CClinicalTrials.gg
CompletedNCT02204137Updated May 1, 2017

Falls Risk Questionnaire in Older Adults With Cancer

An observational study in Cancer and Geriatric Assessment, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-05-01.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
  • Geriatric Assessment
03

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cancer patients aged 65 years of age or older

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

Exclusion Criteria:

  • Unable to understand written English
  • Psychiatric illness/social situation that would limit compliance with the study requirements
  • Unable to walk.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • OtherFalls Risk Questionnaire
  • OtherCancer and Aging Research Group Geriatric Assessment
  • OtherFalls Efficacy Scale-International (FES-1)
  • OtherHealth Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

Secondary outcomes

  1. Time to completion of FRQ and CARG GA of enrolled patients

    Time frame: Day 1

  2. 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

    Time frame: Day 1

  3. 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)

    Time frame: Day 1

07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02204137
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Jul 30, 2014
Start date
Aug 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
May 1, 2017

Study contacts

Tanya Wildes, M.D., M.S.C.I.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion