UNTIRE App for Cancer-Related Fatigue

Overseen By Nina N Grenon, DNP, AOCN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Dexamethasone, Methylphenidate

Disqualifiers: Surveillance, End of life care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

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).

Research Team

Nina N Grenon

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with recurrent colorectal cancer who are currently undergoing treatment. Participants must own a smartphone or iPad, be able to read and speak English at a basic level, and experience fatigue related to their cancer.

Inclusion Criteria

Owns a smart phone or iPad

A score of 1 or greater on the PRO CTACE DFCI fatigue (questions 53a or 53b)

Speak and read English at a 6th grade level or higher

Exclusion Criteria

Patients in Surveillance

I am taking dexamethasone for reasons other than nausea control.

I am taking Ritalin for cancer-related fatigue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Untire app as a self-managed digital treatment for cancer-related fatigue, with check-in meetings to assess app usage and progress

12 weeks

Check-in meetings at weeks 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final check-in 6 months post baseline

6 months

Final check-in 6 months post baseline

Treatment Details

Interventions

• UNTIRE App

Trial Overview The study is testing the 'Untire' app, designed as a digital tool to help manage Cancer Related Fatigue (CRF) in patients with colorectal cancer. The research will assess if the app is user-friendly and effective in reducing fatigue.

Participant Groups

Group I: UNTIRE App Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+