Immunotherapy & Me

NCT03347058 | Completed

• 1 other identifier: CSC-IO-0102
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 5

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. 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. 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.

Conditions

Cancer

Keywords

immunotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Self-reported patient confidence in accessing resources

  One year

Study Arms (1)

Supportive programming

OTHER

Access to a suite of resources, including digital tools, person-to-person support, and educational resources

Other: Supportive programming

Interventions

Supportive programming OTHER

Access to a suite of resources, including digital tools, person-to-person support, and educational resources

Supportive programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

Catholic Health Initiatives

Englewood, Colorado, 80112, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

OHC

Cincinnati, Ohio, 45242, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Linda House, RN, BSN, MSM

  Cancer Support Community

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Cancer Support Community

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 20, 2017
• Study Start: December 1, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)