Gastrointestinal NeoplasmsTRACE-GINCT06996483
Sleep Disturbance, Depressive Symptoms, and Subsequent Quality of Life During Adjuvant Chemotherapy for Gastrointestinal Cancer
An observational study of Gastrointestinal Neoplasms, run by Ankara Etlik City Hospital at 3 sites in Turkey (Türkiye).
Trial summary
This prospective, single-center, non-interventional observational cohort study evaluated longitudinal changes in sleep quality, depressive symptoms, and health-related quality of life among adults receiving fluoropyrimidine-based adjuvant chemotherapy for nonmetastatic gastrointestinal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 198 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 30 May 2025to 30 Sep 2026
- Phase
- Observational
- 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
Study population: The study population comprised 198 consecutive adult patients with histologically confirmed stage II-III gastric or colorectal cancer receiving standard-of-care adjuvant FOLFOX (n=102) or CAPEOX (n=96) at Ankara Etlik City Hospital, Türkiye. Participants were prospectively enrolled between May 30, 2025, and March 30, 2026. Sleep quality, depressive symptoms, and health-related quality of life were assessed at baseline, month 3, and month 6. Nutritional and anthropometric measures were recorded, and body composition was evaluated using available routine CT examinations.
Who may be able to join
- Adults aged 18 years or older.
- Histologically confirmed nonmetastatic gastric, colon, or rectal cancer.
- Pathologic stage II or III disease.
- Planned initiation of fluoropyrimidine-based adjuvant chemotherapy with FOLFOX or CAPEOX.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Ability to understand and complete the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and EORTC QLQ-C30 questionnaires.
- Provision of written informed consent.
Who cannot join
- Metastatic (stage IV) gastrointestinal cancer.
- Regular pharmacological treatment specifically prescribed for insomnia or primary sleep disorders at baseline.
- Psychiatric, neurological, or cognitive conditions that preclude reliable completion of patient-reported outcome questionnaires.
- Inability to complete study assessments because of language or communication barriers.
- Inability to participate in the scheduled longitudinal follow-up assessments.
- Pre-existing selective serotonin reuptake inhibitor (SSRI) therapy was not considered an exclusion criterion solely on the basis of medication class. Baseline SSRI use was documented and accounted for in the statistical analyses.
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06210
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, 06210
Etlik City Hospital
Ankara, Yenimahalle, 06210
About this study
This prospective, single-center, non-interventional observational cohort study evaluated longitudinal changes in sleep quality, depressive symptoms, and health-related quality of life among adults receiving fluoropyrimidine-based adjuvant chemotherapy for nonmetastatic gastrointestinal cancers.
A total of 198 participants receiving either FOLFOX or CAPEOX were enrolled at Ankara Etlik City Hospital between May 30, 2025, and March 30, 2026. Longitudinal patient-reported outcomes included the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Read more
The longitudinal assessment framework included baseline, month-3, and month-6 evaluations. In addition to describing changes in sleep, depressive symptoms, and quality of life, analyses examined the temporal indirect association between baseline sleep disturbance and month-6 global health status/quality of life through month-3 depressive symptoms.
Secondary analyses evaluated nutritional status, anthropometric measures, and body composition using clinically available computed tomography examinations. Treatment-regimen comparisons were observational and did not involve investigator-directed treatment assignment.
The final follow-up data cutoff was September 30, 2026.
Read the detailed description
This prospective, single-center observational study was conducted in the Medical Oncology Department of Ankara Etlik City Hospital, Türkiye, among adults with histologically confirmed nonmetastatic gastrointestinal malignancies who were scheduled to receive fluoropyrimidine-based adjuvant chemotherapy.
Participants received standard-of-care treatment with either FOLFOX, an intravenous fluorouracil-based regimen, or CAPEOX, an oral capecitabine-based regimen combined with intravenous oxaliplatin. Treatment allocation was determined by routine clinical care rather than research assignment.
The final cohort comprised 198 participants. Recruitment began on May 30, 2025, and ended on March 30, 2026. The longitudinal assessment schedule included baseline, month 3, and month 6, with a final follow-up data cutoff of September 30, 2026.
Sleep quality was evaluated using the PSQI, depressive symptoms using the BDI, and health-related quality of life using the EORTC QLQ-C30. The principal quality-of-life domains evaluated included global health status/quality of life, physical functioning, and fatigue.
