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OpenTrials
Completed

NCT Number: NCT03347058

Immunotherapy & 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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic Health Initiatives, Englewood, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Supportive programming

Other

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

Primary outcomes

  1. CancerSupportSource®

    Time frame: One year

    Cancer-related distress

  2. # of ER visits

    Time frame: One year

    Measured via self-report through a questionnaire developed for this study issued every 30 days

  3. # of hospitalizations

    Time frame: One year

    Measured via self-report through a questionnaire developed for this study issued every 30 days

Secondary outcomes

  1. Self-reported patient confidence in accessing resources

    Time frame: One year

    Measured with a Likert scale (Not at all confident to Extremely confident); assessed every 30 days

Sponsors and collaborators

Lead sponsor

Cancer Support Community, Research and Training Institute, Philadelphia

Other

Registry information

Acronym: IO & Me

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2017
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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