Advanced CancerNCT00634257
Spirituality/Religiosity in Patients and Caregivers
An observational study of Advanced Cancer and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: -To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Solid Tumors
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2008to 10 Feb 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with advanced cancer receiving palliative care and their primary caregivers.
Who may be able to join
- (Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center
- (Patients) Patients aged 18 years or over
- (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures).
- (Patients) Able to provide informed consent and comply with study procedures
- (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living
- (Caregivers) Having the patient's consent to be contacted.
Show all 11Show fewer
- (Caregivers) Caregiver is 18 years or over
- (Caregivers) Able to provide informed consent and comply with study procedures
- (Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
- (Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
- (Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
Who cannot join
- 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
Official title: A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
Primary Objective:
-To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.
Read more
Secondary Objectives:
- To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.
- To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).
- To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).
- To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question).
Read the detailed description
Questionnaires:
If you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.
The first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.
The 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)
The last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.
Length of Study Participation:
After completing the questionnaires, your participation in this study will be over.
This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancer, Solid Tumors
- Being tested
- Questionnaires
- Keywords
- Advanced Cancer, Solid Tumors, Spirituality, Religiosity, Symptom Distress, Quality of Life, Caregivers, Questionnaire, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Survey
Nine questionnaires taking about 40 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with advanced cancer receiving palliative care. Receives: Behavioral: Questionnaires | |
| Caregivers | Primary caregivers of Patients with advanced cancer receiving palliative care. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between self-rated spirituality/religiosity and coping strategies
Measured: Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study start22 Feb 2008
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634257
- Sponsor's protocol ID
- 2007-0678
- Other IDs
- NCI-2011-02785
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2008
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
- ClinicalTrials.gov ID
- NCT00634257
- Acronym / sponsor ID
- 2007-0678
- Conditions
- Advanced Cancer, Solid Tumors
- Keywords
- Advanced Cancer, Solid Tumors, Spirituality, Religiosity, Symptom Distress, Quality of Life, Caregivers, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Feb 2008 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 12 Mar 2008 (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 Objective:
-To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.
Secondary Objectives:
- To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.
- To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).
- To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).
- To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question).
Detailed description
Questionnaires:
If you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.
The first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.
The 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)
The last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.
Length of Study Participation:
After completing the questionnaires, your participation in this study will be over.
This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: QuestionnairesPatients with advanced cancer receiving palliative care. |
| Caregivers | – | Behavioral: QuestionnairesPrimary caregivers of Patients with advanced cancer receiving palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced cancer receiving palliative care and their primary caregivers.
Key inclusion criteria (11 listed)
- (Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center
- (Patients) Patients aged 18 years or over
- (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures).
- (Patients) Able to provide informed consent and comply with study procedures
- (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| QuestionnairesAlso: SurveyNine questionnaires taking about 40 minutes to complete. | Behavioural | Caregivers, Patients |
Primary outcome
Association between self-rated spirituality/religiosity and coping strategies
Time frame: Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.
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 27 Mar 2023.
- University of Texas MD Anderson Cancer CenterLink 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.
Eduardo Bruera, 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 and Solid Tumors, 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 11 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 27 Mar 2023. 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?
Association between self-rated spirituality/religiosity and coping strategies (time frame: Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.). 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 27 Mar 2023.