Evaluate the Effectiveness of the Mobile Instant Messaging Intervention

April 28, 2025 updated by: Hung-Ru Lin, PhD, RN, National Taipei University of Nursing and Health Sciences

Exploring the Care Needs of Spouses of Gynecological Cancer Patients and Evaluating the Development of Care Plans

This study explores the caregiving needs of male spouses and develops an instant messaging software intervention to provide effective support. The goal is to help male spouses better adjust to their caregiving roles, reduce psychological stress and emotional distress, and improve overall health.

A randomized controlled trial will be conducted to evaluate the effectiveness of the mobile instant messaging intervention, analyzing its impact on reducing psychological distress and improving the quality of life of male spouses.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 111
        • Shin Kong Memorial Wu Ho-Su Hospital
        • Contact:

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

Yes

Description

Inclusion Criteria:

  1. Age 18 or older, with a diagnosis of gynecological cancer (including cancers of the cervix, endometrium, fallopian tubes, ovaries, uterus, or vagina), and whose spouse has not been diagnosed with any other type of cancer;
  2. The spouse has undergone cancer treatment, including surgery, chemotherapy, or radiotherapy;
  3. Clear consciousness and ability to communicate in Mandarin or Taiwanese;
  4. Willingness to participate in the study after being informed of the study purpose and procedures.

Exclusion Criteria:

Individuals with psychiatric disorders.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: instant messaging software
Behavioral: instant messaging software
instant messaging software
No Intervention: "Control Group"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Supportive Care Needs -Partners & Caregivers 45, SCNS-P&C45
Time Frame: Post-intervention assessments will be conducted at 1 month, 3 months, and 6 months after the intervention.
Post-intervention assessments will be conducted at 1 month, 3 months, and 6 months after the intervention.

Collaborators and Investigators

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

Sponsor

National Taipei University of Nursing and Health Sciences

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)

August 1, 2025

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • NTUNHS-2025-04

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.

Subscribe