Psychological DistressNCT07924189
Association of Psychological Distress With Clinical Outcomes in Patients With Digestive System Cancers
An observational study of Psychological Distress and Pancreatic Cancer, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This prospective observational cohort study aims to investigate the association between psychological distress and clinical outcomes in patients with digestive system cancers, including pancreatic, gastric, and colorectal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Pancreatic Cancer, Colorectal Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will consist of approximately 100 adult patients with pathologically confirmed pancreatic, gastric, or colorectal cancer who are scheduled to receive first-line systemic anticancer therapy at the Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. Eligible patients will be consecutively enrolled according to the predefined inclusion and exclusion criteria. Psychological distress will be assessed at baseline and during follow-up to investigate its association with clinical outcomes, including progression-free survival and overall survival.
Who may be able to join
- Patients with pathologically confirmed digestive system cancers, including pancreatic cancer, gastric cancer, or colorectal cancer.
- Male or female patients aged 18 years or older.
- Patients scheduled to receive first-line systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or combination therapy, with no systemic treatment for the current cancer lesions within 3 months prior to enrollment.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Life expectancy of at least 12 weeks, as assessed by the investigator.
- Willing and able to provide written informed consent to participate in the study.
Who cannot join
- History of another malignancy within the past 3 years or concurrent malignancy.
- Presence of acute or chronic psychiatric disorders, or current treatment with antidepressant or anxiolytic medications.
- Previous treatment in another investigational drug trial.
- Inability to complete psychological assessment questionnaires due to cognitive impairment, language barriers, or other conditions that interfere with questionnaire completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Psychological Distress With Clinical Outcomes in Patients With Digestive System Cancers: A Prospective Cohort Study
This prospective observational cohort study aims to investigate the association between psychological distress and clinical outcomes in patients with digestive system cancers, including pancreatic, gastric, and colorectal cancers.
Approximately 100 adult patients who are scheduled to receive first-line systemic anticancer therapy will be enrolled at Xuanwu Hospital, Capital Medical University. Psychological distress will be assessed using the Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and 12-item General Health Questionnaire (GHQ-12).
Read more
Participants will undergo baseline assessments and follow-up evaluations every three months for up to three years. Clinical information, psychological distress scores, laboratory findings, imaging results, and quality-of-life data will be collected.
The primary outcome is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), and quality of life. The study will evaluate whether psychological distress is associated with cancer prognosis after adjusting for potential confounding factors, including cancer stage, treatment regimen, and nutritional status.
As an observational study, no experimental treatment will be assigned, and all participants will receive standard anticancer treatment according to routine clinical practice.
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from study enrollment to the first radiologically confirmed disease progression, as assessed by the investigator according to RECIST version 1.1, or death from any cause, whichever occurs first. PFS will be compared between patients with high and low levels of psychological distress.
Measured: From enrollment to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 May 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyan Li, MD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924189
- Sponsor's protocol ID
- hongyanli3
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Psychological Distress With Clinical Outcomes in Patients With Digestive System Cancers: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07924189
- Acronym / sponsor ID
- hongyanli3
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 9 Nov 2026 (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.
This prospective observational cohort study aims to investigate the association between psychological distress and clinical outcomes in patients with digestive system cancers, including pancreatic, gastric, and colorectal cancers.
Approximately 100 adult patients who are scheduled to receive first-line systemic anticancer therapy will be enrolled at Xuanwu Hospital, Capital Medical University. Psychological distress will be assessed using the Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and 12-item General Health Questionnaire (GHQ-12).
Participants will undergo baseline assessments and follow-up evaluations every three months for up to three years. Clinical information, psychological distress scores, laboratory findings, imaging results, and quality-of-life data will be collected.
The primary outcome is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), and quality of life. The study will evaluate whether psychological distress is associated with cancer prognosis after adjusting for potential confounding factors, including cancer stage, treatment regimen, and nutritional status.
As an observational study, no experimental treatment will be assigned, and all participants will receive standard anticancer treatment according to routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of approximately 100 adult patients with pathologically confirmed pancreatic, gastric, or colorectal cancer who are scheduled to receive first-line systemic anticancer therapy at the Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. Eligible patients will be consecutively enrolled according to the predefined inclusion and exclusion criteria. Psychological distress will be assessed at baseline and during follow-up to investigate its association with clinical outcomes, including progression-free survival and overall survival.
Key inclusion criteria (6 listed)
- Patients with pathologically confirmed digestive system cancers, including pancreatic cancer, gastric cancer, or colorectal cancer.
- Male or female patients aged 18 years or older.
- Patients scheduled to receive first-line systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or combination therapy, with no systemic treatment for the current cancer lesions within 3 months prior to enrollment.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Life expectancy of at least 12 weeks, as assessed by the investigator.
Key exclusion criteria (4 listed)
- History of another malignancy within the past 3 years or concurrent malignancy.
- Presence of acute or chronic psychiatric disorders, or current treatment with antidepressant or anxiolytic medications.
- Previous treatment in another investigational drug trial.
- Inability to complete psychological assessment questionnaires due to cognitive impairment, language barriers, or other conditions that interfere with questionnaire completion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
Time frame: From enrollment to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years.
Progression-free survival (PFS) is defined as the time from study enrollment to the first radiologically confirmed disease progression, as assessed by the investigator according to RECIST version 1.1, or death from any cause, whichever occurs first. PFS will be compared between patients with high and low levels of psychological distress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Psychological Distress and Pancreatic Cancer, run by Xuanwu Hospital, Beijing 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 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Progression-Free Survival (PFS) (time frame: From enrollment to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years.). 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 9 Nov 2026; AzTrials last refreshed its copy on 9 Nov 2026.