CancerNCT05162807
Intervention to Improve Caregiver Palliative Care Knowledge and Attitudes
A study testing Psychoeducational Video on Palliative Care and Educational Video on Nutrition in people with Cancer, run by Tulane University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Psychoeducational Video on Palliative Care and Educational Video on Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2021to 26 Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Provide informed consent
- 18 years of age or older
- Have ever had a close friend or family member diagnosed with cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Psychoeducational Video on Palliative Care, Educational Video on Nutrition
- Keywords
- Palliative care, Caregiver
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational Video on Palliative CareBehavioural
The intervention is a psychoeducational video introducing palliative care and discussing its purpose, structure, benefits, and efficacy.
Educational Video on NutritionBehavioural
The attention control is a video on nutrition and healthy eating during cancer survivorship.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Education | Experimental | The intervention arm will view a psychoeducational video on palliative care. Receives: Behavioral: Psychoeducational Video on Palliative Care |
| Attention Control | Placebo comparator | The control arm will view an educational video on nutrition as an attention control. Receives: Behavioral: Educational Video on Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative Care Knowledge Scale (PaCKS)
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.
Measured: Immediately post-intervention
Palliative Care Attitudes Scale - Caregiver (PCAS-9C)
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start19 Dec 2021
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between groups, randomized design. Participants are randomized to either intervention or control conditions.
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenna K Mossman, Tulane University
- Investigators
- Brenna K Mossman, MA, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162807
- Sponsor's protocol ID
- 2020-1041
- Status last verified
- Apr 2022
- First submitted
- 23 Nov 2021
- Last updated
- 27 Apr 2022
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Caregiver Palliative Care Knowledge and Attitudes: Evaluating the Impact of a Psychoeducational Intervention
- ClinicalTrials.gov ID
- NCT05162807
- Acronym / sponsor ID
- 2020-1041
- Conditions
- Cancer
- Keywords
- Palliative care, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Between groups, randomized design. Participants are randomized to either intervention or control conditions.
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Education | Experimental | Behavioral: Psychoeducational Video on Palliative CareThe intervention arm will view a psychoeducational video on palliative care. |
| Attention Control | Placebo comparator | Behavioral: Educational Video on NutritionThe control arm will view an educational video on nutrition as an attention control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide informed consent
- 18 years of age or older
- Have ever had a close friend or family member diagnosed with cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Psychoeducational Video on Palliative CareThe intervention is a psychoeducational video introducing palliative care and discussing its purpose, structure, benefits, and efficacy. | Behavioural | Palliative Care Education |
| Educational Video on NutritionThe attention control is a video on nutrition and healthy eating during cancer survivorship. | Behavioural | Attention Control |
Primary outcome
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.
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.
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 Apr 2022.
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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.
Brenna K Mossman, MA principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Video on Palliative Care and Educational Video on Nutrition in people with Cancer, run by Tulane University 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 3 inclusion and 0 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 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Palliative Care Knowledge Scale (PaCKS) (time frame: Immediately post-intervention). The study lists 2 primary outcomes in all. 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 Apr 2022.