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

May 27, 2023 updated by: Erna Rochmawati, Universitas Muhammadiyah Yogyakarta
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with cancer with comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile health self-management
Behavioral: Mobile-health self management
Mobile-health self management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four weeks
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.
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Muhammadiyah Yogyakarta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 27, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 27, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Manner and QOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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