Locus of Control and Spirituality in Palliative Care Patients

August 25, 2017 updated by: M.D. Anderson Cancer Center

Primary Objectives:

  1. To determine whether the degree of spirituality/religiosity as determined by the Duke University Religion Index and Functional Assessment of Chronic Illness Therapy-Spiritual Well Being Scale (FACIT-Sp) correlates with internal locus of control as determined by the Locus of Control Scale.
  2. To determine the relationships among spiritual-well being, religiosity, hope, depression, and culture, socioeconomic status, and gender in a palliative care setting.
  3. To determine if hope and depression in palliative care patients are affected by the degree of intrinsic and extrinsic spirituality/religiosity.
  4. To determine if patients who believe in predestination correlate with decreased locus of control, but improved quality of life and degree of religiosity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

If you are receiving care in the Palliative Care clinic and are eligible to participate, you will be asked to fill out one-time quality of life surveys, which will take about 40 minutes to complete. The Functional Assessment of Chronic Illness Therapy (FACT-G) survey asks questions about physical and emotional well-being, functional well-being (how much you participate in and enjoy normal daily activities), and social/family well-being.

This study first collected questionnaires from 100 participants from different racial and ethnic backgrounds. When the questionnaires were compared, investigators found some interesting differences between the African American and Caucasian participants. To better understand these findings, an additional 67 African American patients are needed to compare the groups.

The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACT-Sp) asks questions about personal meaning, faith and peace. The Duke University Religion Index (DUREL) asks questions about religious practices. The Locus of Control (LOC) questionnaire asks questions about personal internal control, your views on chance, and your views on power. The Herth Health Scale (HHS) asks questions about hope. The Edmonton Symptom Assessment System (ESAS) asks questions about symptoms you may be experiencing. The Hospital Anxiety and Depression Scale (HADS) asks questions about your feelings of depression and anxiety. The "predetermination" questionnaire asks questions about your beliefs about your fate.

These eight questionnaires will take about 40 minutes to complete and may be completed at a later time if you become tired. Information about you will also be collected (such as your age and gender).

This is an investigational study. About 167 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

100

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
        • University of Texas MD 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

Non-Probability Sample

Study Population

Department of Symptom Control and Palliative Care at MD Anderson Cancer Center

Description

Inclusion Criteria:

  1. Age > 17 years (surveys have not been validated in minors)
  2. Expected survival > 6 weeks
  3. Patients experiencing acute side effects from chemotherapy (mucositis, emesis, or severe grade 2-3 neuropathy) are not eligible
  4. No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
  5. Only new patients presenting to the Department of Symptom Control and Palliative Care Center

Exclusion Criteria:

1) N/A

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Palliative Care Clinic Patients
Department of Symptom Control and Palliative Care Center Patients
Behavioral: Questionnaire
8 questionnaires will take about 40 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of Spirituality/Religiosity in Correlation With Internal Locus of Control.
Time Frame: 40 minutes to complete questionnaires.
40 minutes to complete questionnaires.

Collaborators and Investigators

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

Sponsor

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)

June 3, 2004

Primary Completion (Actual)

August 11, 2017

Study Completion (Actual)

August 11, 2017

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2003-1044
  • NCI-2010-00593 (Registry Identifier: NCI CTRP)

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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