Cancer SurvivorNCT03809130
Effectiveness of an Online Intervention Targeting Cancer-related Fatigue
A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Malignant Neoplasm
- What is being tested?
- Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Case report of diagnosis of a formal thought disorder (e.g., schizophrenia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cancer Survivor, Malignant Neoplasm
- Being tested
- Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Use Untire application after baseline up to 6 months
Internet-Based InterventionOther
Use Untire application after 3 months up to 6 months
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Untire application) | Experimental | Patients use Untire application intervention after baseline up to 6 months. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (Untire application) | Active comparator | Patients use Untire application intervention after 3 months up to 6 months. Receives: Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 3 months
Secondary outcomes (8)
Total days on which the patient logged in to the app
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.
Measured: Up to 6 months
Total number of activities completed on the app
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.
Measured: Up to 6 months
Total number of completed assessments on the app
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.
Measured: Up to 6 months
Change in negative affect (delta-NA) between T0-T1
The linear model described for the primary objective will be repeated.
Measured: Baseline up to 3 months
Change in positive affect (delta (PA) between T0-T1
The linear model described for the primary objective will be repeated.
Measured: Baseline up to 3 months
Change in depressive symptoms (delta-depr) between T0 and T1
The linear model described for the primary objective will be repeated.
Measured: Baseline up to 3 months
Personality traits
Personality traits and their interaction with group will be added as independent variables to the linear model described for the primary objective.
Measured: Up to 6 months
Genotypes
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start10 Dec 2018
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Why it stopped: Terminated Per PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cobi J Heijnen, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809130
- Sponsor's protocol ID
- 2018-0175
- Other IDs
- NCI-2018-02992, 2018-0175
- Status last verified
- Jul 2020
- First submitted
- 16 Jan 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
- ClinicalTrials.gov ID
- NCT03809130
- Acronym / sponsor ID
- 2018-0175
- Conditions
- Cancer Survivor, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated Per PI
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Untire application) | Experimental | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients use Untire application intervention after baseline up to 6 months. |
| Arm II (Untire application) | Active comparator | Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients use Untire application intervention after 3 months up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Case report of diagnosis of a formal thought disorder (e.g., schizophrenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionUse Untire application after baseline up to 6 months | Other | Arm I (Untire application) |
| Internet-Based InterventionUse Untire application after 3 months up to 6 months | Other | Arm II (Untire application) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (Untire application), Arm II (Untire application) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Untire application), Arm II (Untire application) |
Primary outcome
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.
8 secondary outcomes
Total days on which the patient logged in to the app
Time frame: Up to 6 months
Total number of activities completed on the app
Time frame: Up to 6 months
Total number of completed assessments on the app
Time frame: Up to 6 months
Change in negative affect (delta-NA) between T0-T1
Time frame: Baseline up to 3 months
Change in positive affect (delta (PA) between T0-T1
Time frame: Baseline up to 3 months
Change in depressive symptoms (delta-depr) between T0 and T1
Time frame: Baseline up to 3 months
Personality traits
Time frame: Up to 6 months
Genotypes
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Terminated Per PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cobi J Heijnen principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated Per PI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.