UNTIRE: Cancer-related Fatigue With Digital Treatment

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05584540
• Other study ID #: 21-421
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: Dana-Farber Cancer Institute
• Contact: Nina N Grenon, DNP, AOCN
• Phone: (617) 632-5939
• Email: ngrenon[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Fatigue

Intervention

Behavioral:
• UNTIRE App
Digital therapeutic application

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Ratings	Patient's cancer related fatigue (CRF) will be described at baseline and at 4, 8, 12 weeks, and 6 months of treatment with the Untire app measured by The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) and its different subscale (e.g. physical, social, family, emotional, functional well-being, etc.)[13].	Baseline and at 4, 8, and 12 weeks.
Primary	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	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