Colorectal CancerNCT05845294
A Study of the Effect of Short-term Structured Psychological Care in Patients
A study testing Routine Care and Short-term structured psychological Care in people with Colorectal Cancer, run by Zunyi Medical College at 1 site in China.
Trial summary
The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Routine Care and Short-term structured psychological Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Dec 2020
- 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
- voluntary participation in the study and ability to cooperate with treatment and care;
- patients who were to undergo enterostomy;
- age ≥18 years;
- consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);
- social impact scale (SIS) score ≥24.
Who cannot join
- Critically ill and unable to cooperate with the study;
- Impaired cognitive function that affects communication;
- Patients with other organic diseases in combination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer
The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.
- Conditions
- Colorectal Cancer
- Being tested
- Routine Care, Short-term structured psychological Care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareProcedure or surgery
Routine care for patients undergoing colorectal cancer stoma
Short-term structured psychological CareProcedure or surgery
Short-term structured psychological care for colorectal cancer stoma patients based on conventional care
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Procedure: Routine Care |
| Experimental group | Experimental | Not described Receives: Procedure: Short-term structured psychological Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Measured: 1 month
Anxiety of patients was assessed by the Social Impact Scale
Anxiety of patients was assessed by the Social Impact Scale
Measured: 1 month
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Ren, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845294
- Sponsor's protocol ID
- Zunyi002
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05845294
- Acronym / sponsor ID
- Zunyi002
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 6 May 2023 (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 study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Routine Care |
| Experimental group | Experimental | Procedure: Short-term structured psychological Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- voluntary participation in the study and ability to cooperate with treatment and care;
- patients who were to undergo enterostomy;
- age ≥18 years;
- consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);
- social impact scale (SIS) score ≥24.
Key exclusion criteria (3 listed)
- Critically ill and unable to cooperate with the study;
- Impaired cognitive function that affects communication;
- Patients with other organic diseases in combination.
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 |
|---|---|---|
| Routine CareRoutine care for patients undergoing colorectal cancer stoma | Procedure or surgery | Control group |
| Short-term structured psychological CareShort-term structured psychological care for colorectal cancer stoma patients based on conventional care | Procedure or surgery | Experimental group |
Primary outcome
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Time frame: 1 month
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Anxiety of patients was assessed by the Social Impact Scale
Time frame: 1 month
Anxiety of patients was assessed by the Social Impact Scale
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Time frame: 1 month
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care and Short-term structured psychological Care in people with Colorectal Cancer, run by Zunyi Medical College 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 6 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.