Falls Risk Questionnaire in Older Adults With Cancer

Cancer Clinical Trial

Official title:

Pilot Study of the Falls Risk Questionnaire in Older Adults With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204137
• Other study ID #: 201407080
• Status: Completed
• Phase: N/A
• First received: July 23, 2014
• Last updated: April 27, 2017
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is to look at the use of a series of questionnaires evaluating risk for falls in order to collect information that might be used to develop a larger study aiming to recognize who is more at risk for falls and how to best intervene to prevent falls in older adults with cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 or older; 5 patients will be enrolled in each of the following age cohorts:

65-69, 70-74, 75-79, 80 and older

• Diagnosis of cancer, any type

• Currently receiving or anticipated to initiate systemic cancer therapy within 1 month, including endocrine therapy, chemotherapy or targeted therapies

• Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

• Unable to understand written English

• Psychiatric illness/social situation that would limit compliance with the study requirements

• Unable to walk.

Related Conditions & MeSH terms

• Cancer
• Geriatric Assessment

Intervention

Other:
• Falls Risk Questionnaire

• Cancer and Aging Research Group Geriatric Assessment

• Falls Efficacy Scale-International (FES-1)

• Health Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent completion of the Fall Risk Questionnaire (FRQ) and the Cancer and Aging Research Group Geriatric Assessment (CARG GA) of enrolled patients	The percent of patients who complete the assessment will be calculated. Successful completion will be defined as the completion of all items on the questionnaires. If more than 85% of subjects are able to complete the FRQ and CARG GA, the assessment will be deemed feasible.	Day 1
Secondary	Time to completion of FRQ and CARG GA of enrolled patients		Day 1
Secondary	Satisfaction with the questionnaires	We will calculate the frequency of participant feedback that 1) certain questions that were difficult to understand 2) the questionnaire was too short or too long 3) questions were upsetting or 4) the questionnaire left out important questions to ask. Open-ended follow-up questions in which the participants will be given the opportunity to write out their responses will be examined qualitatively for recurring themes of particular questions that were unsatisfactory	Day 1
Secondary	Psychological consequences of falling	Uses the Falls Efficacy Scale-International (FES-I) and Health Related Quality of Life (HRQOL) using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)	Day 1

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine