Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
Intervention: Internet-Based Intervention (Other)
Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Intervention: Questionnaire Administration (Other)
Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Intervention: Internet-Based Intervention (Other)
Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Intervention: Quality-of-Life Assessment (Other)
Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
Intervention: Quality-of-Life Assessment (Other)
Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Total number of activities completed on the app(Up to 6 months)
- Total number of completed assessments on the app(Up to 6 months)
- Change in negative affect (delta-NA) between T0-T1(Baseline up to 3 months)
- Change in depressive symptoms (delta-depr) between T0 and T1(Baseline up to 3 months)
- Genotypes(Up to 6 months)
- Change in positive affect (delta (PA) between T0-T1(Baseline up to 3 months)
- Total days on which the patient logged in to the app(Up to 6 months)
- Personality traits(Up to 6 months)