The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach

January 31, 2023 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

This study will address the following secondary objectives:

  1. To examine bivariate relationships between SB, PsD, and SN.
  2. To explore effects of patients' spirituality on the relationship between patients' SN and SWB.

This study is not powered to test hypotheses concerning the secondary objectives but will specifically examine through descriptive statistics and confidence intervals the following:

  1. SN, PsD, and SB are positively correlated with each other.
  2. SN negatively influences SWB.
  3. SN positively influences spirituality.
  4. Spirituality positively influences SWB.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Anecita Fadol, BLS, MSN, PHD, RN, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2022

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0878
  • NCI-2021-12910 (Other Identifier: NCI-CTRP Clinical Trials Reporting Process)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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