Project to Assess Feasibility of a Rapid Access Metastatic Bone Disease Program

NCT ID: NCT03134404

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-03-31

Brief Summary

The skeletal system is one of the most common sites for metastatic spread of many malignancies. Metastatic bone disease (MBD) can be associated with a significant reduction in quality of life due to debilitating pain and pathologic fractures. Multiple providers are involved in treating patients with MBD which can result in fragmented and delayed delivery of care. This fragmentation also leads to poor outcomes and patient experience. This project will assess whether it is feasible to integrate a multidisciplinary Rapid Access Metastatic Bone Disease Program (RAMP) at the Investigator's institution to improve the delivery of care to patients presenting with pelvic and lower extremity MBD. The goals of RAMP are: 1) Improve outcome and quality of care provided to MBD patients. 2) Improve patients experience through the participant's treatment journey. 3) Avert extra health care costs caused by unplanned admissions through ER and decrease redundancies due to unnecessary multiple clinic visits and double-ordering of diagnostic tests. This project will be designed to optimize the use of existing clinic resources more efficiently. Cancer patients and their loved ones will be actively engaged in the design of this project to better achieve its goals.

Detailed Description

More than 140,000 new cases of cancer are diagnosed annually in Canada, with nearly half of which metastasize to bone. The skeletal system is one of the most common sites for metastatic spread of many visceral malignancies, especially cancers originating from breast, prostate, lung, thyroid and kidney. Hematologic malignancies, such as multiple myeloma and lymphoma, also primarily manifest with multiple aggressive lytic lesions in the bone. A Skeletal Related Event (SRE) is the term given when a metastatic lesion arises in bone. With advances in effective systemic treatment and supportive care, the duration of survival of patients with bone metastases has improved substantially. This improvement in survival can be accompanied by significant morbidity and reduction in quality of life secondary to pain, pathologic fracture, and spinal cord compression from SREs. Pain and impaired mobility occur in approximately 65%-75% of patients with bone metastases. SREs are also associated with high economic burden secondary to increased costs of treatment and high rates of hospitalizations. It is estimated that a single episode of SRE can cost the medical system 36,462 USD. The current literature reflects significant diversity in the approach of diagnosing and treating MBD. Therefore, numerous studies have advocated the need for a multidisciplinary clinic to co-ordinate the diagnosis, treatment, and rehabilitation of patients with MBD patients. This strategy has also been proposed to improve the delivery of early and multimodal palliative management for patients in a cost effective approach.

Aims and Objectives: The aims of this project are: 1) Assess feasibility of establishing and integrating a multidisciplinary Rapid Access Metastatic Bone Disease Program (RAMP) at the Investigator's institution to improve the delivery of care to patients presenting with pelvic and lower extremity MBD. 2) Centralize referrals and streamline clinical care pathways for patients diagnosed with MBD to pelvis and lower extremity. 3) Assess improvement in outcome and patient experience. The objectives of this project are: 1) Establish a core multidisciplinary RAMP team to develop a patient-centered clinical care pathway for diagnosis and treatment. 2) Establish a standardized and rapid referral process for RAMP. 3) Triage consults and coordinate their integration into pre-existing weekly "musculoskeletal oncology" clinic at the cancer center. 4) Develop a centralized registry for patients presenting to RAMP to assess provider performance and evaluate the success of established clinical care pathways.

Conditions

Metastases to Bone

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No Intervention

No Intervention is required for this study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient is 18 years of age or older and able to provide informed consent.
• Patient with an established tissue diagnosis of cancer.
• Patient with diagnosis of metastatic bone lesion which requires a referral to an Orthopedic Oncology Specialist.
• Patient will receive their care and treatment for this metastatic disease at The Ottawa Hospital.

Exclusion Criteria

• Patient does not speak or understand adequate French or English to complete the functional outcome questionnaires.
• Patient has a documented cognitive impairment precluding questionnaire completion (e.g. dementia).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesham Abdelbary, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Other Identifiers

FORM ID 6174

Identifier Type: -

Identifier Source: org_study_id