Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

PRIMARY OBJECTIVES:

I. To assess the effectiveness of an online multidisciplinary psychological training program
delivered via a smartphone-based application (the Untire app) in reducing patient-reported
fatigue in cancer patients and survivors.

SECONDARY OBJECTIVES:

I. To determine the dose-response association between use of the Untire app and reduction in
patient-reported fatigue severity.

II. To explore whether changes in positive and negative affect, depressive symptoms interact
with the effects of the Untire app on fatigue severity.

III. To explore the predictive value of genetic markers (single-nucleotide polymorphisms) and
personality characteristics for effectiveness of the Untire app in reducing patient-reported
fatigue.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients use Untire application intervention after baseline up to 6 months.

ARM II: Patients use Untire application intervention after 3 months up to 6 months.

Inclusion Criteria:

- Patients who present at the Cancer-Related Fatigue Clinic or the Psychiatric Oncology
Clinic for an initial consult

- Patients who speak and read English

- Patients who are willing and able to review, understand, and provide written consent

- Patients who agree to comply with all study procedures

- Patients who are in possession of a smartphone or tablet that supports the Untire app
software

- Patients rating their current fatigue severity as moderate to severe (= or > 4 on a
0-10 scale), assessed as part of the clinics' screening procedure

Exclusion Criteria:

- Case report of diagnosis of a formal thought disorder (e.g., schizophrenia)