N/A
N=160
Lay Health Worker Engage, Educate, and Encourage Patients to Share
End of Life · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03699748 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey — 74.1; 73.5; 70.3; 80.7 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lay Health Worker Intervention (Behavioral); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey |
73.3; 84.4 | 0.001 sig |
| SECONDARY Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey |
23; 64 | — |
| SECONDARY Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey |
41; 38 | — |
| SECONDARY Patient Activation Using the Patient Activation Measure Survey |
57.6; 77.7 | — |
| SECONDARY Patient Activation Using the Patient Activation Measure Survey |
57.6; 77.7 | — |
| SECONDARY Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey |
73.3; 84.4 | 0.001 sig |
| SECONDARY Emergency Department Visit (Chart Review) |
3; 1 | — |
| SECONDARY Emergency Department Visit (Chart Review) |
3; 1 | — |
| SECONDARY Emergency Department Visit (Chart Review) |
3; 1 | — |
| SECONDARY Hospitalization Visit (Chart Review) |
16; 32 | — |
| SECONDARY Hospitalization Visits (Chart Review) |
3; 6 | — |
| SECONDARY Hospitalization Visits (Chart Review) |
3; 6 | — |
| SECONDARY Advance Directive Documentation (Chart Review) |
55; 72 | — |
| SECONDARY Advance Directive Documentation (Chart Review) |
55; 72 | — |
| SECONDARY Physician Orders for Life Sustaining Treatment (Chart Review) |
13; 33 | — |
| SECONDARY Physician Orders for Life Sustaining Treatment (Chart Review) |
13; 33 | — |
| SECONDARY Goals of Care Documentation (Chart Review) |
23; 71 | — |
| SECONDARY Goals of Care Documentation (Chart Review) |
23; 71 | — |
| SECONDARY Total Costs of Care |
153,980.60; 72,585.06 | — |
| SECONDARY Total Costs of Care End of Life |
6,211; 5,471 | — |
| SECONDARY Palliative Care Use (Chart Review) |
6; 16 | — |
| SECONDARY Palliative Care Use (Chart Review) |
6; 16 | — |
| SECONDARY Palliative Care Use (Chart Review) |
6; 16 | — |
| SECONDARY Hospice Use (Chart Review) |
6; 16 | — |
| SECONDARY Hospice Use (Chart Review) |
6; 16 | — |
| SECONDARY Hospice Use (Chart Review) |
6; 16 | — |
| SECONDARY Survival (Chart Review) |
— | — |
| SECONDARY Survival (Chart Review) |
— | — |
| SECONDARY Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey |
41; 38 | — |
Summary
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed patients with a cancer diagnosis.
- Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
- The patients must be 18 years or older.
- Patients must have the capacity to verbally consent.
Exclusion Criteria
- Inability to consent to the study due to lack of capacity as documented by the referring physician.
- Patients without a newly diagnosed malignancy or patients without relapse of disease.
- Patients not eligible for Fund benefits.
Patients without a newly diagnosed malignancy or patients without relapse of disease.
Data sourced from ClinicalTrials.gov (NCT03699748). 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.