Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

Stanford University

Status: Enrolling

Conditions: Cancer; End of Life

Treatments: Behavioral: Receive redesigned team-based supportive cancer care; Other: Receive technology-based supportive cancer care

Study type: Interventional

Funder types: Other

Identifiers

NCT05297734

63646

Details and patient eligibility

About

This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

Full description

PRIMARY OBJECTIVES:

I. Greater intervention effects on health-related quality of life

SECONDARY OBJECTIVES:

I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice

OUTLINE: Sites are randomized to 1 of 2 arms.

ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.

ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.

All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.

Enrollment: 2,996 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
2. Patients must have the ability to understand and willingness to provide verbal consent.
3. Participants must speak English, Spanish, Chinese, or Vietnamese.

Exclusion criteria

1. Inability to consent to the study
2. Plans to change oncologist within 12 months
3. Employed by the practice site
4. Patients who anticipate moving from the area within 12 months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,996 participants in 2 patient groups

Technology-based supportive cancer care

Active Comparator group

Description:

Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.

Treatment:

Other: Receive technology-based supportive cancer care

Redesigned team-based supportive cancer care

Experimental group

Description:

Patients are paired with a health educator who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.

Treatment:

Behavioral: Receive redesigned team-based supportive cancer care