CancerenCompassNCT07061652
Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes
A study testing Survey and the resource booklet from the American Cancer Society in people with Cancer and Diabetes, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- What is being tested?
- Survey and the resource booklet from the American Cancer Society
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jul 2025to 27 Jan 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking.
- Ability to provide written or verbal informed consent to participate in the study;
- Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;
- Be at least 18 years of age at the time of consent; and
- Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.
- English-speaking
Show all 14Show fewer
- Ability to provide informed consent.
- Be at least 18 years of age at the time of consent; and
- Their identified caregiver is enrolled in the study
- Diagnoses: (must have cancer and diabetes)
- Have a cancer diagnosis for which they are being actively treated at one of the study sites
- Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy
- Receiving active cancer treatment s, not including hormonal therapy
- Concurrent history of diabetes with need for ongoing management
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 other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;
- Participation in the intervention development phase of this intervention
- Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- Existence of other 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
3 sites in 1 country.
United States3 sites
University of Vermont Cancer Center
Burlington, Vermont, 05401
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program.
Caregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers.
Read more
Caregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs.
Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications.
- Being tested
- Survey, the resource booklet from the American Cancer Society
- Keywords
- support application, caregivers
- Medical subject headings
- Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Participants will receive up to eight coaching sessions with a caregiver coach and resource materials and access to an online tool designed to help caregivers find resources.
the resource booklet from the American Cancer SocietyOther
The caregiver will receive the resource booklet from the American Cancer Society.
| Study group | Role | What they receive |
|---|---|---|
| caregivers | Experimental | Caregivers of patients with cancer and comorbid diabetes will receive the intervention, enCompass contains two components: (1) an web-based eco-mapping tool that encourages the cognitive process of identifying, organizing, and visualizing a person's social network, and (2) a manualized, one-to-one 8-week coaching intervention to develop problem-solving skills for specific support needs.
Caregivers will also receive a resource booklet from the American Cancer Society. Receives: Behavioral: Survey |
| caregiver | Active comparator | Caregivers of patients with cancer and comorbid diabetes will not receive the intervention. Receives: Other: the resource booklet from the American Cancer Society |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the Intervention Measure (AIM)
The AIM is a 4-item, 5-point Likert scale that measures intervention acceptability. The scale measures each statement from 1, "Completely disagree," to 5, "Completely agree." Scale items are averaged to produce a mean score. The AIM takes approximately 2 minutes to complete by caregivers.
Measured: 8 weeks
Secondary outcomes (8)
Coping Self-Efficacy Scale (CSES)
The Coping Self-Efficacy Scale is a 26-item, 10-point ordinal scale that measures caregiver coping and self-efficacy ability. Subjects are asked to self-score their confidence in each prompt on a scale from 0 (Cannot do at all) to 10 (Certain I can do).
An overall CSES score is created by summing the item ratings (total score range, 0 - 260), with higher scores indicating greater perceived coping self-efficacy. Subjects must answer at least 80% of the scale items. For subjects missing an item or items, an individual's score for the missing item(s) is estimated by adding in their mean for the items that they answered for each item that they skipped, resulting in a "corrected sum." This measure will take approximately 7 - 10 minutes to complete by caregivers.
Measured: Baseline, 8 weeks, 6 months
Zarit Burden Assessment - Revised
The Zarit Burden Assessment - Revised is a commonly used, 12-item self-report scale measuring caregiver burden. The Zarit Burden Assessment-Revised has excellent internal consistency (Cronbach's alpha typically ranges from 0.83 to 0.89) and test-retest reliability (typically around 0.71). The measure typically takes 5-10 minutes to completeby caregivers.
Measured: Baseline, 8 weeks, 6 months
Duke-UNC Functional Support Questionnaire (FSSQ)
The Duke-UNC FSSQ is an 8-item, multidimensional scale measuring perceived social support. Response items are scored from 5 ("as much as I would like") to 1 ("much less than I would like"). The scores from all eight questions are summed for a total score range of 8 to 40, with higher scores indicating higher perceived support. The Duke-UNC FSSQ has demonstrated high reliability and convergent validity. This measure will take approximately 3-5 minutes to complete by caregivers.
