Immunotherapy & Me

Cancer Clinical Trial

— IO & Me  

Official title:

Immunotherapy & Me

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347058
• Other study ID #: CSC-IO-0102
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2023
• Source: Cancer Support Community, Research and Training Institute, Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Supportive programming
Access to a suite of resources, including digital tools, person-to-person support, and educational resources

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	OHC	Cincinnati	Ohio
United States	Catholic Health Initiatives	Englewood	Colorado
United States	West Cancer Center	Germantown	Tennessee
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Support Community, Research and Training Institute, Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CancerSupportSource®	Cancer-related distress	One year
Primary	# of ER visits	Measured via self-report through a questionnaire developed for this study issued every 30 days	One year
Primary	# of hospitalizations	Measured via self-report through a questionnaire developed for this study issued every 30 days	One year
Secondary	Self-reported patient confidence in accessing resources	Measured with a Likert scale (Not at all confident to Extremely confident); assessed every 30 days	One year