NCT00634257

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

14 years

First QC Date

February 25, 2008

Last Update Submit

March 23, 2023

Conditions

Advanced CancerSolid Tumors

Keywords

Advanced CancerSolid TumorsSpiritualityReligiositySymptom DistressQuality of LifeCaregiversQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Association between self-rated spirituality/religiosity and coping strategies

    Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.

Study Arms (2)

Patients

Patients with advanced cancer receiving palliative care.

Behavioral: Questionnaires

Caregivers

Primary caregivers of Patients with advanced cancer receiving palliative care.

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

Nine questionnaires taking about 40 minutes to complete.

Also known as: Survey
CaregiversPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced cancer receiving palliative care and their primary caregivers.

You may qualify if:

  • (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) 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.
  • (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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eduardo Bruera, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 12, 2008

Study Start

February 22, 2008

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

US(1)