Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

July 27, 2020 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Internet-Based Intervention
Use Untire application after baseline up to 6 months
Other: Internet-Based Intervention
Use Untire application after 3 months up to 6 months
ACTIVE_COMPARATOR: Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Internet-Based Intervention
Use Untire application after baseline up to 6 months
Other: Internet-Based Intervention
Use Untire application after 3 months up to 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months
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.
Up to 6 months
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.
Up to 6 months
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.
Baseline up to 3 months
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.
Baseline up to 3 months
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.
Baseline up to 3 months
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.
Up to 6 months
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.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cobi J Heijnen, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-0175 (M D Anderson Cancer Center)
  • NCI-2018-02992 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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