Gynecological CancerNCT06948305
Evaluate the Effectiveness of the Mobile Instant Messaging Intervention
A study testing instant messaging software in people with Gynecological Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Cancer
- What is being tested?
- instant messaging software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Shin Kong Memorial Wu Ho-Su Hospital
Taipei, 111
Ya-Hui Tseng, PhD, 886-2-2822-7101 Ext. 3196, yhtseng@ntunhs.edu.tw
About this study
Official title: 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.
- Conditions
- Gynecological Cancer
- Being tested
- instant messaging software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instant messaging softwareBehavioural
instant messaging software
| Study group | Role | What they receive |
|---|---|---|
| instant messaging software | Experimental | Not described Receives: Behavioral: instant messaging software |
| "Control Group" | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supportive Care Needs -Partners & Caregivers 45, SCNS-P&C45
Measured: Post-intervention assessments will be conducted at 1 month, 3 months, and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Ru Lin, PhD, RN, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948305
- Sponsor's protocol ID
- NTUNHS-2025-04
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Care Needs of Spouses of Gynecological Cancer Patients and Evaluating the Development of Care Plans
- ClinicalTrials.gov ID
- NCT06948305
- Acronym / sponsor ID
- NTUNHS-2025-04
- Conditions
- Gynecological Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| instant messaging software | Experimental | Behavioral: instant messaging software |
| "Control Group" | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals with psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instant messaging softwareinstant messaging software | Behavioural | instant messaging software |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instant messaging software in people with Gynecological Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung-Ru Lin, PhD (886-2-2822-7101 Ext. 3197, hungru@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.