NCT06606080

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 17, 2024

Last Update Submit

September 18, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    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.

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Select elderly gastric cancer patients who were receiving medical treatment at a tertiary hospital

You may qualify if:

  • 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

You may not qualify if:

  • ● History of mental or cognitive impairment prior to cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu

Nanjing, Jiangsu, 21116, China

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 20, 2024

Study Start

August 10, 2023

Primary Completion

September 1, 2024

Study Completion

September 10, 2024

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations