NCT06948305

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Jul 2028

First Submitted

Initial submission to the registry

April 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

April 21, 2025

Last Update Submit

April 28, 2025

Conditions

Gynecological Cancer

Outcome Measures

Primary Outcomes (1)

  • Supportive Care Needs -Partners & Caregivers 45, SCNS-P&C45

    Post-intervention assessments will be conducted at 1 month, 3 months, and 6 months after the intervention.

Study Arms (2)

instant messaging software

EXPERIMENTAL
Behavioral: instant messaging software

"Control Group"

NO INTERVENTION

Interventions

instant messaging softwareBEHAVIORAL

instant messaging software

instant messaging software

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • The spouse has undergone cancer treatment, including surgery, chemotherapy, or radiotherapy;
  • Clear consciousness and ability to communicate in Mandarin or Taiwanese;
  • Willingness to participate in the study after being informed of the study purpose and procedures.

You may not qualify if:

  • Individuals with psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Memorial Wu Ho-Su Hospital

Taipei, 111, Taiwan

Location

Central Study Contacts

Hung-Ru Lin, PhD

CONTACT

886-2-2822-7101 Ext. 3197hungru@ntunhs.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor & Dean, College of Nursing

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 29, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

TW(1)