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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called "Untire" to determine if it can reduce Cancer Related Fatigue (CRF) in people with metastatic colorectal cancer. CRF often makes everyday tasks exhausting, so the app provides a digital treatment plan that users manage themselves. Participants will use the app and attend check-ins to discuss their progress. Individuals may qualify if they own a smartphone or iPad and are currently receiving treatment for metastatic colorectal cancer. As an unphased trial, this study offers participants the chance to contribute to innovative digital health solutions that could enhance quality of life for many.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking dexamethasone (unless it's for nausea) or methylphenidate (Ritalin) for treating cancer-related fatigue.

What prior data suggests that the UNTIRE App is safe for reducing Cancer-Related Fatigue?

Research shows that the Untire app is a safe choice for people dealing with Cancer-Related Fatigue (CRF). Studies have found that users generally have a positive experience with the app. For instance, research on the app's German version examined its effectiveness and safety. It found that users did not report any major negative side effects while using the app.

The app helps users manage fatigue and improve their quality of life without causing harm. This indicates that the Untire app is a safe digital tool for those experiencing CRF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cancer-related fatigue, which often involve medication or physical therapy, the UNTIRE App is a digital solution that empowers patients to manage their symptoms independently. Researchers are excited about this app because it offers a convenient and accessible way for users to engage in self-care through their smartphones. The app provides structured guidance and check-ins to help patients track their progress, potentially enhancing adherence and outcomes without the need for frequent clinic visits. This innovative approach could make managing cancer-related fatigue easier and more adaptable to individual needs.

What evidence suggests that the UNTIRE App is effective for reducing Cancer Related Fatigue?

Research has shown that the Untire app, which participants in this trial will use, helps reduce cancer-related tiredness. In one study, people using the app reported an average tiredness score of 4.8, compared to 5.6 for those not using it. The app reduces negative thoughts about tiredness, lowers feelings of depression, and increases mindfulness. Another study found that users experienced noticeable improvements in the severity of their tiredness and its impact on their lives compared to non-users. This evidence suggests that the Untire app can be a useful tool for cancer patients to manage their tiredness. ^{1 2 3 6 7}

Who Is on the Research Team?

Nina N Grenon

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303515/

How does the Untire app alleviate cancer‐related fatigue? ... Untire app access reduces fatigue severity and interference mainly by decreasing fatigue catastrophizing, depression, and by increasing mindfulness.

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)03647-5/fulltext

1861P A randomized controlled trial on the efficacy and ... The intervention group experienced a significantly larger improvement at week 12, with an average fatigue score of 4.8 (SE=0.18) compared to 5.6 (SE=0.17) in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7756868/

Beating cancer‐related fatigue with the Untire mobile app Compared with the control group, the intervention group showed significantly larger improvements in fatigue severity (d = 0.40), fatigue interference (d = 0.35) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05584540

UNTIRE: Cancer-related Fatigue With Digital Treatment 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 ...

5. cancernursingtoday.com cancernursingtoday.com/post/untire-app-improves-patients-fatigue-by-supporting-psychological-health

Untire App Improves Patients' Fatigue by Supporting ... A previous analysis by the same researchers demonstrated that the app was effective at reducing fatigue. The aim of the current analysis was to ...

6. umcgresearch.org umcgresearch.org/w/untire-an-app-for-cancer-related-fatigue

Untire, an app for cancer-related fatigue ... Untire app. This study showed that a self-management app can support cancer patients and survivors in managing their fatigue and quality of ...

7. researchprotocols.org researchprotocols.org/2020/2/e15969/

Beating Cancer-Related Fatigue With the Untire Mobile App The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer ...