- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606080
The Relationship Between Time Perspective, Fear of Cancer Recurrence, Rumination, and Catastrophizing in Gastric Cancer Survivors
September 18, 2024 updated by: Ting Wang
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
340
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 21116
- Jiangsu
-
-
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
N/A
Sampling Method
Probability Sample
Study Population
Select elderly gastric cancer patients who were receiving medical treatment at a tertiary hospital
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
● History of mental or cognitive impairment prior to cancer diagnosis
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of 1 year
|
|
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
|
through study completion, an average of 1 year
|
|
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.
|
through study completion, an average of 1 year
|
|
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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
August 10, 2023
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
September 10, 2024
Study Registration Dates
First Submitted
September 17, 2024
First Submitted That Met QC Criteria
September 18, 2024
First Posted (Actual)
September 20, 2024
Study Record Updates
Last Update Posted (Actual)
September 20, 2024
Last Update Submitted That Met QC Criteria
September 18, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Gastric Cancer Patient
-
Yonsei UniversityCompletedGastric Cancer PatientKorea, Republic of
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompleted
-
Korea University Anam HospitalKorea UniversityNot yet recruitingGastric Cancer Patients Undergoing Gastrectomy | Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy | Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy | Gastric Cancer Patient | Gastric Cancer (Diagnosis)South Korea
-
City of Hope Medical CenterCompletedGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
University of Colorado, DenverColorado State UniversityWithdrawnVirtual Reality | Diagnostic Imaging | Patient Education | Cancer PatientUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedCancer PatientUnited States
-
Istanbul Aydın UniversityCompleted
-
Danat Al Emarat HospitalNot yet recruitingGastric Ultrasound | Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks) | Gastric Ultrasound in Poorly Controlled Acute-on-chronic Pain | Gastric Ultrasound in Acute Opioid Administration Within 24 Hours Prior to the Procedure | Gastric Ultrasound in Diabetes Mellitus Without Established... and other conditionsUnited Arab Emirates
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States