Stomach Cancer；Clinical Control TrialMSDNCT05606549
Effect of MSD on FCR Among Gastric Cancer Survivors
A study testing Marital self disclosure in people with Stomach Cancer；Clinical Control Trial, run by University of Malaya at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer；Clinical Control Trial
- What is being tested?
- Marital self disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2022to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jingjiang people's Hospital
Taizhou, Jiangsu, 214500
Zhou Ye, 086-18801155781, yeyecrystal@126.com
About this study
Official title: 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.
- Conditions
- Stomach Cancer；Clinical Control Trial
- Being tested
- Marital self disclosure
- Keywords
- Cancer Survivors；Stomach；Marital Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marital self disclosureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| marital self disclosure | Experimental | Not described Receives: Behavioral: Marital self disclosure |
| Routine care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Secondary outcomes (1)
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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start19 Oct 2022
- Primary completion25 Oct 2023 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach Cancer；Clinical Control TrialStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Taizhou People's Hospital, Jingjiang People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606549
- Sponsor's protocol ID
- 18801155781
- Acronym
- MSD
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38684089
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Marital Self Disclosure Intervention on Fear of Cancer Recurrence and Dyadic Coping Ability Among Gastric Cancer Survivors and Their Spouse
- ClinicalTrials.gov ID
- NCT05606549
- Acronym / sponsor ID
- MSD / 18801155781
- Conditions
- Stomach Cancer；Clinical Control Trial
- Keywords
- Cancer Survivors；Stomach；Marital Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Jiangsu Taizhou People's Hospital, Jingjiang People's Hospital
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| marital self disclosure | Experimental | Behavioral: Marital self disclosure |
| Routine care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marital self disclosureIntervention 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. | Behavioural | marital self disclosure |
Primary outcome
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.
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.
1 secondary outcome
Dyadic Coping Inventory(DCI)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 38684089Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marital self disclosure in people with Stomach Cancer；Clinical Control Trial, run by University of Malaya at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Ye (086-18801155781, yeyecrystal@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Patients (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.