Preoperative Mindfulness In Musculoskeletal Tumor

NCT ID: NCT04143529

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-09-30

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.

Conditions

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Musculoskeletal Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Personalized acceptance-based mindfulness exercise

Intervention Type BEHAVIORAL

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 second at specific timepoints.

Group Type PLACEBO_COMPARATOR

Brief educational pamphlet

Intervention Type BEHAVIORAL

The control condition will be educational information on pain and stress that patients will read over within 60 seconds

Interventions

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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.

Intervention Type BEHAVIORAL

Brief educational pamphlet

The control condition will be educational information on pain and stress that patients will read over within 60 seconds

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Maria Vranceanu, PhD

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana-Maria Vranceanu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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19-097

Identifier Type: -

Identifier Source: org_study_id

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