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

NCT03134404 | Withdrawn

• 1 other identifier: FORM ID 6174
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastases to Bone

Keywords

RAMP; Rapid Access; Metastasis to Bone; Cancer

Outcome Measures

Primary Outcomes (1)

• Standardization of the referral pathways

  Identifying the rate of compliance from the ER, oncology (Medical, radiation and hematology), as well as primary physicians in directing referrals to RAMP. The goal is a compliance rate of 80%. This will be measured by capturing the consults for MBD of the pelvis and lower extremity that were referred outside RAMP referral pathway.

  2 years

Secondary Outcomes (3)

• Feasibility to triage MBD patients in currently existing musculoskeletal oncology clinics

  2 years

• Improve patient flow and timely access to care.

  2 years

• Improvement in symptom management and patient satisfaction

  2 years

Other Outcomes (1)

• Improvement in counseling MBD patients about mobility aids and fall risk assessment.

  2 years

Interventions

No Intervention OTHER

No Intervention is required for this study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Hesham Abdelbary, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: May 1, 2017
• Study Start: November 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share