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Personalized Acceptance-Based Mindfulness Exercise Intervention before Surgery in Musculoskeletal Tumor Patients

Trial Status: Active

This trial studies how well an interactive personalized acceptance-based mindfulness exercise works in improving anxiety in musculoskeletal tumor patients who are undergoing surgery. Participating in the 60-second mindfulness-based exercise before surgery may improve patients' ratings of anxiety and pain, distress, depression and anger.

Inclusion Criteria

  • Patients with a musculoskeletal malignancy undergoing curative surgical treatment
  • Histologic confirmation of malignancy prior to curative surgery
  • Primary surgery of musculoskeletal malignancy at the Massachusetts General Hospital
  • Able to give informed consent
  • English fluency and literacy * English fluency is needed because the intervention (a 60-seconds video) is in English and there is no alternate version available

Exclusion Criteria

  • Significant axis I or II psychopathology that would interfere with participation in the study
  • Pregnant patients
  • Metastasis at presentation

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Ana-Maria Vranceanu
Phone: 617-724-4977

PRIMARY OBJECTIVE:

I. To evaluate the effect of a preoperative 60-second interactive personalized acceptance-based mindfulness exercise (intervention) versus a brief educational pamphlet (control) on anxiety in patients undergoing curative surgery for a musculoskeletal malignancy.

SECONDARY OBJECTIVE:

I. The effect of the intervention on pain intensity, depression, distress and anger along with patient compliance of the home-use of a mindfulness intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (MINDFULNESS EXERCISE): Prior to surgery, patients write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame daily up to 1-2 days prior to admission for surgery.

GROUP II (EDUCATIONAL PAMPHLET): Prior to surgery, patients read educational pamphlet on pain and stress over 60 seconds daily up to 1-2 days prior to admission for surgery.

Trial Phase Phase NA

Trial Type Supportive care

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Ana-Maria Vranceanu

  • Primary ID 19-097
  • Secondary IDs NCI-2019-08121
  • Clinicaltrials.gov ID NCT04143529