CancerNCT05828927
enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
A study testing Eco-mapping tool and Caregiver-coach study visits in people with Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Eco-mapping tool and Caregiver-coach study visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 24 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for caregivers In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- English-speaking.
- Ability to provide written or electronic informed consent to participate in the study.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent. Identify as an informal (unpaid) caregiver for a rural-dwelling adult with a stage II-IV solid tumor or any hematologic malignancy in active treatment (see eligibility criteria for patients).
- Inclusion criteria for subjects with cancer In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Show all 12Show fewer
- Their identified caregiver is enrolled in the study
- English-speaking.
- Ability to provide written or electronic informed consent to participate in the study.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent. Have a diagnosis of stage II-IV solid tumor or any hematologic malignancy receiving active treatment s, not including hormonal therapy
- 7. Live in a rural area according to the USDA's Rural/Urban Commuting Area (RUCA) score of >4.
Who cannot join
- Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
- Participation in the intervention development phase of this intervention.
- Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
- Their caregiver does not enroll in the study or withdraws consent
Trial locations and contacts
1 site in 1 country.
About this study
This study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. enCompass Carolina is a social support intervention, that supports caregivers by helping them find and use new sources of support. The purpose of this study is to test and receive feedback about the program.
- Conditions
- Cancer
- Being tested
- Eco-mapping tool, Caregiver-coach study visits
- Keywords
- social support, rural, caregivers, coaching
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eco-mapping toolBehavioural
The web application allows caregivers to visually identify and organize their existing social network (family, friends, community of worship, and others) to assist with their support needs, tailored to their context. For each of the six support social support domains (in-home, informational, communication, financial, emotional and spiritual, transportation (e.g., emotional, informational, practical), the enCompass web application prompts the individual to identify members of their network. After completing each domain, caregivers are presented with a visual social support
Caregiver-coach study visitsBehavioural
Caregivers engage in up to 8 manualized, telephone/videoconference visits with a trained caregiver coach. The caregiver coach uses the study manual and interview guide to provide support for caregiver support-seeking and problem-solving.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver of subject with cancer | Other | Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer. Receives: Behavioral: Eco-mapping tool; Behavioral: Caregiver-coach study visits |
| Subject with Cancer | No intervention | Subjects is with cancer and receive care from caregivers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility - caregiver enrollment
Study feasibility will be measured by caregiver enrollment rates, defined as the proportion of eligible caregivers approached about the study who consent to participate.
Measured: 8 weeks
Study feasibility - Caregiver intervention engagement
Study feasibility will be measured by caregiver intervention engagement, defined as the proportion of enrolled caregiver subjects who receive at least one intervention visit.
Measured: 8 weeks
Secondary outcomes (3)
Intervention acceptability-qualitative
Intervention acceptability will be measured using the Acceptability of the Intervention Measure (AIM) survey scores.
AIM is a survey questionnaire that includes 4 questions. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse-coded.
Measured: 4 weeks, 8 weeks
Intervention acceptability-quantitative
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
Measured: 4 weeks, 8 weeks
Caregiver self-efficacy
Caregiver self-efficacy will be measured using the Coping Self-Efficacy Scale (CSES).
The CSES is a 26-item measure of one's confidence in performing coping behaviour when facing life challenges. It measures the use of problem-focused coping, receiving of social support and stopping unpleasant emotions and thoughts. Scores range from not at all confident=0 to very confident=100. A score of 0 means 'extremely low self efficacy' and a score of 100 means 'extremely high self efficacy'.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 May 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Erin E Kent, PhD, MS, Principal investigator, Department of Health Policy and Management Gillings School of Global Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828927
- Sponsor's protocol ID
- LCCC2242
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kent EE, Deal AM, Sperry SS, Nakamura ZM, Gellin M, Kovacs J, Martin C, Reblin M. Feasibility and Acceptability of an 8-Week Supportive Care Intervention for Cancer Caregivers Adapted for Rural Settings. Psychooncology. 2025 Dec;34(12):e70341. doi: 10.1002/pon.70341.
