Advanced CancerNCT00477243
Locus of Control and Spirituality in Palliative Care Patients
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2004to 11 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Symptom Control and Palliative Care at MD Anderson Cancer Center
Who may be able to join
- Age > 17 years (surveys have not been validated in minors)
- Expected survival > 6 weeks
- Patients experiencing acute side effects from chemotherapy (mucositis, emesis, or severe grade 2-3 neuropathy) are not eligible
- No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
- Only new patients presenting to the Department of Symptom Control and Palliative Care Center
Who cannot join
- 1) N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Primary Objectives:
- 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.
- To determine the relationships among spiritual-well being, religiosity, hope, depression, and culture, socioeconomic status, and gender in a palliative care setting.
- To determine if hope and depression in palliative care patients are affected by the degree of intrinsic and extrinsic spirituality/religiosity.
- To determine if patients who believe in predestination correlate with decreased locus of control, but improved quality of life and degree of religiosity.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- Questionnaire
- Keywords
- Advanced Cancer, Palliative Care Patients, Spirituality, Locus of Control, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
8 questionnaires will take about 40 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Clinic Patients | Department of Symptom Control and Palliative Care Center Patients Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Spirituality/Religiosity in Correlation With Internal Locus of Control.
Measured: 40 minutes to complete questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study start3 Jun 2004
- Primary completion11 Aug 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lois M. Ramondetta, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477243
- Sponsor's protocol ID
- 2003-1044
- Other IDs
- NCI-2010-00593
- Status last verified
- Aug 2017
- First submitted
- 22 May 2007
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locus of Control and Spirituality in Palliative Care Patients
- ClinicalTrials.gov ID
- NCT00477243
- Acronym / sponsor ID
- 2003-1044
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Palliative Care Patients, Spirituality, Locus of Control, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Jun 2004 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 23 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- 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.
- To determine the relationships among spiritual-well being, religiosity, hope, depression, and culture, socioeconomic status, and gender in a palliative care setting.
- To determine if hope and depression in palliative care patients are affected by the degree of intrinsic and extrinsic spirituality/religiosity.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Clinic Patients | – | Behavioral: QuestionnaireDepartment of Symptom Control and Palliative Care Center Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Symptom Control and Palliative Care at MD Anderson Cancer Center
Key inclusion criteria (5 listed)
- Age > 17 years (surveys have not been validated in minors)
- Expected survival > 6 weeks
- Patients experiencing acute side effects from chemotherapy (mucositis, emesis, or severe grade 2-3 neuropathy) are not eligible
- No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal
- Only new patients presenting to the Department of Symptom Control and Palliative Care Center
Key exclusion criteria (1 listed)
- 1) N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire8 questionnaires will take about 40 minutes to complete. | Behavioural | Palliative Care Clinic Patients |
Primary outcome
Determination of Spirituality/Religiosity in Correlation With Internal Locus of Control.
Time frame: 40 minutes to complete questionnaires.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lois M. Ramondetta, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Spirituality/Religiosity in Correlation With Internal Locus of Control. (time frame: 40 minutes to complete questionnaires.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.