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Clinical Trials/NCT05606549
NCT05606549
Recruiting
Not Applicable

Effect of Marital Self Disclosure Intervention on Fear of Cancer Recurrence and Dyadic Coping Ability Among Gastric Cancer Survivors and Their Spouse

University of Malaya1 site in 1 country84 target enrollmentOctober 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stomach Cancer;Clinical Control Trial
Sponsor
University of Malaya
Enrollment
84
Locations
1
Primary Endpoint
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The goal of this clinical trial is to explores the effect of marital self disclosure intervention on fear of cancer recurrence and dyadic coping ability in gastric cancer survivors and their spouses. The main questions are: What is the level of fear of cancer recurrence among gastric cancer survivors and their spouse? What is the level of dyadic coping ability among gastric cancer survivors and their spouse?What is the effect of marital self-disclosure intervention on fear of cancer recurrence and dyadic coping ability in the gastric cancer survivors and their spouses? Participants will accept the intervention of marital self disclosure for 4 times (4 cycles of chemotherapy) with different topics. Researchers will compare with control group to see if the level of fear of cancer recurrence and dyadic coping ability will be improved.

Registry
clinicaltrials.gov
Start Date
October 19, 2022
End Date
April 20, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The disease meets the diagnostic criteria of "Guidelines for Diagnosis and Treatment of Gastric Cancer"(Department of Medical Affairs, 2019), the preoperative gastroscopy and pathological diagnosis are advanced gastric cancer, and the postoperative pathological classification is type II, III or IV
  • Age ≥ 18 years
  • Able to write and oral communicate effectively by themself
  • The main caregiver is their spouse
  • Clear consciousness, no understanding barriers
  • Agree to participate in this study

Exclusion Criteria

  • History of receiving a structured psychological intervention from a psychiatrist or a psychologist
  • Cognitive disorders or psychiatric disorders (according to the DSM-V)
  • Severe visual, hearing and speech impairment
  • With previous or concurrent malignant tumors
  • With severe complications, such as gastrointestinal obstruction, perforation, etc.

Outcomes

Primary Outcomes

Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners

Time Frame: 4 months

FoP-Q-SF for Partners is developed by Zimmermann et al. (2011) based on the structure of the FoP-Q-SF scale to assess the degree of disease progression of the patient's spouse's fear of disease. FoP-Q-SF for Partners includes 12 items, adopting 5-point Likert scale, 1 point representing "never" and 5 points representing "always", with a total score ranging from 12 to 60, with higher scores indicating higher fear of their spouse's disease progression.

Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Patients

Time Frame: 4 months

The FoP-Q-SF is a one-dimensional scale constructed by on the basis of the Fear of Progression Questionnaire (FoP-Q). The FoP-Q-SF for Patients scale includes 12 items, using 5-point Likert Scale, 1 point means "never", 5 points means "always", with a total score ranging from 12 to 60, with higher scores indicating higher fear of disease progression.

Secondary Outcomes

  • Dyadic Coping Inventory(DCI)(4 months)

Study Sites (1)

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