Cancer Clinical Trial
Official title:
Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy
NCT number | NCT02737839 |
Other study ID # | 201603069 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 9, 2016 |
Est. completion date | January 14, 2020 |
Verified date | October 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic disease self-management is the ability of the individual, in conjunction with family, community and healthcare professionals to manage symptoms, treatments, lifestyle changes and psychosocial, cultural and spiritual consequences associated with a chronic condition. Self-management strategies have been successfully used in supportive care and survivorship in oncology. Stepping On, a multi-component program using a small-group learning environment, reduces falls by 31%. It empowers participants with knowledge about fall-risk, exercise, medications and environmental hazards to self-manage their risk of falls over 7 weeks of educational sessions, followed by a home visit. The research in this proposal will yield the adaptation of the effective group-education-based fall-prevention intervention Stepping On, tailored to cancer patients, feasible for testing in a multi-institutional trial, and ultimately scalable in the oncology setting.
Status | Completed |
Enrollment | 101 |
Est. completion date | January 14, 2020 |
Est. primary completion date | January 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria for Patient Participants: - Age =70 years. - Reports a fall within the past 1 year OR self-reports that they are concerned about falling. - Receiving systemic cancer therapy (including conventional chemotherapy, novel/targeted agents, immunotherapy, monoclonal antibody therapy, oral tyrosine kinase inhibitors, or hormonal agents) OR will begin systemic therapy within the next 4 weeks. - Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria for Patient Participants: - Life expectancy <6 months. - Unable to understand written or spoken English. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of participants who completed the 7 education sessions | -The Pilot Waves will only be looked at for this outcome measure | Completion of all participants in the Pilot Wave groups (approximately 85 weeks) | |
Secondary | Percent of participants consented among approached potential participants | -The Pilot Waves will only be looked at for this outcome measure | Completion of accrual (approximately 18 months) | |
Secondary | Fall rate during participation | -The Pilot Waves will only be looked at for this outcome measure | Completion of participation (approximately 20 weeks) | |
Secondary | Changes in score in the Falls-Efficacy Scale - International as measured by fear-of-falling | -The Pilot Waves will only be looked at for this outcome measure | Completion of participation (approximately 20 weeks) | |
Secondary | Behavior change intention in preventing falls | The Pilot Waves will only be looked at for this outcome measure To measure behavior change intention in preventing falls the participant will be asked 24 questions about how they prevent falls. Answers to choose from include never, sometimes, often, always, or does not apply. |
Completion of participation (approximately 20 weeks) | |
Secondary | Change in Pain Patient Reported Outcome (PRO) | -5 questions to ask participant about their pain levels and how the pain interfered with their daily lives, answers range from not at all to very much | Completion of participation (approximately 20 weeks) | |
Secondary | Measure changes in balance waves | -The Gait & Balance Waves will only be looked at for this outcome measure | Baseline and 1 month after completion of participation (approximately 20 weeks) | |
Secondary | Measure changes in gait waves | -The Gait & Balance Waves will only be looked at for this outcome measure | Baseline and 1 month after completion of participation (approximately 20 weeks) |
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