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Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy (MANNER)

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ClinicalTrials.gov Identifier: NCT05881070
Recruitment Status : Not yet recruiting
First Posted : May 29, 2023
Last Update Posted : May 29, 2023
Sponsor:
Information provided by (Responsible Party):
Erna Rochmawati, Universitas Muhammadiyah Yogyakarta

Tracking Information
First Submitted Date  ICMJE May 8, 2023
First Posted Date  ICMJE May 29, 2023
Last Update Posted Date May 29, 2023
Estimated Study Start Date  ICMJE June 15, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2023)
  • Patient's Quality of life [ Time Frame: Four weeks ]
    The patient's quality of life will be assessed before (T0) and after intervention (T1). The measurement will use EORTC. The score will range from 0-100, where higher score reflects a better quality of life.
  • Patient's Self-efficacy [ Time Frame: four weeks ]
    The patients self-efficacy will be measured pre and post intervention. The measurement will use the Self-Efficacy for Managing Chronic Disease Scale. The scale has been widely used in cancer setting. Respondents will rate their confidence to perform six self-management behaviours (1 = 'not at all confident' to 10 = 'totally confident'). A mean score is calculated (range 1 to 10). A high score indicates high self-efficacy.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy
Official Title  ICMJE Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy
Brief Summary The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.
Detailed Description The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Chemotherapy Effect
  • Quality of Life
  • Self Efficacy
Intervention  ICMJE Behavioral: Mobile-health self management
Mobile-health self management
Study Arms  ICMJE Experimental: Mobile health self-management
Intervention: Behavioral: Mobile-health self management
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2023)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients diagnosed with cancer
  • patients who use smart phone

Exclusion Criteria:

  • patients with cancer with comorbidity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05881070
Other Study ID Numbers  ICMJE Manner and QOL
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: Undecided
Current Responsible Party Erna Rochmawati, Universitas Muhammadiyah Yogyakarta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universitas Muhammadiyah Yogyakarta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitas Muhammadiyah Yogyakarta
Verification Date May 2023

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