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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05356507
Collaborator
(none)
169
1
11
15.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient population

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 Design

Study Type:
Observational
Anticipated Enrollment :
169 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach
Anticipated Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
May 31, 2023

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05356507
Other Study ID Numbers:
  • 2020-0878
  • NCI-2021-12910
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022