Gynecologic CancerNCT05776693
Relationships Among Physical and Psychological Status, Social Support, Resource Utilization, Supportive Care Needs in Patients With Gynecological Cancer
An observational study of Gynecologic Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
With the advancement of medical treatments and under the trend of prolonging the survival rate of gynecological cancer patients, the use of social resources and the need for supportive care are particularly important! In the past, studies on patients with gynecological cancer focused on the relation between physical… Read more about this study
- Who is it for?
- Ages 20 to 100 years, women only
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Nov 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have diagnosed gynecological cancer.
Who may be able to join
- Diagnosed by a physician as a patient with gynecological cancer
- Aged 20 or above, with clear consciousness and able to communicate in Mandarin and Taiwanese.
- After reading the consent form, accept the questionnaire.
Who cannot join
- Unconscious and unable to communicate verbally to complete the interview for this study
Trial locations and contacts
1 site in 1 country.
About this study
With the advancement of medical treatments and under the trend of prolonging the survival rate of gynecological cancer patients, the use of social resources and the need for supportive care are particularly important! In the past, studies on patients with gynecological cancer focused on the relation between physical and mental symptoms, intimate relationships, social support, and quality of life. There were few studies on the relationship between social support, resource utilization, and supportive care needs for this group of patients. Therefore, this study research will be conducted on these topics. The results of the study can confirm the current situation of gynecological cancer patients using social resources and the related factors that affect their supportive care needs, and can provide important empirical data for future social resource services and international research design content.
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer, Supportive need, Social resource, Social support
What is being measured
The primary outcome is the main question the study is designed to answer.
Supportive Care Needs Survey.
Patients' supportive care needs by Supportive Care Needs Survey.It is a 5-Point Likert Scale,higher scores mean more care needs.
Measured: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Secondary outcomes (3)
Physical and Psychological Symptoms Scale
Patients' physical and psychological symptoms will be measured by Physical and Psychological Symptom Scale.It use Numerical Rating Scale(VRS)0-10.It is a 11 Point Likert Scale(e. g. 0 is no pain; 10 is unbearable pain) .
Measured: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Medical Outcomes Study Social Support Survey.
Patients' social support by Medical Outcomes Study Social Support Survey(MOS-SSS).It is a 5 Point Likert Scale(0-5) ,higher scores represents receiving more social support.
Measured: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Social resource assessment .
Patients' utilization of social resource assessment scale developed by the research team. It is a 5 Point Likert Scale(0-5).The higher the score, the more frequently the resource is used.Also answer how helpful and useful the resource is(0-10),higher scores represents more helpful and useful.
Measured: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start24 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776693
- Sponsor's protocol ID
- 202210084RINA
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Among Physical and Psychological Status, Social Support, Resource Utilization, Supportive Care Needs in Patients With Gynecological Cancer
- ClinicalTrials.gov ID
- NCT05776693
- Acronym / sponsor ID
- 202210084RINA
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer, Supportive need, Social resource, Social support
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 2023 (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.
With the advancement of medical treatments and under the trend of prolonging the survival rate of gynecological cancer patients, the use of social resources and the need for supportive care are particularly important! In the past, studies on patients with gynecological cancer focused on the relation between physical and mental symptoms, intimate relationships, social support, and quality of life. There were few studies on the relationship between social support, resource utilization, and supportive care needs for this group of patients. Therefore, this study research will be conducted on these topics. The results of the study can confirm the current situation of gynecological cancer patients using social resources and the related factors that affect their supportive care needs, and can provide important empirical data for future social resource services and international research design content.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have diagnosed gynecological cancer.
Key inclusion criteria (3 listed)
- Diagnosed by a physician as a patient with gynecological cancer
- Aged 20 or above, with clear consciousness and able to communicate in Mandarin and Taiwanese.
- After reading the consent form, accept the questionnaire.
Key exclusion criteria (1 listed)
- Unconscious and unable to communicate verbally to complete the interview for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Supportive Care Needs Survey.
Time frame: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Patients' supportive care needs by Supportive Care Needs Survey.It is a 5-Point Likert Scale,higher scores mean more care needs.
3 secondary outcomes
Physical and Psychological Symptoms Scale
Time frame: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Medical Outcomes Study Social Support Survey.
Time frame: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Social resource assessment .
Time frame: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by National Taiwan University Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supportive Care Needs Survey. (time frame: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.). 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 22 Jul 2024.