Longitudinal analyses characterized changes in patient-reported outcomes during adjuvant chemotherapy. A longitudinal path model examined the association between baseline PSQI and month-6 global health status/quality of life through month-3 depressive symptom burden. The reciprocal temporal association was also evaluated. These models were interpreted as observational associations rather than evidence of causal mediation.
Additional analyses evaluated the relationships of baseline and longitudinal body-composition measurements with subsequent health-related quality of life. Skeletal muscle index and muscle attenuation were obtained from routine clinically available computed tomography examinations; no additional CT examinations were required solely for research purposes.
Nutritional screening, body weight, body mass index, treatment-related factors, and relevant baseline clinical characteristics were recorded. Exploratory analyses examined longitudinal differences according to chemotherapy regimen.
The study did not modify standard oncological treatment. Patients requiring additional assessment for clinically significant sleep disturbances or psychological symptoms could be referred for appropriate clinical evaluation.
The original ClinicalTrials.gov registration emphasized comparisons of oral versus intravenous fluoropyrimidine-based regimens and early PSQI/BDI assessments. Subsequent registration updates should be interpreted in conjunction with the dated ethics-approved study protocol, the actual longitudinal assessment schedule, and the publicly available registration history.
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Adjuvant Chemotherapy, 5-Fluorouracil, Sleep Quality, Depression, Gastrointestinal Cancer, Oral Chemotherapy, Intravenous Chemotherapy, Beck Depression Inventory, Pittsburgh Sleep Quality Index, sarcopenia, skeletal muscle index
- Medical subject headings
- Gastrointestinal Neoplasms, Sleep Initiation and Maintenance Disorders, Depression, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAPEOX Cohort | Patients with nonmetastatic gastrointestinal cancer receiving standard-of-care adjuvant chemotherapy with CAPEOX (oral capecitabine plus intravenous oxaliplatin). This observational cohort comprised 96 participants. Treatment selection was determined by routine clinical practice, without investigator-directed treatment assignment. | |
| FOLFOX Cohort | Patients with nonmetastatic gastrointestinal cancer receiving standard-of-care adjuvant chemotherapy with FOLFOX (intravenous fluorouracil, leucovorin, and oxaliplatin). This observational cohort comprised 102 participants. Treatment selection was determined by routine clinical practice, without investigator-directed treatment assignment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Indirect Association Between Sleep Disturbance, Depressive Symptoms, and Quality of Life
The indirect association of baseline Pittsburgh Sleep Quality Index (PSQI) score with month-6 EORTC QLQ-C30 global health status/quality-of-life score through month-3 Beck Depression Inventory (BDI) score is estimated using an adjusted longitudinal path model. The indirect association is expressed as the product of regression coefficients (a×b), with a bootstrap 95% confidence interval.
Measured: Baseline, Month 3, and Month 6 (up to 6 months after chemotherapy initiation).
Secondary outcomes (5)
Longitudinal Change in Depressive Symptoms Assessed by the Beck Depression Inventory
Depressive symptoms are assessed using the Beck Depression Inventory (BDI), with total scores ranging from 0 to 63. Higher scores indicate greater depressive symptom burden. Changes in BDI total scores are evaluated across baseline, month 3, and month 6 using longitudinal mixed-effects models.
Measured: Baseline, Month 3, and Month 6.
Longitudinal Change in EORTC QLQ-C30 Global Health Status/Quality of Life
Global health status/quality of life is assessed using the EORTC QLQ-C30 global health status scale, ranging from 0 to 100. Higher scores indicate better quality of life. Changes over time are evaluated using longitudinal mixed-effects models.
Measured: Baseline, Month 3, and Month 6.
Longitudinal Changes in Physical Functioning and Fatigue
Physical functioning and fatigue are evaluated using the corresponding EORTC QLQ-C30 scales (0-100). Higher physical-functioning scores represent better functioning, whereas higher fatigue scores indicate greater symptom burden. Longitudinal changes are assessed across three scheduled visits.
Measured: Baseline, Month 3, and Month 6.
