Effectiveness of an Online Intervention Targeting Cancer-related Fatigue
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | December 10, 2018 |
| End Date: | January 31, 2021 |
| Contact: | Cobi J Heijnen |
| Email: | cjheijnen@mdanderson.org |
| Phone: | 713-745-3470 |
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.
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.
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.
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.
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)
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Cobi J. Heijnen
Phone: 713-745-3470
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