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CompletedNCT03656224Updated Aug 23, 2021

Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in Participants With Cancer

An observational study in Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-23.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
261
Ages
18 Years and older
Sex
All
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Study summary

This trial studies a survey of post-acute inpatient rehabilitation safety concerns in participants with cancer. Collecting patients' feedback via surveys may help doctors to learn more about the safety concerns that patients have when they are discharged from the acute inpatient cancer rehabilitation unit.

Read the detailed description

PRIMARY OBJECTIVES:

I. Assess patients' perceptions regarding safety after acute inpatient rehabilitation at discharge and after approximately one month from discharge date.

SECONDARY OBJECTIVES:

I. Assess patient's perception of factors impacting continuity of care at discharge and after approximately one month from discharge date.

II. Determine the frequency of reported falls and the circumstance surrounding reported falls during hospitalization and within approximately one month from discharge date.

III. Determine the frequency of reported near falls and the circumstance surrounding reported near falls within approximately one month from discharge date.

IV. Identify demographic and clinical characteristics associated with feeling safe and unsafe.

OUTLINE:

Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.

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Conditions studied

  • Malignant Neoplasm

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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 261 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 579 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

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

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Who can participate

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

Study population

Participants who are discharged from the acute cancer inpatient rehabilitation unit to personal residence

Inclusion criteria

  • All patients who are discharged from the acute cancer inpatient rehabilitation unit to personal residence (house, apartment, condominium, hotel, assisted living, etc.)
  • Patients who provide informed consent
  • English-speaking participants

Exclusion criteria

Exclusion Criteria:

  • Patients discharged to another hospital or health facility (Skilled Nursing Facility [SNF], Long Term Acute Care Hospital [LTACH], inpatient hospice, etc.)
  • Patients with moderate to severe cognitive deficits as determined by speech language pathologist and/or rehabilitation physician
  • Patients who were re-hospitalized at any time during study period (since completion of first survey in the hospital and discharged from the hospital until approximately one month after discharge
  • Patients who were readmitted to acute inpatient rehabilitation service and previously completed both surveys
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
261 participants (actual)

Groups and cohorts

  • Observational (survey)

    Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.

    Other: Survey Administration

Interventions

  • OtherSurvey Administration

    Ancillary studies

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What researchers measure

Primary outcomes

  1. Patients' perceptions regarding safety after acute inpatient rehabilitation

    Will be assessed by Patient Continuity of Care Checklist and Perceptions Regarding Safety after Rehabilitation. At the end of study, patients' demographics and clinical characteristics will be summarized for all the patients who participated in the study by standard descriptive statistics such as mean, standard deviation, median, and range for continuous variables and frequency and proportion for categorical variables. The association between these characteristics and feeling safe will be evaluated by Wilcoxon rank sum test and chi-square (or Fisher's exact) test for continuous and categorical variables, respectively. The proportion of patients who claim they feel safe at each time will be estimated and reported along with the 95% Clopper-Pearson exact confidence interval. McNemar's test will be applied to evaluate whether the status of feeling safe has changed from the time of discharge to one month afterwards.

    Time frame: 1 month after discharge

Secondary outcomes

  1. Frequency of experiencing falls and/or near falls

    Will be calculated and reported along with a 95% confidence interval. Furthermore, circumstances surrounding reported falls collected by question 19 and 20 in the survey will be summarized by descriptive statistics. Answers about other aspects of safety concerns collected by the questionnaire will be reported by descriptive statistics. To further investigate the association of sociodemographic and disease characteristics of patients with their perception of safety logistic regression models may be applied. Answers to "Patient Continuity of Care Checklist" questionnaire will be summarized and subscale scores will be calculated. Subscale scores will be compared between patients with different safety perception by applying Wilcoxon rank sum test. All tests will be performed two-sided and at 5% nominal significance level unless otherwise stated. Other statistical approaches may be utilized when appropriate.

    Time frame: 1 month after discharge

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Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03656224
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 4, 2018
Start date
Aug 29, 2018
Primary completion
Aug 16, 2021
Completion
Aug 16, 2021
Last update
Aug 23, 2021

Study contacts

Jegy Tennison
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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