Longitudinal Change in Skeletal Muscle Index (SMI)
Skeletal muscle index (SMI, cm²/m²) is calculated from skeletal muscle cross-sectional area at the third lumbar vertebral level (L3), measured using clinically available computed tomography (CT) images and normalized to height squared. Longitudinal changes in SMI and its associations with month-6 health-related quality of life are evaluated. No additional CT scans are performed for research purposes.
Measured: Baseline, Month 3, and Month 6 (when routine CT images are available).
Longitudinal Change in Skeletal Muscle Attenuation
Skeletal muscle attenuation is measured in Hounsfield units (HU) from L3 skeletal muscle segmentation on routine CT images. Longitudinal changes in muscle attenuation and its associations with month-6 global health status/quality of life, physical functioning, and fatigue are evaluated. Higher attenuation generally indicates lower intramuscular fat content.
Measured: Baseline, Month 3, and Month 6 (when routine CT images are available).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start30 May 2025
- Primary completion30 Mar 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Dr. Osman Sütcüoğlu, MD, Study director, Etlik City Hospital, Medical Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996483
- Sponsor's protocol ID
- AESH-EK1-2023-775
- Acronym
- TRACE-GI
- Status last verified
- Oct 2026
- First submitted
- 21 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to local data protection regulations, ethical restrictions, and the absence of prior consent for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance, Depressive Symptoms, and Subsequent Quality of Life During Adjuvant Chemotherapy for Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT06996483
- Acronym / sponsor ID
- TRACE-GI / AESH-EK1-2023-775
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Adjuvant Chemotherapy, 5-Fluorouracil, Sleep Quality, Depression, Gastrointestinal Cancer, Oral Chemotherapy, Intravenous Chemotherapy, Beck Depression Inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 30 May 2025 (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, single-center, non-interventional observational cohort study evaluated longitudinal changes in sleep quality, depressive symptoms, and health-related quality of life among adults receiving fluoropyrimidine-based adjuvant chemotherapy for nonmetastatic gastrointestinal cancers.
A total of 198 participants receiving either FOLFOX or CAPEOX were enrolled at Ankara Etlik City Hospital between May 30, 2025, and March 30, 2026. Longitudinal patient-reported outcomes included the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
The longitudinal assessment framework included baseline, month-3, and month-6 evaluations. In addition to describing changes in sleep, depressive symptoms, and quality of life, analyses examined the temporal indirect association between baseline sleep disturbance and month-6 global health status/quality of life through month-3 depressive symptoms.
Secondary analyses evaluated nutritional status, anthropometric measures, and body composition using clinically available computed tomography examinations. Treatment-regimen comparisons were observational and did not involve investigator-directed treatment assignment.
The final follow-up data cutoff was September 30, 2026.
Detailed description
This prospective, single-center observational study was conducted in the Medical Oncology Department of Ankara Etlik City Hospital, Türkiye, among adults with histologically confirmed nonmetastatic gastrointestinal malignancies who were scheduled to receive fluoropyrimidine-based adjuvant chemotherapy.
Participants received standard-of-care treatment with either FOLFOX, an intravenous fluorouracil-based regimen, or CAPEOX, an oral capecitabine-based regimen combined with intravenous oxaliplatin. Treatment allocation was determined by routine clinical care rather than research assignment.
The final cohort comprised 198 participants. Recruitment began on May 30, 2025, and ended on March 30, 2026. The longitudinal assessment schedule included baseline, month 3, and month 6, with a final follow-up data cutoff of September 30, 2026.
Sleep quality was evaluated using the PSQI, depressive symptoms using the BDI, and health-related quality of life using the EORTC QLQ-C30. The principal quality-of-life domains evaluated included global health status/quality of life, physical functioning, and fatigue.
Longitudinal analyses characterized changes in patient-reported outcomes during adjuvant chemotherapy. A longitudinal path model examined the association between baseline PSQI and month-6 global health status/quality of life through month-3 depressive symptom burden. The reciprocal temporal association was also evaluated. These models were interpreted as observational associations rather than evidence of causal mediation.
Additional analyses evaluated the relationships of baseline and longitudinal body-composition measurements with subsequent health-related quality of life. Skeletal muscle index and muscle attenuation were obtained from routine clinically available computed tomography examinations; no additional CT examinations were required solely for research purposes.
