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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05356507
• Other study ID #: 2020-0878
• Secondary ID: NCI-2021-12910
• Status: Withdrawn
• Start date: August 29, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Other:
• Patient population
Questionnaires, standard of care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center