Immunotherapy & Me (IO & Me)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Supportive programming

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80112
      • Catholic Health Initiatives
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • OHC
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Supportive programming; Access to a suite of resources, including digital tools, person-to-person support, and educational resources	Other: Supportive programming; Access to a suite of resources, including digital tools, person-to-person support, and educational resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CancerSupportSource®	Cancer-related distress	One year
# of ER visits	Measured via self-report through a questionnaire developed for this study issued every 30 days	One year
# of hospitalizations	Measured via self-report through a questionnaire developed for this study issued every 30 days	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cancer Support Community, Research and Training Institute, Philadelphia

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (ACTUAL): November 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: immunotherapy
• Other Study ID Numbers: CSC-IO-0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No