Condition or disease | Intervention/treatment | Phase |
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Cancer Survivor Malignant Neoplasm | Other: Internet-Based Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 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 |
Actual Primary Completion Date : | June 20, 2019 |
Actual Study Completion Date : | June 20, 2019 |
Arm | Intervention/treatment |
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Experimental: Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
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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
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Active Comparator: Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Cobi J Heijnen | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | January 16, 2019 | ||||
First Posted Date ICMJE | January 18, 2019 | ||||
Last Update Posted Date | July 29, 2020 | ||||
Actual Study Start Date ICMJE | December 10, 2018 | ||||
Actual Primary Completion Date | June 20, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effectiveness of an Online Intervention Targeting Cancer-related Fatigue | ||||
Official Title ICMJE | Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
27 | ||||
Original Estimated Enrollment ICMJE |
400 | ||||
Actual Study Completion Date ICMJE | June 20, 2019 | ||||
Actual Primary Completion Date | June 20, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03809130 | ||||
Other Study ID Numbers ICMJE | 2018-0175 NCI-2018-02992 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0175 ( Other Identifier: M D Anderson Cancer Center ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |