Effect of MSD on FCR Among Gastric Cancer Survivors

NCT05606549 | Unknown DMC

• 1 other identifier: 18801155781
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Cancer；Clinical Control Trial

Keywords

Cancer Survivors；Stomach；Marital Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Dyadic Coping Inventory(DCI)

  4 months

Study Arms (2)

marital self disclosure

EXPERIMENTAL

Behavioral: Marital self disclosure

Routine care

NO INTERVENTION

Interventions

Marital self disclosure BEHAVIORAL

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.

marital self disclosure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead
• Jiangsu Taizhou People's Hospital: collaborator
• Jingjiang People's Hospital: collaborator

Study Sites (1)

Jingjiang people's Hospital

Taizhou, Jiangsu, 214500, China

RECRUITING

Related Publications (1)

• Zhao H, Zhou Y, Che CC, Chong MC, Zheng Y, Hou Y, Chen C, Zhu Y. Marital Self-Disclosure Intervention for the Fear of Cancer Recurrence in Chinese Patients With Gastric Cancer: Protocol for a Quasiexperimental Study. JMIR Res Protoc. 2024 Apr 29;13:e55102. doi: 10.2196/55102.

  PMID: 38684089 DERIVED

Central Study Contacts

Zhou Ye

CONTACT

086-18801155781; yeyecrystal@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 4, 2022
• Study Start: October 19, 2022
• Primary Completion: October 25, 2023
• Study Completion: April 20, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-10

Locations

CN (1)