Effectiveness of an Online Intervention Targeting Cancer-related Fatigue
NCT ID: NCT03809130
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
27 participants
INTERVENTIONAL
2018-12-10
2019-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Internet-Based Intervention
Use Untire application after baseline up to 6 months
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (Untire application)
Patients use Untire application intervention after 3 months 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Cobi J Heijnen
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-02992
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0175
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0175
Identifier Type: -
Identifier Source: org_study_id
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