Colorectal Cancer, Fatigue
Conditions
Keywords
Colorectal Cancer, Fatigue
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.
Interventions
BEHAVIORALUNTIRE App
Digital therapeutic application
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Ratings | Baseline and at 4, 8, and 12 weeks. | 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.)\[13\]. |
Countries
United States
Outcome results
None listed