Study Stopped
Terminated Per PI
Effectiveness of an Online Intervention Targeting Cancer-related Fatigue
Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
2 other identifiers
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2018
CompletedFirst Submitted
Initial submission to the registry
January 16, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedJuly 29, 2020
July 1, 2020
6 months
January 16, 2019
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in patient-reported fatigue severity as assessed with the Checklist Individual Strength (CIS) between T0 and T1
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 Outcomes (8)
Total days on which the patient logged in to the app
Up to 6 months
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 positive affect (delta (PA) between T0-T1
Baseline up to 3 months
- +3 more secondary outcomes
Study Arms (2)
Arm I (Untire application)
EXPERIMENTALPatients use Untire application intervention after baseline up to 6 months.
Arm II (Untire application)
ACTIVE COMPARATORPatients use Untire application intervention after 3 months up to 6 months.
Interventions
Use Untire application after baseline up to 6 months
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Case report of diagnosis of a formal thought disorder (e.g., schizophrenia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Cobi J Heijnen
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2019
First Posted
January 18, 2019
Study Start
December 10, 2018
Primary Completion
June 20, 2019
Study Completion
June 20, 2019
Last Updated
July 29, 2020
Record last verified: 2020-07