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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03671226
Other study ID # 2018-0573
Secondary ID NCI-2018-0187720
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 28, 2018
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies the preference of room setting and waiting time in patients with cancer that has spread to nearby tissue or lymph nodes or other places in the body and their caregivers who are seen in the outpatient supportive/palliative care center. Room setting preferences of patients and caregivers may help to understand their opinion regarding direct rooming system in the outpatient supportive/palliative care center.


Description:

PRIMARY OBJECTIVES: I. To determine patients and caregivers preferences regarding the rooming process in outpatient supportive palliative care clinic, measured by the preference to exam room versus waiting area. SECONDARY OBJECTIVES: I. Patients and caregiver perceptions regarding room setting and waiting time in the outpatient supportive care clinic. II. Extent/experience of team contact in the outpatient supportive care clinic. III. The factors associated with rooming preferences such as age, gender, symptom distress and performance status. IV. The association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and perception of usefulness of the visit to palliative care center. V. The attitudes and beliefs toward usefulness of referral to outpatient palliative care. VI. The correlation between the patient and caregivers preferences. OUTLINE: Patients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 406
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient: Have advanced cancer, defined as locally advanced, metastatic or incurable disease. - Patient: Seen at University of Texas M. D. Anderson Cancer Center (UTMDACC) outpatient Supportive Care Center for consultation (first visit). - Patient: Provided informed consent. - Patient: Can read and speak English or Spanish. - Patient: Has a consenting caregiver at the time of the Supportive Care consultation visit. - Caregiver: Provided informed consent. - Caregiver: Can read and speak English or Spanish. - Caregiver: Must be with consenting patient at the time of the Supportive Care consultation visit. Exclusion Criteria: - Patient: Delirium diagnosed by palliative care physician or nurse and/or Memorial Delirium Assessment Scale (MDAS) >= 7 or dementia. - Patient: Inability to read and speak English or Spanish. - Patient: No caregiver at the time of Supportive Care consultation visit. - Caregiver: Inability to read and speak English or Spanish.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire Administration
Given questionnaire

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preference of exam room over waiting room as soon as checking in until the nurse is ready for a patient assessed using questionnaire Two sample t-test or Wilcoxon rank sum test, whichever more appropriate, will be used to compare continuous variables of interest between the preference of exam room over waiting area. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between each of categorical variables and preference of exam room over waiting area. Univariate/multicovariate logistic regression analysis will be used to explore the demographics and clinical factors associated with rooming preferences. Up to 3 days after visit
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