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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02992 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0175 | Other Identifier | M D Anderson Cancer Center |
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Terminated Per PI
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Untire application) | Experimental | Patients use Untire application intervention after baseline up to 6 months. |
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| Arm II (Untire application) | Active Comparator | Patients use Untire application intervention after 3 months up to 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Use Untire application after baseline up to 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cobi J Heijnen | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Internet-Based Intervention | Other | Use Untire application after 3 months up to 6 months |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |