A Study to Evaluate Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-002674
NCT ID: NCT05526417
Sponsor Protocol Number: GMROA2182
About this study
The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Histologically or cytologically-proven deep STS of the lower extremity.
- Localized.
- Adults, 18 and older.
- All gender types.
- Subjects must be able to provide appropriate consent or have an appropriate representative available to do so.
Exclusion Criteria:
- Soft tissue sarcomas that are in a superficial location relative to fascia.
- Patients with metastatic disease (distant or nodal).
- Both and upper and lower extremity involvement.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Krista Goulding, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available