Immunotherapy & Me

NCT ID: NCT03347058

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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 CancerSupportSourceĀ® (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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive programming

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

Group Type OTHER

Supportive programming

Intervention Type OTHER

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

Interventions

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Supportive programming

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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Support Community, Research and Training Institute, Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Heather Badt, MBA

President, Cancer Support Community

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda House, RN, BSN, MSM

Role: PRINCIPAL_INVESTIGATOR

Cancer Support Community

Locations

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Catholic Health Initiatives

Englewood, Colorado, United States

Site Status

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status

OHC

Cincinnati, Ohio, United States

Site Status

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

West Cancer Center

Germantown, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CSC-IO-0102

Identifier Type: -

Identifier Source: org_study_id

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