Clinical trial NCT03134404: Project to Assess Feasibility of a Rapid Access Metastatic Bone Disease Program
Official title: A Pilot Project to Assess the Feasibility of Integrating a Multidisciplinary Rapid Access Metastatic Bone Disease Program (RAMP) at The Ottawa Hospital
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metastases to Bone
Keywords: RAMP
Rapid Access
Metastasis to Bone
Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are referred and subsequently followed for a diagnosis of Bone Metastatic Disease of the pelvis or lower extremities arising from a Primary Cancer elsewhere.

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.

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).

Primary outcomes:
measure: Standardization of the referral pathways
timeFrame: 2 years
Secondary outcomes:
measure: Feasibility to triage MBD patients in currently existing musculoskeletal oncology clinics
timeFrame: 2 years
measure: Improve patient flow and timely access to care.
timeFrame: 2 years
measure: Improvement in symptom management and patient satisfaction
timeFrame: 2 years
Other outcomes:
measure: Improvement in counseling MBD patients about mobility aids and fall risk assessment.
timeFrame: 2 years
Locations:
Study officials:
affiliation: OHRI
name: Hesham Abdelbary, MD
role: PRINCIPAL_INVESTIGATOR
References: