Clinical trial NCT03979118: Exercise Prescription in Patients With Bone Metastases
Official title: Exercise Prescription in Patients With Bone Metastases: Identifying Clinical Tools to Overcome Clinician Concerns Regarding Skeletal Related Events (Ex-Met Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Bone Metastases
Keywords: Physical Activity
Skeletal Related Events
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: St. James's Hospital, Ireland
name: Tallaght University Hospital
name: Our Lady's Hospice & Care Services, Harold's Cross
First posted: 2019-06-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary breast and prostate cancers who have completed initial systemic or local treatment and have commenced on bone modifying agents (BMAs) will be invited to participate. With an overall study accrual target of n=100, monthly recruitment rates will be monitored and the recruitment strategy will be expanded if necessary, in response to a pre-defined set of accrual milestones.

Brief summary: Cancer which has spread to the bone, causing bone metastases (bone tumours) can weaken bone health and increase risk of fractures (breaks). Consequently, patients can be unsure whether to exercise and health professionals can be unsure what exercise advice is suitable. Despite this, it is well known that exercise improves quality-of-life for patients with bone metastases and therefore it is important that exercise is prescribed to these patients.

This study aims to increase understanding of the link between daily exercise and risk of fracture in patients with bone metastases.

Detailed description: It remains unclear if being physically active increases the risk of skeletal-related events in patients with bone metastases. Many health professionals report fracture risk as the primary concern with exercise prescription, despite a recognition of the importance of exercise participation. Consequently, health professionals can be hesitant to offer exercise advice and many patients are physically inactive. With increasing evidence supporting the benefits of exercise in metastatic bone disease, there is a need to address exercise-related concerns.

Clinical scoring systems such as Mirel's classification, are considered predictive of pathological fracture risk. While scoring algorithms have considerable potential to inform exercise eligibility in this population, to date the applicability of such clinical measures for exercise prescription have been inadequately studied. This study will examine the relationship between habitual physical activity, captured objectively by accelerometry, and skeletal related events (pathologic fracture, spinal cord compression, necessity for radiation to bone or surgery to bone pathological fracture) in patients with metastatic disease (n=100). Clinical data including fracture risk and Skeletal Related Events (SREs), Physical Activity (PA) data and subjective measures of pain, sleep, Quality of Life (QoL) and exercise barriers and benefits will be collected at baseline. Fracture risk will be determined at baseline using Mirel's Classification, which will be assessed by a radiologist affiliated with the study research team.

With treatment advances, patients with bone metastases secondary to advanced cancer are living longer. Consequently, optimising quality-of-life is a key priority and exercise has many recognised benefits in this domain. This research will explore the association between daily activity levels and skeletal complications in patients with bone metastases, by examining methods of identifying patients who are suitable to exercise, therefore improving exercise prescription practice and exercise participation safety.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bone metastases on radiological imaging as a result of breast, prostate or lung cancer.
* Initial systemic or local therapy post-diagnosis completed
* Commenced on bone modifying agents (BMAs)
* Provide signed and dated informed consent form

Exclusion Criteria:

* Cauda equina or metastatic spinal cord compression (MSCC)
* Pre-existing chronic pain (persistent or recurrent pain lasting longer than 3 months) due to orthopedic, rheumatology or fibromyalgia condition

Primary outcomes:
measure: Skeletal Related Events (SRE)
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Bone Mestastases 22(QLQ-BM22)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Exercise Benefits Barriers Scale (EBBS)
timeFrame: Baseline
Other outcomes:
measure: Mirel's Classification
timeFrame: Baseline
Locations:
city: Dublin
country: Ireland
facility: St. James's Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Grainne Sheill, PhD
role: STUDY_DIRECTOR
affiliation: St. James's Hospital and Our Lady's Hospice Harold's Cross
name: Lucy Balding, M.B.,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Tallaght University Hospital
name: Ray McDermott, PhD
role: PRINCIPAL_INVESTIGATOR
References: