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
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