Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

Not Applicable

Terminated

• Conditions: Malignant Neoplasm; Cancer Survivor
• Interventions: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03809130
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Untire application)	Questionnaire Administration	Patients use Untire application intervention after baseline up to 6 months.
Arm II (Untire application)	Internet-Based Intervention	Patients use Untire application intervention after 3 months up to 6 months.
Arm II (Untire application)	Questionnaire Administration	Patients use Untire application intervention after 3 months up to 6 months.
Arm I (Untire application)	Quality-of-Life Assessment	Patients use Untire application intervention after baseline up to 6 months.
Arm I (Untire application)	Internet-Based Intervention	Patients use Untire application intervention after baseline up to 6 months.
Arm II (Untire application)	Quality-of-Life Assessment	Patients use Untire application intervention after 3 months up to 6 months.

Primary Outcome Measures

Name	Time	Method
Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1	Baseline up to 3 months	The effect of the intervention on fatigue will be analyzed with a generalized linear model, including CIS-20 sum score at T1 as the dependent variable, CIS-20 sum score at T0 as covariate, and group (intervention versus wait-list control) as independent variable.

Secondary Outcome Measures

Name	Time	Method
Total number of activities completed on the app	Up to 6 months	Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.
Total number of completed assessments on the app	Up to 6 months	Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.
Change in negative affect (delta-NA) between T0-T1	Baseline up to 3 months	The linear model described for the primary objective will be repeated.
Change in depressive symptoms (delta-depr) between T0 and T1	Baseline up to 3 months	The linear model described for the primary objective will be repeated.
Genotypes	Up to 6 months	Genotypes will be dichotomized (presence of minority alleles in the gene of interest) and added as covariates and in interaction with group to the models.
Change in positive affect (delta (PA) between T0-T1	Baseline up to 3 months	The linear model described for the primary objective will be repeated.
Total days on which the patient logged in to the app	Up to 6 months	Change in fatigue between T0 and T1 for the intervention group and between T1 and T2 for the wait-list control group will be entered as dependent variable in multiple regression models, with group allocation as covariate. Separate models will be computed including the different app-usage metrics assessed between T0 -T1 for the intervention group and T1-T2 for the control group as independent variable. These models will additionally be calculated for change in fatigue and use of the app between T0 and T2, for patients in the intervention arm only.
Personality traits	Up to 6 months	Personality traits and their interaction with group will be added as independent variables to the linear model described for the primary objective.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States