Preoperative Mindfulness In Musculoskeletal Tumor

Not Applicable

Withdrawn

• Conditions: Musculoskeletal Malignancy
• Interventions: Behavioral: Brief educational pamphlet; Behavioral: Personalized acceptance-based mindfulness exercise

• Registration Number: NCT04143529
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2019-11
• Primary Completion: 2020-09
• Status Verified: 2021-09
• Study Completion: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief educational pamphlet	Brief educational pamphlet	The control condition will be educational information on pain and stress that patients will read over within 60 second at specific timepoints.
Personalized acceptance-based mindfulness exercise	Personalized acceptance-based mindfulness exercise	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States