Preoperative Mindfulness In Musculoskeletal Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Mindfulness in Musculoskeletal Tumor Patients

Conditions
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Musculoskeletal Malignancy

Intervention / Treatment
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* Behavioral: Personalized acceptance-based mindfulness exercise
* Behavioral: Brief educational pamphlet


Participation Criteria
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Eligibility Criteria
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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 Pregnant patients Metastasis at presentation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized acceptance-based mindfulness exercise<br>The purpose of this study is to identify whether a brief 60-second acceptance based mindfulness intervention at specific time points will reduce state trait anxiety, Mini-Mental Adjustment to Cancer Scale score, pain intensity, distress, anxiety, depression and anger | Behavioral: Personalized acceptance-based mindfulness exercise<br>* The mindfulness intervention will be a video-flash found at http://www.pixelthoughts.co. In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.<br>|
| Placebo Comparator: Brief educational pamphlet<br>The control condition will be educational information on pain and stress that patients will read over within 60 second at specific timepoints. | Behavioral: Brief educational pamphlet<br>* The control condition will be educational information on pain and stress that patients will read over within 60 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in State Trait Anxiety Score between Groups | 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 | from enrollment to the day of admission for surgery up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pain Intensity Score between Groups | Pain Intensity as measured by Ordinal rating of Pain (0-10), this will allow us to measure changes in pain amongst subjects | from enrollment to the day of admission for surgery up to 3 weeks | 
| Difference in Distress Score between Groups | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. | from enrollment to the day of admission for surgery up to 3 weeks | 
| Difference in Anxiety Score between Groups | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. | from enrollment to the day of admission for surgery up to 3 weeks | 
| Difference in Depression Score between Groups | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. | from enrollment to the day of admission for surgery up to 3 weeks | 
| Difference in Anger Score between Groups | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. | from enrollment to the day of admission for surgery up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musculoskeletal malignancy