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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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

Other trials in United States

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.

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 groups in NCT05407844
Study groupRoleWhat they receive
Standard careNo interventionStandard cancer care
Standard care + DeCIDE PC interventionExperimentalCommunity 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.

  1. Number of participants who completed Advance Directives

    Advanced care planning

    Measured: 6 months after enrollment

Secondary outcomes (6)

  1. 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

  2. Number of participants who utilize hospice care

    Hospice care utilization within 14 days of death (Yes/No)

    Measured: 6 months after enrollment

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted7 Jun 2022
  2. Study start2 Nov 2023
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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)
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 30388060

  • Monton 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 41193212

  • Siddiqi 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

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.

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