PubMed 41310279Kent EE, Tan KR, Nakamura ZM, Kovacs J, Gellin M, Deal A, Park EM, Reblin M. Building on and tailoring to: Adapting a cancer caregiver psychoeducational intervention for rural settings. Cancer Med. 2024 Sep;13(17):e70187. doi: 10.1002/cam4.70187.
PubMed 39234997
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
- ClinicalTrials.gov ID
- NCT05828927
- Acronym / sponsor ID
- LCCC2242
- Conditions
- Cancer
- Keywords
- social support, rural, caregivers, coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- 15 May 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 25 Apr 2023 (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 study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. enCompass Carolina is a social support intervention, that supports caregivers by helping them find and use new sources of support. The purpose of this study is to test and receive feedback about the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver of subject with cancer | Other | Behavioral: Eco-mapping tool, Behavioral: Caregiver-coach study visitsAdults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer. |
| Subject with Cancer | No intervention | –Subjects is with cancer and receive care from caregivers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Inclusion criteria for caregivers In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- English-speaking.
- Ability to provide written or electronic informed consent to participate in the study.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent. Identify as an informal (unpaid) caregiver for a rural-dwelling adult with a stage II-IV solid tumor or any hematologic malignancy in active treatment (see eligibility criteria for patients).
Key exclusion criteria (6 listed)
- Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
- Participation in the intervention development phase of this intervention.
- Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
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 |
|---|---|---|
| Eco-mapping toolThe web application allows caregivers to visually identify and organize their existing social network (family, friends, community of worship, and others) to assist with their support needs, tailored to their context. For each of the six support social support domains (in-home, informational, communication, financial, emotional and spiritual, transportation (e.g., emotional, informational, practical), the enCompass web application prompts the individual to identify members of their network. After completing each domain, caregivers are presented with a visual social support | Behavioural | Caregiver of subject with cancer |
| Caregiver-coach study visitsCaregivers engage in up to 8 manualized, telephone/videoconference visits with a trained caregiver coach. The caregiver coach uses the study manual and interview guide to provide support for caregiver support-seeking and problem-solving. | Behavioural | Caregiver of subject with cancer |
Primary outcome
Study feasibility - caregiver enrollment
Time frame: 8 weeks
Study feasibility will be measured by caregiver enrollment rates, defined as the proportion of eligible caregivers approached about the study who consent to participate.
Study feasibility - Caregiver intervention engagement
Time frame: 8 weeks
Study feasibility will be measured by caregiver intervention engagement, defined as the proportion of enrolled caregiver subjects who receive at least one intervention visit.
3 secondary outcomes
Intervention acceptability-qualitative
Time frame: 4 weeks, 8 weeks
Intervention acceptability-quantitative
Time frame: 4 weeks, 8 weeks
Caregiver self-efficacy
Time frame: Baseline, 4 weeks, 8 weeks
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 30 Mar 2025.
- Derived from this study: PubMed 41310279Kent EE, Deal AM, Sperry SS, Nakamura ZM, Gellin M, Kovacs J, Martin C, Reblin M. Feasibility and Acceptability of an 8-Week Supportive Care Intervention for Cancer Caregivers Adapted for Rural Settings. Psychooncology. 2025 Dec;34(12):e70341. doi: 10.1002/pon.70341.
- Derived from this study: PubMed 39234997Kent EE, Tan KR, Nakamura ZM, Kovacs J, Gellin M, Deal A, Park EM, Reblin M. Building on and tailoring to: Adapting a cancer caregiver psychoeducational intervention for rural settings. Cancer Med. 2024 Sep;13(17):e70187. doi: 10.1002/cam4.70187.
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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.
Erin E Kent, PhD, MS principal investigator
Department of Health Policy and Management Gillings School of Global Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eco-mapping tool and Caregiver-coach study visits in people with Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 12 inclusion and 6 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 30 Mar 2025. 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. 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?
Study feasibility - caregiver enrollment (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT05828927, which also lists 2 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 30 Mar 2025.