Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Malignant Neoplasm; Cancer Survivor

Treatments: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03809130

2018-0175

NCI-2018-02992 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Arm I (Untire application)

Experimental group

Description:

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

Treatment:

Other: Internet-Based Intervention

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Internet-Based Intervention

Arm II (Untire application)

Active Comparator group

Description:

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

Treatment:

Other: Internet-Based Intervention

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Internet-Based Intervention