Effect of MSD on FCR Among Gastric Cancer Survivors (MSD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Cancer；Clinical Control Trial
• Intervention / Treatment: Behavioral: Marital self disclosure

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhou Ye; Phone Number: 086-18801155781; Email: yeyecrystal@126.com

Study Locations

• China
  • Jiangsu
    • Taizhou, Jiangsu, China, 214500
      • Recruiting
      • Jingjiang People's Hospital
      • Contact: Zhou Ye; Phone Number: 086-18801155781; Email: yeyecrystal@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: marital self disclosure	Behavioral: Marital self disclosure; Intervention time during hospitalization is the first day after chemotherapy, and intervene once per chemotherapy, a total of 4 times, 40-60 min each time. Interventions included verbal and written disclosure. The researcher will preside over the MSD process and introduce of MSD for gastric patients and their spouse，both patient and their spouse will receive a training or review on MSD skills, 5-10 minutes each time. Couples practice MSD skills through 4 revealing themes. Couples are encouraged to express their FCR, and when one partner disclosure, supporters should allow the speaker to fully express their feelings and respond positively to the speaker's message, showing empathy for them, and acknowledging their point of view.
No Intervention: Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Patients	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.	4 months
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyadic Coping Inventory(DCI)	DCI based on the system interaction model was originally developed by Bodenmann ( 2000), which includes 6 dimensions, 55 items, and use Likert 5-point scale. After further improvement, the DCI (Bodenmann & Randall, 2012) was revised to 37 items and measured on a 5-point Likert scale, ranging from 1 (not at all/very rarely) to 5 (very often).	4 months

Collaborators and Investigators

• Sponsor: University of Malaya
• Collaborators: Jiangsu Taizhou People's Hospital; Jingjiang People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Anticipated): October 25, 2023
• Study Completion (Anticipated): April 20, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cancer Survivors；Stomach；Marital Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 18801155781

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No