Musculoskeletal Malignancy
Conditions
Keywords
Musculoskeletal malignancy
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.
Interventions
BEHAVIORALPersonalized acceptance-based mindfulness exercise
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.
BEHAVIORALBrief educational pamphlet
The control condition will be educational information on pain and stress that patients will read over within 60 seconds
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in State Trait Anxiety Score between Groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in Pain Intensity Score between Groups | from enrollment to the day of admission for surgery up to 3 weeks | Pain Intensity as measured by Ordinal rating of Pain (0-10), this will allow us to measure changes in pain amongst subjects |
| Difference in Distress Score between Groups | from enrollment to the day of admission for surgery up to 3 weeks | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. |
| Difference in Anxiety Score between Groups | from enrollment to the day of admission for surgery up to 3 weeks | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. |
| Difference in Depression Score between Groups | from enrollment to the day of admission for surgery up to 3 weeks | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. |
| Difference in Anger Score between Groups | from enrollment to the day of admission for surgery up to 3 weeks | Mini-Mental Adjustment to Cancer Scale which evaluates the coping across four strategies: anxious preoccupation, fighting spirit, helplessness-hopelessness and positive redefinition. |
Countries
United States
Outcome results
None listed