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Trial Title:
Effect of MSD on FCR Among Gastric Cancer Survivors
NCT ID:
NCT05606549
Condition:
Stomach Cancer；Clinical Control Trial
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Cancer Survivors；Stomach；Marital Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Marital self disclosure
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.
Arm group label:
marital self disclosure
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jingjiang people's Hospital
Address:
City:
Taizhou
Zip:
214500
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Ye
Phone:
086-18801155781
Email:
yeyecrystal@126.com
Start date:
October 19, 2022
Completion date:
April 20, 2024
Lead sponsor:
Agency:
University of Malaya
Agency class:
Other
Collaborator:
Agency:
Jiangsu Taizhou People's Hospital
Agency class:
Other
Collaborator:
Agency:
Jingjiang People's Hospital
Agency class:
Other
Source:
University of Malaya
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05606549
