Clinical trial NCT03809130: Effectiveness of an Online Intervention Targeting Cancer-related Fatigue
Official title: Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer Survivor
Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-01-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well Untire application intervention works in reducing cancer-related fatigue in cancer patients and survivors.The Untire application focuses on themes that have been identified as causing or contributing to cancer-related fatigue. It may provide information and tips to improve lifestyle, give exercises for body and mind to increase energy levels, offer weekly reports to measure progress, and offer access to an online support community.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1
timeFrame: Baseline up to 3 months
Secondary outcomes:
measure: Total days on which the patient logged in to the app
timeFrame: Up to 6 months
measure: Total number of activities completed on the app
timeFrame: Up to 6 months
measure: Total number of completed assessments on the app
timeFrame: Up to 6 months
measure: Change in negative affect (delta-NA) between T0-T1
timeFrame: Baseline up to 3 months
measure: Change in positive affect (delta (PA) between T0-T1
timeFrame: Baseline up to 3 months
measure: Change in depressive symptoms (delta-depr) between T0 and T1
timeFrame: Baseline up to 3 months
measure: Personality traits
timeFrame: Up to 6 months
measure: Genotypes
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Cobi J Heijnen
role: PRINCIPAL_INVESTIGATOR
References: