Clinical trial NCT04143529: Preoperative Mindfulness In Musculoskeletal Tumor
Official title: Preoperative Mindfulness in Musculoskeletal Tumor Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Musculoskeletal Malignancy
Keywords: Musculoskeletal malignancy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in State Trait Anxiety Score between Groups
timeFrame: from enrollment to the day of admission for surgery up to 3 weeks
Secondary outcomes:
measure: Difference in Pain Intensity Score between Groups
timeFrame: from enrollment to the day of admission for surgery up to 3 weeks
measure: Difference in Distress Score between Groups
timeFrame: from enrollment to the day of admission for surgery up to 3 weeks
measure: Difference in Anxiety Score between Groups
timeFrame: from enrollment to the day of admission for surgery up to 3 weeks
measure: Difference in Depression Score between Groups
timeFrame: from enrollment to the day of admission for surgery up to 3 weeks
measure: Difference in Anger Score between Groups
timeFrame: from enrollment to the day of admission for surgery up to 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: