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

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ClinicalTrials.gov Identifier: NCT05356507
Recruitment Status : Recruiting
First Posted : May 2, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Brain Tumor 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.

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Study Type : Observational
Estimated 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
Actual Study Start Date : August 29, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors


Intervention Details:
  • Other: Patient population
    Questionnaires, standard of care


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). [ Time Frame: Through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with a diagnosis of primary or metastatic brain tumors who are scheduled to undergo surgical interventions
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05356507


Contacts
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Contact: Anecita Fadol, BLS, MSN, PHD, RN (832) 817-8997 afadol@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anecita Fadol, BLS, MSN, PHD, RN    (832) 817-8997    afadol@mdanderson.org   
Principal Investigator: Anecita Fadol, BLS, MSN, PHD, RN         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Anecita Fadol, BLS, MSN, PHD, RN M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05356507    
Other Study ID Numbers: 2020-0878
NCI-2021-12910 ( Other Identifier: NCI-CTRP Clinical Trials Reporting Process )
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases