Gastric Cancer PatientNCT06606080
The Relationship Between Time Perspective, Fear of Cancer Recurrence, Rumination, and Catastrophizing in Gastric Cancer Survivors
An observational study of Gastric Cancer Patient, run by Ting Wang at 1 site in China.
Trial summary
The temporal perspective provides a theory oriented to temporal insights that can shed light on the role of cognitive coping styles in the formation of fear of cancer recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Patient
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 10 Sep 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Select elderly gastric cancer patients who were receiving medical treatment at a tertiary hospital
Who may be able to join
- Preoperative gastroscopy and pathological diagnosis of gastric cancer;
- Aged 18 years or older
- There is no history of recurrent disease or new primary cancer
- Received surgical resection of cancerous tissues or radiotherapy treatment
- Conscious, with normal communication and comprehension ability
- The patients were aware of their own condition and diagnosis, and informedly agreed to participate in this study
Who cannot join
- ● History of mental or cognitive impairment prior to cancer diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Formation Pathway of Fear of Cancer Recurrence in Gastric Cancer Survivors From a Time Perspective
The temporal perspective provides a theory oriented to temporal insights that can shed light on the role of cognitive coping styles in the formation of fear of cancer recurrence. The self-regulatory executive function model elucidates the central role of rumination thinking, catastrophizing cognitive coping styles in the formation of cancer recurrence fear. Therefore, this study will rely on both theoretical models to construct a cognitive appraisal coping model to explore the formation pathway of cancer recurrence fear
- Conditions
- Gastric Cancer Patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Time perspective
The Chinese version of ZIPI scale was adopted for the measurement of time perspective, ZIPI scale is the current international common measurement tool.ZTPI scale was developed by Zimbardo et al. in 1999, which is mainly used for assessing individual\'s time perspective, the scale has been translated by scholars from many countries, and has good cross-cultural applicability. The Chinese version of the ZTPI scale was Chineseized and revised by Wang Chen in 2016, and the revised scale can be divided into five dimensions of past negativity (7 entries), past positivity (6 entries), present impulsivity (4 entries), future (5 entries), and present predestination (3 entries), with a total of 25 entries after exploratory factor analysis.All questions are scored on a scale of 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating a greater tendency towards certain time perspective.
Measured: through study completion, an average of 1 year
Catastrophizing
Catastrophizing was measured using the 4-item Cognitive Emotion Regulation Questionnaire Catastrophizing subscale ( CERQ-CS ). Chinese scholars such as Zhu Xiongzhao (2007) revised the Cognitive Emotion Regulation Questionnaire (CERQ) to form the Chinese version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) applicable to the Chinese version.Each item of the CERQ - CS has 5 responses ranging from 1 (almost never) to 5 (almost always). Higher total scores on this subscale indicate higher levels of catastrophizing, and this subscale has good reliability in the Chinese population, the minimum value is 4 points, and the maximum value is 20 points
Measured: through study completion, an average of 1 year
Rumination
Intrusive rumination was measured using the Event-Related Rumination Rumination Questionnaire (ERRI). It is scored according to how many rumination the subjects have produced in the last two weeks and the number of scores is used to assess the degree of rumination of the individual. It was revised by Zhou Xiao et al. (2014) to Cann et al.\'s (2010) Event-Related Rumination Questionnaire, which included two dimensions of intrusive rumination and active rumination, with a total of 20 questions. After the revision, the questionnaire had good internal consistency coefficients for the total and dimensions, and the validity indicators also reached a good level. Each item is rated on a 4 point scale, and the scores of the Intrusive rumination scales range from 0 to 30 points The higher the score, the higher the level of invasive rumination.
Measured: through study completion, an average of 1 year
Fear of cancer recurrence
The Chinese version of the Fear of Disease Progression Simplified Scale (FoP-Q-SF) was used to measure the degree of fear of recurrence in cancer patients. Our researchers and scholars, Wu Qiyun et al. translated and Chineseized the FoP-Q-SF according to Chinese characteristics to form a version of the Fear of Progression of Disease Simplified Scale suitable for cancer patients in China. There are 12 questions in total, the higher the score, the higher the level of fear of recurrence. When the score is between 12 and 23, it indicates that the patient is at a low level of fear recurrence. When the score is between 24 and 36, it indicates that the patient is at a moderate level of fear recurrence. When the score is between 36 and 60, it indicates that the patient is at a high level of fear recurrence.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start10 Aug 2023
- Primary completion1 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer PatientStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ting Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting Wang, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606080
- Sponsor's protocol ID
- 2023540
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Formation Pathway of Fear of Cancer Recurrence in Gastric Cancer Survivors From a Time Perspective
- ClinicalTrials.gov ID
- NCT06606080
- Acronym / sponsor ID
- 2023540
- Conditions
- Gastric Cancer Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Ting WangUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 20 Sep 2024 (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.
