NCT05356507

Brief Summary

The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care. The primary objective of this study is to examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

April 11, 2022

Last Update Submit

January 31, 2023

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • To evaluate the Spiritual Needs on Spiritual Well-Being in Patients with Brain Tumors, utilizing the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB).

    Through study completion, an average of 1 year

Interventions

Patient populationOTHER

Questionnaires, standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with a diagnosis of primary or metastatic brain tumors who are scheduled to undergo surgical interventions

You may qualify if:

  • Outpatients at MDACC who are 18 years or older;
  • Are being/have been seen at the MD Anderson Neurosurgery clinic;
  • Have a diagnosis of a primary or metastatic intracranial or skull-based brain, pituitary, or meningeal lesions;
  • Are scheduled to undergo surgical intervention.

You may not qualify if:

  • Have preferred language listed other than English on the chart;
  • Present with cognitive functional impairment, evidence of expressive or receptive aphasia, or gross dysfunction limiting memory or ability to complete a self-report questionnaire, which will be determined by reviewing provider's notes;
  • Refusal to participate in research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anecita Fadol, BLS, MSN, PHD, RN

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 2, 2022

Study Start

August 29, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

US(1)