UNTIRE: Cancer-related Fatigue With Digital Treatment

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer; Fatigue
• Interventions: Behavioral: UNTIRE App

• Registration Number: NCT05584540
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Study Start: 2025-01-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UNTIRE App	UNTIRE App	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.

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	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 Outcome Measures

Name	Time	Method
CSQ-I Score	3 months	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).

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States