The temporal perspective provides a theory oriented to temporal insights that can shed light on the role of cognitive coping styles in the formation of fear of cancer recurrence. The self-regulatory executive function model elucidates the central role of rumination thinking, catastrophizing cognitive coping styles in the formation of cancer recurrence fear. Therefore, this study will rely on both theoretical models to construct a cognitive appraisal coping model to explore the formation pathway of cancer recurrence fear
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Select elderly gastric cancer patients who were receiving medical treatment at a tertiary hospital
Key inclusion criteria (6 listed)
- Preoperative gastroscopy and pathological diagnosis of gastric cancer;
- Aged 18 years or older
- There is no history of recurrent disease or new primary cancer
- Received surgical resection of cancerous tissues or radiotherapy treatment
- Conscious, with normal communication and comprehension ability
Key exclusion criteria (1 listed)
- ● History of mental or cognitive impairment prior to cancer diagnosis
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
Time perspective
Time frame: through study completion, an average of 1 year
The Chinese version of ZIPI scale was adopted for the measurement of time perspective, ZIPI scale is the current international common measurement tool.ZTPI scale was developed by Zimbardo et al. in 1999, which is mainly used for assessing individual\'s time perspective, the scale has been translated by scholars from many countries, and has good cross-cultural applicability. The Chinese version of the ZTPI scale was Chineseized and revised by Wang Chen in 2016, and the revised scale can be divided into five dimensions of past negativity (7 entries), past positivity (6 entries), present impulsivity (4 entries), future (5 entries), and present predestination (3 entries), with a total of 25 entries after exploratory factor analysis.All questions are scored on a scale of 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating a greater tendency towards certain time perspective.
Catastrophizing
Time frame: through study completion, an average of 1 year
Catastrophizing was measured using the 4-item Cognitive Emotion Regulation Questionnaire Catastrophizing subscale ( CERQ-CS ). Chinese scholars such as Zhu Xiongzhao (2007) revised the Cognitive Emotion Regulation Questionnaire (CERQ) to form the Chinese version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) applicable to the Chinese version.Each item of the CERQ - CS has 5 responses ranging from 1 (almost never) to 5 (almost always). Higher total scores on this subscale indicate higher levels of catastrophizing, and this subscale has good reliability in the Chinese population, the minimum value is 4 points, and the maximum value is 20 points
Rumination
Time frame: through study completion, an average of 1 year
Intrusive rumination was measured using the Event-Related Rumination Rumination Questionnaire (ERRI). It is scored according to how many rumination the subjects have produced in the last two weeks and the number of scores is used to assess the degree of rumination of the individual. It was revised by Zhou Xiao et al. (2014) to Cann et al.\'s (2010) Event-Related Rumination Questionnaire, which included two dimensions of intrusive rumination and active rumination, with a total of 20 questions. After the revision, the questionnaire had good internal consistency coefficients for the total and dimensions, and the validity indicators also reached a good level. Each item is rated on a 4 point scale, and the scores of the Intrusive rumination scales range from 0 to 30 points The higher the score, the higher the level of invasive rumination.
Fear of cancer recurrence
Time frame: through study completion, an average of 1 year
The Chinese version of the Fear of Disease Progression Simplified Scale (FoP-Q-SF) was used to measure the degree of fear of recurrence in cancer patients. Our researchers and scholars, Wu Qiyun et al. translated and Chineseized the FoP-Q-SF according to Chinese characteristics to form a version of the Fear of Progression of Disease Simplified Scale suitable for cancer patients in China. There are 12 questions in total, the higher the score, the higher the level of fear of recurrence. When the score is between 12 and 23, it indicates that the patient is at a low level of fear recurrence. When the score is between 24 and 36, it indicates that the patient is at a moderate level of fear recurrence. When the score is between 36 and 60, it indicates that the patient is at a high level of fear recurrence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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 Gastric Cancer Patient, run by Ting Wang at 1 site in China.
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 6 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: finished, as of the sponsor's last update on 20 Sep 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time perspective (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 20 Sep 2024.