Advanced CancerEx-MetNCT03979118
Exercise Prescription in Patients With Bone Metastases
An observational study of Advanced Cancer and Bone Metastases, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Bone Metastases
- How many people
- 58 participants
- Where
- 1 siteIreland
- Study dates
- 15 Oct 2019to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Prescription in Patients With Bone Metastases: Identifying Clinical Tools to Overcome Clinician Concerns Regarding Skeletal Related Events (Ex-Met Study)
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.
Read the 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.
- Conditions
- Advanced Cancer, Bone Metastases
- Keywords
- Physical Activity, Skeletal Related Events
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Related Events (SRE)
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)
Measured: Baseline
Physical Activity
Physical activity will be assessed using the the ACTi Graph physical activity accelerometer.
Measured: Baseline
Secondary outcomes (4)
Brief Pain Inventory (BPI)
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).
Measured: Baseline
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Bone Mestastases 22(QLQ-BM22)
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.
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline
Exercise Benefits Barriers Scale (EBBS)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start15 Oct 2019
- Primary completion1 Apr 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Cancer Society, St. James's Hospital, Ireland, Tallaght University Hospital, Our Lady's Hospice & Care Services, Harold's Cross
- Responsible party
- Principal investigator, Emer Guinan, University of Dublin, Trinity College
- Investigators
- Grainne Sheill, PhD, Study director, University of Dublin, Trinity CollegeLucy Balding, M.B.,MSc, Principal investigator, St. James's Hospital and Our Lady's Hospice Harold's CrossRay McDermott, PhD, Principal investigator, Tallaght University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979118
- Sponsor's protocol ID
- PAL17GUI
- Acronym
- Ex-Met
- Status last verified
- May 2022
- First submitted
- 29 May 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Prescription in Patients With Bone Metastases: Identifying Clinical Tools to Overcome Clinician Concerns Regarding Skeletal Related Events (Ex-Met Study)
- ClinicalTrials.gov ID
- NCT03979118
- Acronym / sponsor ID
- Ex-Met / PAL17GUI
- Conditions
- Advanced Cancer, Bone Metastases
- Keywords
- Physical Activity, Skeletal Related Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Irish Cancer Society, St. James's Hospital, Ireland, Tallaght University Hospital, Our Lady's Hospice & Care Services, Harold's Cross
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: Baseline
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Bone Mestastases 22(QLQ-BM22)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Exercise Benefits Barriers Scale (EBBS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grainne Sheill, PhD study director
University of Dublin, Trinity College
Lucy Balding, M.B.,MSc principal investigator
St. James's Hospital and Our Lady's Hospice Harold's Cross
Ray McDermott, PhD principal investigator
Tallaght University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Bone Metastases, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Related Events (SRE) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.