 – 27

Incidence of Emergency Department Visits Within 12-months After Patient Enrollment (Chart Review) Secondary · 12 months after patient enrollment

Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the number of visits (per 1000 members/year) with emergency department visits between study arms.

Group	Value	95% CI
Intervention Group Arm	0.43
Control Group Arm	0.57

Incidence of Hospitalization Visits Within 12 Months After Patient Enrollment (Chart Review) Secondary · 12 months after patient enrollment

Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the number of visits (per 1000 members/year) with hospital use between study arms.

Group	Value	95% CI
Intervention Group Arm	0.54
Control Group Arm	0.72

Number of Patients With a Hospice Consult Within 12-months After Patient Enrollment (Chart Review) Secondary · 12 months after patient enrollment

Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

Group	Value	95% CI
Intervention Group Arm	207
Control Group Arm	101

Total Health Care Costs (Claims Review) Secondary · 12 months after patient enrollment

Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.

Group	Value	95% CI
Intervention Group Arm	17,869	6,865 – 32,540
Control Group Arm	18,473	6,415 – 37,910

Number of Patients With an Acute Care Facility Death (Chart Review) Secondary · 30 days prior to death for patients who died at 12-months follow-up

Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.

Group	Value	95% CI
Intervention Group Arm	18
Control Group Arm	30

Number of Emergency Department Visit in the Last 30 Days of Life (Chart Review) Secondary · 30 days prior to death for patients who died at 12-months follow-up

Emergency Department (acute care) use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.

Group	Value	95% CI
Intervention Group Arm	0.10	± 0.30
Control Group Arm	0.30	± 0.46

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.