Preoperative Mindfulness In Musculoskeletal Tumor

Mass General Brigham

Status: Withdrawn

Conditions: Musculoskeletal Malignancy

Treatments: Behavioral: Brief educational pamphlet; Behavioral: Personalized acceptance-based mindfulness exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04143529

19-097

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Personalized acceptance-based mindfulness exercise

Experimental group

Description:

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

Treatment:

Behavioral: Personalized acceptance-based mindfulness exercise

Brief educational pamphlet

Placebo Comparator group

Description:

The control condition will be educational information on pain and stress that patients will read over within 60 second at specific timepoints.

Treatment:

Behavioral: Brief educational pamphlet