CancerDeCIDE PCNCT05407844
Community Health Worker Based Intervention to Improve Palliative Care
A study testing Community Health Worker (CHW) based palliative care in people with Cancer and End Stage Cancer, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial summary
The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, End Stage Cancer, Malignancy
- What is being tested?
- Community Health Worker (CHW) based palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Nov 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Patient Inclusion Criteria:
- Self-identified African American patients with advanced (AJCC stage III or IV) solid organ malignancy
- >=18 years old
- English speaking
- Intact cognition and ability to provide informed consent
Patient Exclusion Criteria:
- Participants < 18 years of age
- Participants who are already receiving palliative care services
Caregiver Inclusion Criteria:
- Adult (>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)
- English speaking
- Intact cognition and ability to provide informed consent
Caregiver Exclusion Criteria:
- Participants < 18 years of age
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35233
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.
Read the detailed description
This research is being done to establish the effectiveness of a Community Health Worker based palliative care intervention among African American patients with advanced solid organ malignancies and their care givers.
The investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (PC) in African Americans with advanced cancer. The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.
- Conditions
- Cancer, End Stage Cancer, Malignancy, Advanced Cancer
- Being tested
- Community Health Worker (CHW) based palliative care
- Keywords
- palliative care, community health worker
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW) based palliative careOther
Those in the intervention group will receive support from a dedicated CHW trained in motivational interviewing, components of palliative care communication, and social determinants of health.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Standard cancer care |
| Standard care + DeCIDE PC intervention | Experimental | Community health worker support and standard cancer care Receives: Other: Community Health Worker (CHW) based palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completed Advance Directives
Advanced care planning
Measured: 6 months after enrollment
Secondary outcomes (6)
Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score
Quality of Life; Score range: 0-184 [per scoring document, for total score] Higher scores signify better quality of life
Measured: 6 months after enrollment
Number of participants who utilize hospice care
Hospice care utilization within 14 days of death (Yes/No)
Measured: 6 months after enrollment
Goals of care as assessed by Quality of communication (QOC) scale
Goals of Care; Score range: 0-10 [scored 0-10 for each of 19 components] Higher scores signify: higher quality communication with physician
Measured: 6 months after enrollment
Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)
Symptom; Score range: 0-10 [scored 0-10 for 10 components] Higher scores signify: higher intensity of cancer symptoms (worse symptoms)
Measured: 6 months after enrollment
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Symptom; The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.
Measured: 6 months after enrollment
Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)
it assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analogue scale (VAS). Each dimension has five levels ranging from 1 (no problem) to 5 (extreme problem). Score range 0 to 100, higher score indicates better quality of life.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start2 Nov 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Fabian M Johnston, MD, MHS, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407844
- Sponsor's protocol ID
- IRB00119097
- Other IDs
- 1R01CA252101-01A1, 1R01MD016935-01, IRB00283002
- Acronym
- DeCIDE PC
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnston FM, Neiman JH, Parmley LE, Conca-Cheng A, Freund KM, Concannon TW, Smith TJ, Cooper LA. Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer. J Palliat Med. 2019 Mar;22(3):302-306. doi: 10.1089/jpm.2018.0366. Epub 2018 Nov 2.
PubMed 30388060Monton O, Drabo EF, Masroor T, Fuller S, Woods AP, Siddiqi A, Malone TB, Johnston FM. Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol. BMJ Open. 2025 Nov 4;15(11):e096402. doi: 10.1136/bmjopen-2024-096402.
PubMed 41193212Siddiqi A, Monton O, Woods A, Masroor T, Fuller S, Owczarzak J, Yenokyan G, Cooper LA, Freund KM, Smith TJ, Kutner JS, Colborn KL, Joyner R, Elk R, Johnston FM. Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial. BMC Palliat Care. 2023 Sep 18;22(1):139. doi: 10.1186/s12904-023-01250-0.
PubMed 37718442
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker Based Intervention to Improve Palliative Care
- ClinicalTrials.gov ID
- NCT05407844
- Acronym / sponsor ID
- DeCIDE PC / IRB00119097
- Conditions
- Cancer, End Stage Cancer, Malignancy, Advanced Cancer
- Keywords
- palliative care, community health worker
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Jun 2022 (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.
The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.
Detailed description
This research is being done to establish the effectiveness of a Community Health Worker based palliative care intervention among African American patients with advanced solid organ malignancies and their care givers.
The investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (PC) in African Americans with advanced cancer. The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Standard cancer care |
| Standard care + DeCIDE PC intervention | Experimental | Other: Community Health Worker (CHW) based palliative careCommunity health worker support and standard cancer care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Community Health Worker (CHW) based palliative careThose in the intervention group will receive support from a dedicated CHW trained in motivational interviewing, components of palliative care communication, and social determinants of health. | Other | Standard care + DeCIDE PC intervention |
Primary outcome
Number of participants who completed Advance Directives
Time frame: 6 months after enrollment
Advanced care planning
6 secondary outcomes
Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score
Time frame: 6 months after enrollment
Number of participants who utilize hospice care
Time frame: 6 months after enrollment
Goals of care as assessed by Quality of communication (QOC) scale
Time frame: 6 months after enrollment
Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)
Time frame: 6 months after enrollment
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 months after enrollment
Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)
Time frame: 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 30388060Johnston FM, Neiman JH, Parmley LE, Conca-Cheng A, Freund KM, Concannon TW, Smith TJ, Cooper LA. Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer. J Palliat Med. 2019 Mar;22(3):302-306. doi: 10.1089/jpm.2018.0366. Epub 2018 Nov 2.
- Derived from this study: PubMed 41193212Monton O, Drabo EF, Masroor T, Fuller S, Woods AP, Siddiqi A, Malone TB, Johnston FM. Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol. BMJ Open. 2025 Nov 4;15(11):e096402. doi: 10.1136/bmjopen-2024-096402.
- Derived from this study: PubMed 37718442Siddiqi A, Monton O, Woods A, Masroor T, Fuller S, Owczarzak J, Yenokyan G, Cooper LA, Freund KM, Smith TJ, Kutner JS, Colborn KL, Joyner R, Elk R, Johnston FM. Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial. BMC Palliat Care. 2023 Sep 18;22(1):139. doi: 10.1186/s12904-023-01250-0.
- Individual participant dataSharing planned: No
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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.
Fabian M Johnston, MD, MHS principal investigator
Atrium Health Wake Forest Baptist
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW) based palliative care in people with Cancer and End Stage Cancer, run by Wake Forest University Health Sciences at 4 sites 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?
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: enrolling by invitation, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants who completed Advance Directives (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407844, which also lists 3 linked publications.
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 23 Jul 2026.