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Trial record 1 of 1 for:    Untire | Texas, United States
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Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

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ClinicalTrials.gov Identifier: NCT03809130
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Malignant Neoplasm Other: Internet-Based Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Other: Internet-Based Intervention
Use Untire application after baseline up to 6 months

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
Other: Internet-Based Intervention
Use Untire application after 3 months up to 6 months

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1 [ Time Frame: 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 :
  1. Total days on which the patient logged in to the app [ Time Frame: 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.

  2. Total number of activities completed on the app [ Time Frame: 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.

  3. Total number of completed assessments on the app [ Time Frame: 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.

  4. Change in negative affect (delta-NA) between T0-T1 [ Time Frame: Baseline up to 3 months ]
    The linear model described for the primary objective will be repeated.

  5. Change in positive affect (delta (PA) between T0-T1 [ Time Frame: Baseline up to 3 months ]
    The linear model described for the primary objective will be repeated.

  6. Change in depressive symptoms (delta-depr) between T0 and T1 [ Time Frame: Baseline up to 3 months ]
    The linear model described for the primary objective will be repeated.

  7. Personality traits [ Time Frame: 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.

  8. Genotypes [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809130


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Cobi J Heijnen M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03809130     History of Changes
Other Study ID Numbers: 2018-0175
NCI-2018-02992 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0175 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Neoplasms
Signs and Symptoms