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Completed

NCT Number: NCT02204137

Falls Risk Questionnaire in Older Adults With Cancer

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.

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Key information

Conditions

Cancer Geriatric Assessment Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other

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

    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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2014
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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