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Locus of Control and Spirituality in Palliative Care Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477243
First Posted: May 23, 2007
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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.

Condition Intervention
Advanced Cancer Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Locus of Control and Spirituality in Palliative Care Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Determination of Spirituality/Religiosity in Correlation With Internal Locus of Control. [ Time Frame: 40 minutes to complete questionnaires. ]

Enrollment: 100
Actual Study Start Date: June 3, 2004
Study Completion Date: August 11, 2017
Primary Completion Date: August 11, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Palliative Care Clinic Patients
Department of Symptom Control and Palliative Care Center Patients
Behavioral: Questionnaire
8 questionnaires will take about 40 minutes to complete.

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Department of Symptom Control and Palliative Care at MD Anderson Cancer Center
Criteria

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

  Contacts and Locations
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): NCT00477243


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477243     History of Changes
Other Study ID Numbers: 2003-1044
NCI-2010-00593 ( Registry Identifier: NCI CTRP )
First Submitted: May 22, 2007
First Posted: May 23, 2007
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Palliative Care Patients
Spirituality
Locus of Control
Questionnaire