Long TermNCT07871760
Long-Term Quality Of Life And Symptom Assessment Among Recurrence-Free Patients Who Underwent Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
An observational study of Long Term and Quality of Life, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To evaluate long-term quality of life (QoL) and participant reported symptom burden in disease-free survivors who have undergone cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) at MD Anderson, with primary emphasis on overall (composite) QoL as measured by validated instruments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term, Quality of Life, Recurrence Free
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2027to 31 Dec 2028
- 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: UT MD Anderson Cancer Center
Who may be able to join
- Males and females; age ≥18 years at the time of enrollment
- Underwent curative-intent CRS/HIPEC at MD Anderson for gastrointestinal malignancies, including colorectal cancers, appendiceal cancers, and peritoneal mesothelioma between March 1, 2016, and June 30, 2025
- Had a complete cytoreduction with a completeness of cytoreduction score (CC) of 0 or 1
- Currently alive and at least 6 months disease-free post-CRS/HIPEC, based on clinical documentation and follow-up imaging
- English-speaking
- Capable of completing an electronic survey (via REDCap)
- Provides informed consent by proceeding to survey commencement
Who cannot join
- 1. Evidence of recurrent or active malignancy at time of chart review 2. Underwent CRS/HIPEC for non-malignant conditions (e.g., multicystic mesothelioma, well-differentiated papillary mesothelioma) 3. Underwent palliative-intent surgery or had an incomplete cytoreduction (CC-2 or CC-3) 4. Did not receive HIPEC (CRS only) 5. Received HIPEC on a clinical trial 6. Significant cognitive impairment limiting ability to provide informed consent or complete the survey 7. Non-English-speaking (due to lack of validated translations for study instruments) 8. No valid contact information or no access to electronic communication (e.g., participant portal or email)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Yun Song, MD, 346-722-0041, YSong9@mdanderson.org
Yun Song, MD
About this study
To evaluate long-term quality of life (QoL) and participant reported symptom burden in disease-free survivors who have undergone cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) at MD Anderson, with primary emphasis on overall (composite) QoL as measured by validated instruments.
Read the detailed description
- To explore patterns and variability in QoL across individual instrument subscales (e.g., EORTC QLQ-C30 functional and symptom domains; HADS anxiety and depression subscales).
- To examine associations between QoL outcomes and clinical/treatment-related variables, including time since surgery.
- To identify participant-reported survivorship needs, gaps in care, and potential targets for survivorship-focused interventions (e.g., development of a survivorship clinic), with particular emphasis on qualitative responses.
- Conditions
- Long Term, Quality of Life, Recurrence Free, Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy
- Being tested
- Questionnaire and Physical Exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
All questionnaires will be complete remotely through REDCap
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start22 Mar 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long TermStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Song, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871760
- Sponsor's protocol ID
- 2026-0609
- Other IDs
- NCI-2026-07507
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Long-Term Quality Of Life And Symptom Assessment Among Recurrence-Free Patients Who Underwent Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT07871760
- Acronym / sponsor ID
- 2026-0609
- Conditions
- Long Term, Quality of Life, Recurrence Free, Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Mar 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Oct 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.
To evaluate long-term quality of life (QoL) and participant reported symptom burden in disease-free survivors who have undergone cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) at MD Anderson, with primary emphasis on overall (composite) QoL as measured by validated instruments.
Detailed description
- To explore patterns and variability in QoL across individual instrument subscales (e.g., EORTC QLQ-C30 functional and symptom domains; HADS anxiety and depression subscales).
- To examine associations between QoL outcomes and clinical/treatment-related variables, including time since surgery.
- To identify participant-reported survivorship needs, gaps in care, and potential targets for survivorship-focused interventions (e.g., development of a survivorship clinic), with particular emphasis on qualitative responses.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center
Key inclusion criteria (7 listed)
- Males and females; age ≥18 years at the time of enrollment
- Underwent curative-intent CRS/HIPEC at MD Anderson for gastrointestinal malignancies, including colorectal cancers, appendiceal cancers, and peritoneal mesothelioma between March 1, 2016, and June 30, 2025
- Had a complete cytoreduction with a completeness of cytoreduction score (CC) of 0 or 1
- Currently alive and at least 6 months disease-free post-CRS/HIPEC, based on clinical documentation and follow-up imaging
- English-speaking
Key exclusion criteria (1 listed)
- 1. Evidence of recurrent or active malignancy at time of chart review 2. Underwent CRS/HIPEC for non-malignant conditions (e.g., multicystic mesothelioma, well-differentiated papillary mesothelioma) 3. Underwent palliative-intent surgery or had an incomplete cytoreduction (CC-2 or CC-3) 4. Did not receive HIPEC (CRS only) 5. Received HIPEC on a clinical trial 6. Significant cognitive impairment limiting ability to provide informed consent or complete the survey 7. Non-English-speaking (due to lack of validated translations for study instruments) 8. No valid contact information or no access to electronic communication (e.g., participant portal or email)
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 |
|---|---|---|
| Questionnaire and Physical ExamAll questionnaires will be complete remotely through REDCap | Other | – |
Primary outcome
Quality of Life Questionnaire
Time frame: Through study completion; an average of 1 year
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 13 Oct 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Yun Song, MD principal investigator
UT MD Anderson Cancer Center
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 Long Term and Quality of Life, run by M.D. Anderson Cancer Center at 1 site in United States.
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 1 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: opening soon, 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 1 site in United States. 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?
Contact Yun Song, MD (346-722-0041, YSong9@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: Through study completion; an average of 1 year). 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.