Patient-reported Outcomes Following Percutaneous Ablation of Desmoid Tumors

N/AEnrolling By InvitationNCT07755176

Mayo Clinic30 enrolled

Overview

This study will evaluate patient-reported outcomes before and after percutaneous ablation of desmoid tumors. Adult participants undergoing ablation for desmoid tumor will complete surveys pre and post procedure to assess symptom burden, impact on daily life, early post-procedural pain and recovery, concomitant treatments, and radiological response following ablation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Desmoid Tumor Aggressive Fibromatoses

Interventions

Desmoid tumor ablationPROCEDURE

Percutaneous ablation of desmoid tumor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients undergoing ablation for desmoid tumor. Exclusion Criteria: * Declines to participate in research.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in desmoid tumor symptom severity following ablation

Desmoid tumor symptom severity following ablation will be measured using the GODDESS© Desmoid Tumor Symptom Scale, a disease-specific patient-reported outcome measure assessing desmoid tumor-related symptoms. Scores will be calculated according to the validated GODDESS© scoring algorithm. Higher scores indicate greater symptom burden.

Time frame: Baseline; 7 days; 1, 3, 6, 12, and 24 months post-ablation

Change in desmoid tumor impact following ablation

Desmoid tumor impact following ablation will be measured using the GODDESS© Desmoid Impact Scale, a disease-specific patient-reported outcome measure assessing desmoid tumor-related symptoms on patients' daily lives and functioning. Scores will be calculated according to the validated GODDESS© scoring algorithm. Higher scores are expected to indicate greater disease-related impact.

Time frame: Baseline; 7 days; 1, 3, 6, 12, and 24 months post-ablation

Change in post-procedural pain score

The pain score is calculated from a 2 question self-report survey asking recipients to rate pain on a scale of 1-10. Higher scores indicate worse pain.

Time frame: Baseline; 7 days; 1 month and 3 months post-ablation

Secondary Outcomes

Radiological response following ablation

Radiologic assessment of desmoid tumor response on follow-up imaging, including tumor response characteristics as available in the medical record.

Time frame: Through 24 months post-ablation

Data from ClinicalTrials.gov

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