Comparing limited and intense follow-up care for patients with stage II-III soft tissue sarcoma
Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
This study is testing whether more frequent follow-up visits or fewer visits after surgery can help reduce anxiety and improve outcomes for patients with stage II-III soft tissue sarcoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 227 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04751409 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effects of two different follow-up approaches on anxiety levels in patients who have undergone surgery for stage II-III soft tissue sarcoma. Participants are divided into low-risk and high-risk groups, with low-risk patients receiving either intense follow-up every three months or limited follow-up every six months. The study aims to assess how these follow-up strategies impact patient anxiety, overall survival, and other cancer-related outcomes over a two-year period. By evaluating the psychological and logistical implications of surveillance frequency, the trial seeks to optimize post-operative care for sarcoma patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have completed sarcoma therapy within 8-14 weeks and are willing to participate in surveys for two years.
Not a fit: Patients with documented metastatic disease at enrollment or those who are non-English-speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health outcomes for patients by reducing anxiety associated with post-operative surveillance.
How similar studies have performed: Other studies have explored follow-up strategies in cancer care, but this specific comparison of surveillance intensity in soft tissue sarcoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
IInclusion Criteria: * ≥18 years old * Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment * Willingness to complete surveys x 2 years Exclusion Criteria: * Documented metastatic disease at the time of enrollment * Non-English-speaking patients Pregnant women will be included in this clinical trial.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Christina L Roland, MD — M.D. Anderson Cancer Center
- Study coordinator: Christina L Roland, MD
- Email: clroland@mdanderson.org
- Phone: 713-792-6940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.