Exercise Prescription in Patients With Bone Metastases

NCT03979118 | Completed

• 1 other identifier: PAL17GUI
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer; Bone Metastases

Keywords

Physical Activity; Skeletal Related Events

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline

• Physical Activity

  Physical activity will be assessed using the the ACTi Graph physical activity accelerometer.

  Baseline

Secondary Outcomes (4)

• Brief Pain Inventory (BPI)

  Baseline

• European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Bone Mestastases 22(QLQ-BM22)

  Baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline

• Exercise Benefits Barriers Scale (EBBS)

  Baseline

Other Outcomes (1)

• Mirel's Classification

  Baseline

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 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Irish Cancer Society: collaborator
• St. James's Hospital, Ireland: collaborator
• Tallaght University Hospital: collaborator
• Our Lady's Hospice & Care Services, Harold's Cross: collaborator

Study Sites (1)

St. James's Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Grainne Sheill, PhD

  University of Dublin, Trinity College

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 7, 2019
• Study Start: October 15, 2019
• Primary Completion: April 1, 2021
• Study Completion: January 31, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

IE (1)