NCT02204137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

July 23, 2014

Last Update Submit

April 27, 2017

Conditions

Outcome Measures

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.

    Day 1

Secondary Outcomes (3)

  • Time to completion of FRQ and CARG GA of enrolled patients

    Day 1

  • Satisfaction with the questionnaires

    Day 1

  • Psychological consequences of falling

    Day 1

Study Arms (1)

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 QuestionnaireOther: Cancer and Aging Research Group Geriatric AssessmentOther: 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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients aged 65 years of age or older

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

ST13 protein, human

Study Officials

  • Tanya Wildes, M.D., M.S.C.I.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 30, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations