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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Newly diagnosed patients with a solid tumor cancer diagnosis or hematologic malignancy. 2. Patients must have the ability to understand and willingness to provide consent. 3. Participants must speak English or Spanish.

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05297734
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stanford University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	End of Life, Cancer

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Technology-based supportive cancer care

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.

Experimental: Redesigned team-based supportive cancer care

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.

Interventions

Other: - Receive technology-based supportive cancer care

All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.

Behavioral: - Receive redesigned team-based supportive cancer care

Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Not yet recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Gabrielle Rocque, MD

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