Clinical trial NCT05584540: UNTIRE: Cancer-related Fatigue With Digital Treatment
Official title: The UNTIRE App Trial: The Feasibility of Using the Untire App for the Colorectal Cancer Patient to Manage Their Cancer Related Fatigue
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Fatigue
Keywords: Colorectal Cancer
Fatigue
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 3 months
Secondary outcomes:
measure: CSQ-I Score
timeFrame: 3 months
Other outcomes:
measure: The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Ratings
timeFrame: Baseline and at 4, 8, and 12 weeks.
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nina N Grenon, DNP, AOCN
role: PRINCIPAL_INVESTIGATOR
References: