- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162807
Intervention to Improve Caregiver Palliative Care Knowledge and Attitudes
April 26, 2022 updated by: Brenna K Mossman, Tulane University
Improving Caregiver Palliative Care Knowledge and Attitudes: Evaluating the Impact of a Psychoeducational Intervention
This randomized clinical trial will assess whether a psychoeducational intervention will improve palliative care knowledge and attitudes among close friends and family members of individuals with cancer.
The psychoeducational intervention entails viewing a video introducing palliative care and its purpose, structure, benefits, and efficacy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary aims of this randomized clinical trial are to examine the impact of a psychoeducational intervention on (1) palliative care knowledge, and (2) palliative care attitudes among close friends and family members of individuals with cancer.
Participants will complete a baseline survey including measures of palliative care knowledge and experience.
Participants will be randomized to then view either a psychoeducational video introducing palliative care (intervention) or an educational video on nutrition throughout cancer survivorship (attention control).
All participants will then complete outcome measures, including primary outcomes of palliative care knowledge and attitudes.
Study Type
Interventional
Enrollment (Actual)
395
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70118
- Tulane University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Provide informed consent
- 18 years of age or older
- Have ever had a close friend or family member diagnosed with cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Palliative Care Education
The intervention arm will view a psychoeducational video on palliative care.
|
The intervention is a psychoeducational video introducing palliative care and discussing its purpose, structure, benefits, and efficacy.
|
|
Placebo Comparator: Attention Control
The control arm will view an educational video on nutrition as an attention control.
|
The attention control is a video on nutrition and healthy eating during cancer survivorship.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Palliative Care Knowledge Scale (PaCKS)
Time Frame: Immediately post-intervention
|
Participants in both groups will complete the 13-item Palliative Care Knowledge Scale (PaCKS).
The scale presents a series of items about palliative care, and response options reflect whether participants believe the items are true or false, or whether the participant does not know the answer.
Each correct answer will be scored as 1, each incorrect or unsure answer will be scored as 0, and correct responses will be summed to create a total score.
The total score will range from 0-13, with higher scores indicating greater palliative care knowledge.
|
Immediately post-intervention
|
|
Palliative Care Attitudes Scale - Caregiver (PCAS-9C)
Time Frame: Immediately post-intervention
|
Participants in both groups will report attitudes toward palliative care by completing the 9-item Palliative Care Attitudes Scale for Caregivers (PCAS-9C).
The PCAS-9C consists of three subscales with three items each: emotional (reverse-coded), cognitive, and behavioral.
Participants rate each item from 1 to 5. Total scores will range from 9 to 45, with higher scores indicating more favorable attitudes towards palliative care.
|
Immediately post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brenna K Mossman, MA, Tulane University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2021
Primary Completion (Actual)
March 26, 2022
Study Completion (Actual)
March 26, 2022
Study Registration Dates
First Submitted
November 23, 2021
First Submitted That Met QC Criteria
December 6, 2021
First Posted (Actual)
December 17, 2021
Study Record Updates
Last Update Posted (Actual)
April 27, 2022
Last Update Submitted That Met QC Criteria
April 26, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-1041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Atrium Health Wake Forest BaptistRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Vanderbilt-Ingram Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Yale UniversityNational Institute of Nursing Research (NINR); The Glimpse Group IncRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Palleon Pharmaceuticals, Inc.CompletedMelanoma | Cancer | Breast Cancer | Head and Neck Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Ovarian Cancer | NSCLC | Non Small Cell Lung Cancer | Bladder Cancer | Colon Cancer | Urothelial Cancer | Oncology | CRC | Esophagogastric Junction Cancer | EGJUnited States
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
Clinical Trials on Psychoeducational Video on Palliative Care
-
University of AarhusAarhus University HospitalCompleted
-
Our Lady's Hospice and Care ServicesRoyal Surrey County Hospital NHS Foundation TrustRecruiting
-
Women and Infants Hospital of Rhode IslandCompleted
-
Stanford UniversityCompleted
-
Allina Health SystemCompleted
-
IRCCS National Neurological Institute "C. Mondino...RecruitingNeurodevelopmental DisordersItaly
-
Jahangirnagar UniversityBangladesh University Grants Commission (UGC)Recruiting
-
Augusto CaraceniRecruitingCancer | Frailty | Palliative Care | Outpatient | Palliative Care, Health Services | Patient Reported Outcome Measurements | Patient Reported Outcome (PRO)Italy
-
Massachusetts General HospitalPatient-Centered Outcomes Research InstituteRecruitingHigh Risk Acute Myeloid Leukemia | Relapsed Adult AML | Primary Refractory Acute Myeloid LeukemiaUnited States
-
Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Palliative Care Research Cooperative...CompletedLung CancerUnited States