Clinical trial NCT03347058: Immunotherapy & Me
Official title: Immunotherapy & Me
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: immunotherapy
Lead sponsor: Cancer Support Community, Research and Training Institute, Philadelphia
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Immunotherapy \& Me is a pilot study to determine patient and provider needs around immunotherapy treatment, and to determine the most meaningful resources to improve patient outcomes and decrease cost. Specifically, this study aims:

1. To determine whether layering in customizable resources at the point-of-care that offer healthcare providers care-management tools to give their immunotherapy patients leads to changes in (a) patients' knowledge, attitudes, and health behaviors (including self-reported measures of self-efficacy and empowerment, cancer-related distress, quality of life, and satisfaction with the programs offered) and (b) improved clinical outcomes (including decreased hospital admissions, decreased hospital readmissions, and decreased costs associated with hospitalizations).
2. To successfully integrate the Immunotherapy \& Me program within oncology practices to provide a model framework for dissemination across other care providers. Once success is demonstrated, a turn-key model of immunotherapy patient support can be expanded to other oncology care systems.

Detailed description: As usage and indications for immunotherapy increase, there presents a critical need to identify patient-centered and practice solutions across the continuum of care. Immunotherapy \& Me is an innovative program of customizable resources that seeks to improve the patient experience by supporting the unique needs of both immunotherapy patients and the clinical staff who care for them. The Cancer Support Community (CSC) will implement this operational framework of patient and provider tools at multiple geographically and demographically diverse oncology practices.

The program will include CancerSupportSource® (CSS), a self-administered screening instrument for individuals with cancer that takes approximately 10 minutes to complete and has been validated in 300 English-speaking cancer survivors at CSC affiliates nationwide.The instrument consists of cancer-related problems (physical, social, psychological, emotional and practical) and has been demonstrated to have good internal consistency reliability. Patients are asked to rate the severity of their concerns and if they would like to talk with a staff person and/or receive additional information about their concerns. This information is used to address immediate concerns as well as to develop ongoing educational experiences that are tailored and integrated with their care.

At the end of year one, CSC will evaluate program impact, retool interventions as necessary, and pursue additional funding with the goal of extending services at existing practice sites - and scaling this turnkey model of immunotherapy treatment support.

Eligibility criteria: Inclusion Criteria:

* Receiving immunotherapy as a cancer treatment at a participating pilot site location
* English- or Spanish-speaking, or having access to a translator

Exclusion Criteria:

-

Primary outcomes:
measure: CancerSupportSource®
timeFrame: One year
measure: # of ER visits
timeFrame: One year
measure: # of hospitalizations
timeFrame: One year
Secondary outcomes:
measure: Self-reported patient confidence in accessing resources
timeFrame: One year
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Catholic Health Initiatives
state: Colorado
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Cincinnati
country: United States
facility: OHC
state: Ohio
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
Study officials:
affiliation: Cancer Support Community
name: Linda House, RN, BSN, MSM
role: PRINCIPAL_INVESTIGATOR
References: