Clinical trial NCT05356507: The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach
Official title: The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Tumor
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a diagnosis of primary or metastatic brain tumors who are scheduled to undergo surgical interventions

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anecita Fadol, BLS, MSN, PHD, RN
role: PRINCIPAL_INVESTIGATOR
References: