Musculoskeletal MalignancyNCT04143529
Preoperative Mindfulness In Musculoskeletal Tumor
A study testing Personalized acceptance-based mindfulness exercise and Brief educational pamphlet in people with Musculoskeletal Malignancy, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Malignancy
- What is being tested?
- Personalized acceptance-based mindfulness exercise and Brief educational pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant axis I or II psychopathology that would interfere with participation in the study
- Pregnant patients
- Metastasis at presentation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02115
About this study
Official title: Preoperative Mindfulness in Musculoskeletal Tumor Patients
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
Read the 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.
- Conditions
- Musculoskeletal Malignancy
- Being tested
- Personalized acceptance-based mindfulness exercise, Brief educational pamphlet
- Keywords
- Musculoskeletal malignancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized acceptance-based mindfulness exerciseBehavioural
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 pamphletBehavioural
The control condition will be educational information on pain and stress that patients will read over within 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Personalized acceptance-based mindfulness exercise | Experimental | 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 Receives: Behavioral: Personalized acceptance-based mindfulness exercise |
| Brief educational pamphlet | Placebo comparator | The control condition will be educational information on pain and stress that patients will read over within 60 second at specific timepoints. Receives: Behavioral: Brief educational pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to the day of admission for surgery up to 3 weeks
Secondary outcomes (5)
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
Measured: from enrollment to the day of admission for surgery up to 3 weeks
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.
Measured: from enrollment to the day of admission for surgery up to 3 weeks
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.
Measured: from enrollment to the day of admission for surgery up to 3 weeks
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.
Measured: from enrollment to the day of admission for surgery up to 3 weeks
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.
Measured: from enrollment to the day of admission for surgery up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal MalignancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143529
- Sponsor's protocol ID
- 19-097
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Mindfulness in Musculoskeletal Tumor Patients
- ClinicalTrials.gov ID
- NCT04143529
- Acronym / sponsor ID
- 19-097
- Conditions
- Musculoskeletal Malignancy
- Keywords
- Musculoskeletal malignancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized acceptance-based mindfulness exercise | Experimental | Behavioral: Personalized acceptance-based mindfulness exerciseThe 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 |
| Brief educational pamphlet | Placebo comparator | Behavioral: Brief educational pamphletThe control condition will be educational information on pain and stress that patients will read over within 60 second at specific timepoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- --- English fluency is needed because the intervention (a 60-seconds video) is in English and there is no alternate version available.
Key exclusion criteria (3 listed)
- Significant axis I or II psychopathology that would interfere with participation in the study
- Pregnant patients
- Metastasis at presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized acceptance-based mindfulness exerciseThe 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. | Behavioural | Personalized acceptance-based mindfulness exercise |
| Brief educational pamphletThe control condition will be educational information on pain and stress that patients will read over within 60 seconds | Behavioural | Brief educational pamphlet |
Primary outcome
Difference in State Trait Anxiety Score between Groups
Time frame: 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
5 secondary outcomes
Difference in Pain Intensity Score between Groups
Time frame: from enrollment to the day of admission for surgery up to 3 weeks
Difference in Distress Score between Groups
Time frame: from enrollment to the day of admission for surgery up to 3 weeks
Difference in Anxiety Score between Groups
Time frame: from enrollment to the day of admission for surgery up to 3 weeks
Difference in Depression Score between Groups
Time frame: from enrollment to the day of admission for surgery up to 3 weeks
Difference in Anger Score between Groups
Time frame: from enrollment to the day of admission for surgery up to 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, Ph.D principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized acceptance-based mindfulness exercise and Brief educational pamphlet in people with Musculoskeletal Malignancy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in State Trait Anxiety Score between Groups (time frame: from enrollment to the day of admission for surgery up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.