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The purpose of this study is to investigate the feasibility of early access to mental healthcare during sarcoma treatment as well as to assess the association between early access to psychiatric care and depression, anxiety, postoperative outcomes, and patient satisfaction in patients undergoing surgery for musculoskeletal sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Psychiatric Referral | Experimental | Participants will be randomized to the Early Psychiatric Referral group |
|
| No Referral | No Intervention | Participants will be randomized to the No Referral group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. | Other | The primary intervention in this study is referral to the Memorial Sloan-Kettering Cancer Center (MSK) Department of Psychiatry and Behavioral Sciences. This study will not dictate specific psychiatry interventions beyond providing the referral. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants who complete scheduled study visits | The study will evaluate the feasibility of conducting a randomized clinical trial studying the impact of early referral to psychiatry (versus no referral) on depression and anxiety symptoms in patients with musculoskeletal sarcoma by examining the rates of eligibility, acceptance, uptake rate, and adherence. | 2 years |
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Inclusion Criteria:
Age ≥18 years
Tissue diagnosis of primary bone or soft tissue sarcoma
o Note: high suspicion of sarcoma on history and imaging acceptable, if reviewed and approved by the PI
Presenting to the Orthopaedic Surgery Service
Treatment plan includes surgery at MSK for treatment of the primary sarcoma
No previous treatment for sarcoma
Proficient in English
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bartelstein, MD | Contact | 212-639-8684 | bartelsm@mskcc.org | |
| Yesne Alici, MD | Contact | 646-888-0025 | aliciy@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Meredith Bartelstein, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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|
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All protocol activites) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (All protocol activities) | Recruiting | Uniondale | New York | 11553 | United States |
|
| William Beaumont Army Medical Center | Not yet recruiting | Fort Bliss | Texas | 79918 | United States |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008397 | Masks |
| D001525 | Behavioral Sciences |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004191 | Behavioral Disciplines and Activities |
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