Preoperative Mindfulness in Musculoskeletal Tumor Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Musculoskeletal Malignancy
- Sponsor
- Massachusetts General Hospital
- Locations
- 1
- Primary Endpoint
- Difference in State Trait Anxiety Score between Groups
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
Psychosocial distress is common in patients with an oncologic diagnosis, with anxiety being present in almost 20-30% of the patients.[1, 2, 10] Mindfulness exercises have shown to reduce this distress.[4, 5]
Recently, the implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity patients.[9] However, its lasting effect after the single intervention was not evaluated. Nonetheless, because the intervention is not time consuming and is easy to implement it may benefit orthopaedic oncology patients in their pre-operative coping.
The implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity participants. In this research study, the investigators are studying a 60-second interactive personalized acceptance-based mindfulness exercise
Detailed Description
The aim of this study is 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.
Investigators
Ana-Maria Vranceanu, PhD
Prinicipal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •All adult (\>18 years) patients attending the Orthopaedic Oncology Department outpatient clinic (Dr. Santiago Lozano-Calderon, Dr. Kevin Raskin, Dr. J. Schwab) at the MGH with a histologically confirmed musculoskeletal malignancy undergoing curative surgery will be enrolled at their last preoperative visit.
- •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.
- •Age ≥18 years
- •Exclusion criteria:
- •Significant axis I or II psychopathology that would interfere with participation in the study
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Difference in State Trait Anxiety Score between Groups
Time Frame: from enrollment to the day of admission for surgery up to 3 weeks
State-Trait Anxiety Inventory (STAI) for Adults - Form Y-1, is a measure to evaluate trait and state anxiety and helps to diagnose anxiety and to differentiate it from depressive syndromes
Secondary Outcomes
- Difference in Pain Intensity Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Anxiety Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Depression Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Distress Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Anger Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)