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

Primary Purpose

Stomach Cancer；Clinical Control Trial

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Marital self disclosure
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stomach Cancer；Clinical Control Trial focused on measuring Cancer Survivors；Stomach；Marital Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jingjiang people's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

marital self disclosure

Routine care

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
October 21, 2022
Last Updated
October 31, 2022
Sponsor
University of Malaya
Collaborators
Jiangsu Taizhou People's Hospital, Jingjiang People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05606549
Brief Title
Effect of MSD on FCR Among Gastric Cancer Survivors
Acronym
MSD
Official Title
Effect of Marital Self Disclosure Intervention on Fear of Cancer Recurrence and Dyadic Coping Ability Among Gastric Cancer Survivors and Their Spouse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
Collaborators
Jiangsu Taizhou People's Hospital, Jingjiang People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer；Clinical Control Trial
Keywords
Cancer Survivors；Stomach；Marital Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
marital self disclosure
Arm Type
Experimental
Arm Title
Routine care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Marital self disclosure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Patients
Description
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.
Time Frame
4 months
Title
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Dyadic Coping Inventory(DCI)
Description
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).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Ye
Phone
086-18801155781
Email
yeyecrystal@126.com
Facility Information:
Facility Name
Jingjiang people's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
214500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Ye
Phone
086-18801155781
Email
yeyecrystal@126.com

12. IPD Sharing Statement

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Effect of MSD on FCR Among Gastric Cancer Survivors

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