UNTIRE: Cancer-related Fatigue With Digital Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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The UNTIRE App Trial: The Feasibility of Using the Untire App for the Colorectal Cancer Patient to Manage Their Cancer Related Fatigue

Conditions
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Colorectal Cancer, Fatigue

Intervention / Treatment
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* Behavioral: UNTIRE App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UNTIRE App<br>At baseline meeting participants will answer questionnaires and be introduced and instructed on self-managed use of Untire app treatment program. Participants will then have check in meetings assessing app usage and progress on weeks 4, 8 and 12 post baseline, then a final check-in 6 months post baseline. | Behavioral: UNTIRE App<br>* Digital therapeutic application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | Primary outcome is feasibility. Feasibility will be described as the number and percentage of enrolled patients that used the app more than once. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSQ-I Score | Acceptability will be evaluated using the number and percentage of people that scored more than 16 points on the Client Satisfaction Questionnaire - Internet (CSQ- I). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Fatigue