4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

Effectiveness of an Online Intervention Targeting Cancer-related Fatigue

Study Description
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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Malignant Neoplasm Other: Internet-Based Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 20, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Arm I (Untire application)
Patients use Untire application intervention after baseline up to 6 months.
Other: Internet-Based Intervention
Use Untire application after baseline up to 6 months

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (Untire application)
Patients use Untire application intervention after 3 months up to 6 months.
Other: Internet-Based Intervention
Use Untire application after 3 months up to 6 months

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Cobi J Heijnen M.D. Anderson Cancer Center
Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE December 10, 2018
Actual Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of an Online Intervention Targeting Cancer-related Fatigue
Official Title  ICMJE Effectiveness of a Newly Developed Online Intervention on Alleviating Cancer-Related Fatigue in Patients and Survivors
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer Survivor
  • Malignant Neoplasm
Intervention  ICMJE
  • 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
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (Untire application)
    Patients use Untire application intervention after baseline up to 6 months.
    Interventions:
    • Other: Internet-Based Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Active Comparator: Arm II (Untire application)
    Patients use Untire application intervention after 3 months up to 6 months.
    Interventions:
    • Other: Internet-Based Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 21, 2020)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
400
Actual Study Completion Date  ICMJE June 20, 2019
Actual Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809130
Other Study ID Numbers  ICMJE 2018-0175
NCI-2018-02992 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0175 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Cobi J Heijnen M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP