The UNTIRE App Trial: The Feasibility of Using the Untire App for the Colorectal Cancer Patient to Manage Their Cancer Related Fatigue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Enrollment Rate
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
This research is being done to find out if using a smartphone app as digital treatment to reduce Cancer Related Fatigue is feasible and easy to use.
This research study is evaluating a smartphone application named the "Untire" app. The Untire app was designed as a digital treatment plan for people experiencing Cancer Related Fatigue (CRF).
Detailed Description
This is a single arm, pilot study evaluating the feasibility, acceptability, and effectiveness of a self-managed digital therapeutic application, the Untire App, for the treatment of cancer-related fatigue in the Colorectal (CRC) cancer patient community. The Untire app was developed by Psychology Oncologists and combines proven treatments for Cancer Related Fatigue like cognitive behavioral therapy, mindfulness exercises, physical activities, education, and positive tips. The Untire app helps a patient recognize and learn about daily behaviors, fatigue levels, and energy levels. The Untire app has been tested on all different cancer types globally and has been proven to decrease fatigue and improve overall quality of life but this is the first-time investigators are examining the strengths and weaknesses of using the Untire app as a digital treatment plan for Cancer Related Fatigue. The research study procedures include screening for eligibility and study interventions including smartphone app use and evaluations with questionnaires and follow up visits. Participants will be in this research study for up to 12 months. It is expected that about 60 people will take part in this research study.
Investigators
Nina Grenon, NP
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •\>/= 18 years of age
- •Owns a smart phone or Ipad
- •Diagnosis of Metastatic Colorectal Cancer, adenocarcinoma
- •Actively undergoing treatment for Metastatic disease
- •Speak and read English at a 6th grade level or higher
- •A score of 1 or greater on the PRO CTACE DFCI fatigue (questions 53a or 53b)
Exclusion Criteria
- •Patients in Surveillance
- •Patients receiving end of life care
- •Patients taking dexamethasone other than for the control of nausea
- •Patients taking methylphenidate (Ritalin) for the treatment of CRF
Outcomes
Primary Outcomes
Enrollment Rate
Time Frame: 3 months
Primary outcome is feasibility. Feasibility will be described as the number and percentage of enrolled patients that used the app more than once.
Secondary Outcomes
- CSQ-I Score(3 months)