Nutritional screening, body weight, body mass index, treatment-related factors, and relevant baseline clinical characteristics were recorded. Exploratory analyses examined longitudinal differences according to chemotherapy regimen.
The study did not modify standard oncological treatment. Patients requiring additional assessment for clinically significant sleep disturbances or psychological symptoms could be referred for appropriate clinical evaluation.
The original ClinicalTrials.gov registration emphasized comparisons of oral versus intravenous fluoropyrimidine-based regimens and early PSQI/BDI assessments. Subsequent registration updates should be interpreted in conjunction with the dated ethics-approved study protocol, the actual longitudinal assessment schedule, and the publicly available registration history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAPEOX Cohort | – | –Patients with nonmetastatic gastrointestinal cancer receiving standard-of-care adjuvant chemotherapy with CAPEOX (oral capecitabine plus intravenous oxaliplatin). This observational cohort comprised 96 participants. Treatment selection was determined by routine clinical practice, without investigator-directed treatment assignment. |
| FOLFOX Cohort | – | –Patients with nonmetastatic gastrointestinal cancer receiving standard-of-care adjuvant chemotherapy with FOLFOX (intravenous fluorouracil, leucovorin, and oxaliplatin). This observational cohort comprised 102 participants. Treatment selection was determined by routine clinical practice, without investigator-directed treatment assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised 198 consecutive adult patients with histologically confirmed stage II-III gastric or colorectal cancer receiving standard-of-care adjuvant FOLFOX (n=102) or CAPEOX (n=96) at Ankara Etlik City Hospital, Türkiye. Participants were prospectively enrolled between May 30, 2025, and March 30, 2026. Sleep quality, depressive symptoms, and health-related quality of life were assessed at baseline, month 3, and month 6. Nutritional and anthropometric measures were recorded, and body composition was evaluated using available routine CT examinations.
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Histologically confirmed nonmetastatic gastric, colon, or rectal cancer.
- Pathologic stage II or III disease.
- Planned initiation of fluoropyrimidine-based adjuvant chemotherapy with FOLFOX or CAPEOX.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (6 listed)
- Metastatic (stage IV) gastrointestinal cancer.
- Regular pharmacological treatment specifically prescribed for insomnia or primary sleep disorders at baseline.
- Psychiatric, neurological, or cognitive conditions that preclude reliable completion of patient-reported outcome questionnaires.
- Inability to complete study assessments because of language or communication barriers.
- Inability to participate in the scheduled longitudinal follow-up assessments.
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
Longitudinal Indirect Association Between Sleep Disturbance, Depressive Symptoms, and Quality of Life
Time frame: Baseline, Month 3, and Month 6 (up to 6 months after chemotherapy initiation).
The indirect association of baseline Pittsburgh Sleep Quality Index (PSQI) score with month-6 EORTC QLQ-C30 global health status/quality-of-life score through month-3 Beck Depression Inventory (BDI) score is estimated using an adjusted longitudinal path model. The indirect association is expressed as the product of regression coefficients (a×b), with a bootstrap 95% confidence interval.
5 secondary outcomes
Longitudinal Change in Depressive Symptoms Assessed by the Beck Depression Inventory
Time frame: Baseline, Month 3, and Month 6.
Longitudinal Change in EORTC QLQ-C30 Global Health Status/Quality of Life
Time frame: Baseline, Month 3, and Month 6.
Longitudinal Changes in Physical Functioning and Fatigue
Time frame: Baseline, Month 3, and Month 6.
Longitudinal Change in Skeletal Muscle Index (SMI)
Time frame: Baseline, Month 3, and Month 6 (when routine CT images are available).
Longitudinal Change in Skeletal Muscle Attenuation
Time frame: Baseline, Month 3, and Month 6 (when routine CT images are available).
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 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to local data protection regulations, ethical restrictions, and the absence of prior consent for data sharing.
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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.
Dr. Osman Sütcüoğlu, MD study director
Etlik City Hospital, Medical Oncology Department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasms, run by Ankara Etlik City Hospital at 3 sites in Turkey (Türkiye).
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 7 inclusion and 6 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
Longitudinal Indirect Association Between Sleep Disturbance, Depressive Symptoms, and Quality of Life (time frame: Baseline, Month 3, and Month 6 (up to 6 months after chemotherapy initiation).). 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 13 Oct 2026.