Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

Malignant Neoplasm Clinical Trial

Official title:

Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03809130
• Other study ID #: 2018-0175
• Secondary ID: NCI-2018-0299220
• Status: Terminated
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: July 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Survivor
• Fatigue
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Internet-Based Intervention
Use Untire application after baseline up to 6 months
• Internet-Based Intervention
Use Untire application after 3 months up to 6 months
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1	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.	Baseline up to 3 months
Secondary	Total days on which the patient logged in to the app	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.	Up to 6 months
Secondary	Total number of activities completed on the app	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.	Up to 6 months
Secondary	Total number of completed assessments on the app	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.	Up to 6 months
Secondary	Change in negative affect (delta-NA) between T0-T1	The linear model described for the primary objective will be repeated.	Baseline up to 3 months
Secondary	Change in positive affect (delta (PA) between T0-T1	The linear model described for the primary objective will be repeated.	Baseline up to 3 months
Secondary	Change in depressive symptoms (delta-depr) between T0 and T1	The linear model described for the primary objective will be repeated.	Baseline up to 3 months
Secondary	Personality traits	Personality traits and their interaction with group will be added as independent variables to the linear model described for the primary objective.	Up to 6 months
Secondary	Genotypes	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.	Up to 6 months

External Links

•   MD Anderson Cancer Center Website