Preoperative Mindfulness In Musculoskeletal Tumor

Musculoskeletal Malignancy Clinical Trial

Official title:

Preoperative Mindfulness in Musculoskeletal Tumor Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04143529
• Other study ID #: 19-097
• Status: Withdrawn
• Phase: N/A
• Start date: November 2019
• Est. completion date: September 2021

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Malignancy
• Neoplasms

Intervention

Behavioral:
• Personalized 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.
• Brief educational pamphlet
The control condition will be educational information on pain and stress that patients will read over within 60 seconds

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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