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Falls Risk Questionnaire in Older Adults With Cancer

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ClinicalTrials.gov Identifier: NCT02204137
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Cancer Geriatric Assessment Other: Falls Risk Questionnaire Other: Cancer and Aging Research Group Geriatric Assessment Other: Falls Efficacy Scale-International (FES-1) Other: Health Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Falls Risk Questionnaire in Older Adults With Cancer
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Completion of Questionnaires

Participants will complete an assessment consisting of the Falls Risk Questionnaire, a primarily self-administered geriatric assessment (GA) developed by the Cancer and Aging Research Group, a quality of life scale (FACT GOG/NTX) and the Falls Efficacy Scale-International.

Each questionnaire contains approximately 150 questions and will take between 30 minutes and one hour to complete.

Other: Falls Risk Questionnaire
Other: Cancer and Aging Research Group Geriatric Assessment
Other: Falls Efficacy Scale-International (FES-1)
Other: Health Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)



Primary Outcome Measures :
  1. Percent completion of the Fall Risk Questionnaire (FRQ) and the Cancer and Aging Research Group Geriatric Assessment (CARG GA) of enrolled patients [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Time to completion of FRQ and CARG GA of enrolled patients [ Time Frame: Day 1 ]
  2. Satisfaction with the questionnaires [ Time Frame: Day 1 ]
    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

  3. Psychological consequences of falling [ Time Frame: Day 1 ]
    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)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients aged 65 years of age or older
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204137


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Tanya Wildes, M.D., M.S.C.I. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02204137     History of Changes
Other Study ID Numbers: 201407080
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No