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Exercise Prescription in Patients With Bone Metastases (Ex-Met)
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.
| Condition or disease |
|---|
| Advanced Cancer Bone Metastases |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Exercise Prescription in Patients With Bone Metastases: Identifying Clinical Tools to Overcome Clinician Concerns Regarding Skeletal Related Events (Ex-Met Study) |
| Actual Study Start Date : | October 15, 2019 |
| Estimated Primary Completion Date : | January 2021 |
| Estimated Study Completion Date : | May 2021 |
- Skeletal Related Events (SRE) [ Time Frame: Baseline ]History of pathologic fracture (confirmed on imaging), metastatic spinal cord compression (MSCC), radiation to the bone (for pain or impending fracture), surgery to the bone or pain crisis (requiring intervention or escalation of analgesia)
- Physical Activity [ Time Frame: Baseline ]Physical activity will be assessed using the the ACTi Graph physical activity accelerometer.
- Brief Pain Inventory (BPI) [ Time Frame: Baseline ]The Brief Pain Inventory (BPI), a pain assessment tool that rapidly assesses the severity of pain and its impact on functioning in people living with cancer will be used to measure both the severity of pain (sensory dimension) and interference of pain in the patient's life (reactive dimension). Pain is rated on a scale of 0 (no interference) to 10 (interferes completely). The arithmetic mean of the four severity items is used as a measure of pain severity (mean severity score 0-40 with higher scores indicating higher pain severity). The arithmetic mean of the seven interference items is used as a measure of pain interference (0-70 with a higher score indicating higher levels of pain interference).
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Bone Mestastases 22(QLQ-BM22) [ Time Frame: Baseline ]The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Bone Metastases 22 (QLQ-BM22) will be administered to measure quality of life. The QLQ-BM22 is a 22 item self-administered questionnaire that is divided into the following categories: Painful Sites (PS), Pain Characteristics (PC), Functional Interference (FI), and Psychosocial Aspects (PA). A high score for the symptom scales represents a high level of symptomatology or problems, whilst a high score for the functional scales represents a high level of functioning. All items are scaled from 1 (not at all) to 4 (very much), in which a higher score indicates greater distress in symptom scales while a higher score in functional scale indicates greater functional ability.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline ]The Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire will be used to assess sleep quality. The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totalling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
- Exercise Benefits Barriers Scale (EBBS) [ Time Frame: Baseline ]
The Exercise Benefits / Barriers Scale (EBBS) will be used to measure perceived benefits of and perceived barriers to exercise. The overall perceived-benefits score is calculated by summing up the 29 benefit items, with higher values indicating greater perceived benefits. When the Benefits Scale is used alone, the score range is between 29 and 116. An overall perceived-barriers score is also calculated by summing the 14 barriers items, with higher values indicating greater perceived barriers. When the Barriers Scale is used alone, scores range between 14 and 56.
The instrument is scored in its entirety or as two separate scales. Scores on the total instrument can range from 43 to 172. The higher the score, the more positively the individual perceives exercise.
- Mirel's Classification [ Time Frame: Baseline ]At baseline, a Radiologist affiliated with the study will read the most recently available imaging and report in line with Mirel's classification, a proposed scoring system for diagnosing impending pathologic fractures. Mirel's classification system establishes fracture risk based on site of lesion, size of lesion, nature of lesion and subjective pain severity which provides a score between 4-12. Prophylactic fixation is indicated for a lesion with an overall score of 9 or greater. A lesion with an overall score of 7 or less can be managed using radiotherapy and drugs.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| Contact: Emer M Guinan, PhD | +35318964125 | guinane1@tcd.ie | |
| Contact: Kate E Devenney, PhD | +35318963613 | devennek@tcd.ie |
| Ireland | |
| St. James's Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Kate Devenney | |
| Study Director: | Grainne Sheill, PhD | University of Dublin, Trinity College | |
| Principal Investigator: | Lucy Balding, M.B.,MSc | St. James's Hospital and Our Lady's Hospice Harold's Cross | |
| Principal Investigator: | Ray McDermott, PhD | Tallaght University Hospital |
| Tracking Information | ||||||||||
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| First Submitted Date | May 29, 2019 | |||||||||
| First Posted Date | June 7, 2019 | |||||||||
| Last Update Posted Date | September 10, 2020 | |||||||||
| Actual Study Start Date | October 15, 2019 | |||||||||
| Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures |
Mirel's Classification [ Time Frame: Baseline ] At baseline, a Radiologist affiliated with the study will read the most recently available imaging and report in line with Mirel's classification, a proposed scoring system for diagnosing impending pathologic fractures. Mirel's classification system establishes fracture risk based on site of lesion, size of lesion, nature of lesion and subjective pain severity which provides a score between 4-12. Prophylactic fixation is indicated for a lesion with an overall score of 9 or greater. A lesion with an overall score of 7 or less can be managed using radiotherapy and drugs.
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| Original Other Pre-specified Outcome Measures |
Mirel's Classification [ Time Frame: T0 (Baseline) ] At baseline, a Radiologist affiliated with the study will read the most recently available imaging and report in line with Mirel's classification, a proposed scoring system for diagnosing impending pathologic fractures. Mirel's classification system establishes fracture risk based on site of lesion, size of lesion, nature of lesion and subjective pain severity which provides a score between 4-12. Prophylactic fixation is indicated for a lesion with an overall score of 9 or greater. A lesion with an overall score of 7 or less can be managed using radiotherapy and drugs.
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| Descriptive Information | ||||||||||
| Brief Title | 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) | |||||||||
| 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. |
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| 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. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| 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. | |||||||||
| Condition |
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
100 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | May 2021 | |||||||||
| Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | Ireland | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03979118 | |||||||||
| Other Study ID Numbers | PAL17GUI | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Emer Guinan, University of Dublin, Trinity College | |||||||||
| Study Sponsor | University of Dublin, Trinity College | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University of Dublin, Trinity College | |||||||||
| Verification Date | September 2020 | |||||||||
