Clinical trial NCT00477243: Locus of Control and Spirituality in Palliative Care Patients
Official title: Locus of Control and Spirituality in Palliative Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Keywords: Advanced Cancer
Palliative Care Patients
Spirituality
Locus of Control
Questionnaire
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Symptom Control and Palliative Care at MD Anderson Cancer Center

Brief summary: 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.

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 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

Primary outcomes:
measure: Determination of Spirituality/Religiosity in Correlation With Internal Locus of Control.
timeFrame: 40 minutes to complete questionnaires.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lois M. Ramondetta, MD
role: PRINCIPAL_INVESTIGATOR
References: