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Recruiting
NCT07227961
Activation Sarcoma: PROMIS and Mobility Evaluation in Sarcoma Patients
Conditions: Sarcoma, Giant Cell Tumor of Bone
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 800
Sponsor: University of Calgary
Location: Mayo Clinic Phoenix Arizona
Summary
Sarcoma is a rare form of bone and soft tissue cancer, making up about 1% of all adult cancers. Management typically involves radiation therapy, chemotherapy, and surgical resection. Surgery is central to the treatment of bone and soft tissue sarcoma, yet post-surgical recovery is difficult to measure because of disease rarity, multiple different tumor types, and treatment variation. Therefore, the overall goal of the study is to use patient reported outcome measures and mobility data to define recovery trajectories in sarcoma patients undergoing surgery, and to evaluate a novel smartphone application (app) entailed Activation Health for collecting these data.
Participants will download the Activation Health app on their smartphone. A demographics survey and multiple patient reported outcome measures will be administered remotely through the Activation Health app. Surveys will be completed preoperatively and at 6 weeks, 12 weeks, 6 months 12 months, 16 months, 20 months, and 24 months postoperatively. Additionally, the app will passively track mobility metrics such as daily step count, stairs climbed, and gait parameters throughout the study period. At the end of study participation, an additional surveys will be administered assess participant phone use habits and app function.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of bone sarcoma, soft tissue sarcoma, or giant cell tumor of bone
* Tumors located in the pelvis, lower extremities, or upper extremities
* Primary or recurrent disease
* Undergoing operative tumor resection, including limb salvage surgery and amputation
* Has an iPhone or Android smartphone
* Speaks English
Exclusion Criteria:
* Metastatic bone tumor
* Diagnosis of atypical lipomatous tumor
* Diagnosis of dermatofibrosarcoma protuberans
* Currently pregnant or planning pregnancy within 6 months
* Unwilling or unable to attend follow-up evaluations
* Cognitive or communication barriers that impede completion of questionnaires
Source: ClinicalTrials.gov (NCT07227961). StuddyBuddy aggregates publicly available trial information.