Measured: Baseline, 8 weeks, 6 months
Hospital Anxiety and Depression Scale (HADS) - Caregivers
The HADS is a 14-item, 4-point, self-report ordinal scale that measures depression and anxiety symptom severity. It is a well-validated and commonly used measure in both ill and healthy populations. It has two sub-scales, each with a total score range of 0 - 21, with higher scores suggesting more symptoms. Current research supports a threshold of 8 or higher as indicative of clinically significant depression or anxiety symptoms. The HADS takes approximately 3-5 minutes to complete by caregivers.
Measured: Baseline, 8 weeks, 6 months
Exit interview for Acceptability
A subset of caregiver subjects will be asked to participate in a post-intervention, semi-structured, exit interview to further evaluate intervention acceptability.
Measured: 6 months
Karnovsky Performance Score
The Karnovsky Performance Scale measures the functional status as it relates to cancer. The patient subject will self-report their current performance status by assessing a single item on an 8-point scale. The Karnovsky Scale takes approximately 2 minutes to complete.
Measured: Baseline, 8 weeks, 6 months
NCCN Distress Thermometer
The NCCN Distress Thermometer is a tool developed by the National Comprehensive Cancer Network (NCCN) to help healthcare providers assess and manage distress in cancer patients.
The single-item, 11-point NCCN Distress Thermometer asks subjects to rank their current level of distress on a scale from 0 (no distress) to 10 (extreme distress). This measure takes approximately 2 minutes to complete by patients.
Measured: Baseline, 8 weeks, 6 months
Hospital Anxiety and Depression Scale (HADS) - Patients
The HADS is a 14-item, 4-point, self-report ordinal scale that measures depression and anxiety symptom severity. It is a well-validated and commonly used measure in both ill and healthy populations. It has two sub-scales, each with a total score range of 0 - 21, with higher scores suggesting more symptoms. Current research supports a threshold of 8 or higher as indicative of clinically significant depression or anxiety symptoms in patient participants. The HADS takes approximately 3-5 minutes to complete by patients.
Measured: Baseline, 8 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start3 Jul 2025
- Primary completion16 Sep 2026
- Study completion27 Jan 2027 (estimated)
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Humana Foundation
- Responsible party
- Sponsor
- Investigators
- Erin E Kent, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061652
- Sponsor's protocol ID
- LCCC2453
- Acronym
- enCompass
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes
- ClinicalTrials.gov ID
- NCT07061652
- Acronym / sponsor ID
- enCompass / LCCC2453
- Keywords
- support application, caregivers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Humana Foundation
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 11 Jul 2025 (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 investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program.
Caregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers.
Caregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs.
Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caregivers | Experimental | Behavioral: SurveyCaregivers of patients with cancer and comorbid diabetes will receive the intervention, enCompass contains two components: (1) an web-based eco-mapping tool that encourages the cognitive process of identifying, organizing, and visualizing a person's social network, and (2) a manualized, one-to-one 8-week coaching intervention to develop problem-solving skills for specific support needs. Caregivers will also receive a resource booklet from the American Cancer Society. |
| caregiver | Active comparator | Other: the resource booklet from the American Cancer SocietyCaregivers of patients with cancer and comorbid diabetes will not receive the intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- English-speaking.
- Ability to provide written or verbal informed consent to participate in the study;
- Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;
- Be at least 18 years of age at the time of consent; and
- Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.
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 other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;
- Participation in the intervention development phase of this intervention
- Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- Existence of other 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 |
|---|---|---|
| SurveyParticipants will receive up to eight coaching sessions with a caregiver coach and resource materials and access to an online tool designed to help caregivers find resources. | Behavioural | caregivers |
| the resource booklet from the American Cancer SocietyThe caregiver will receive the resource booklet from the American Cancer Society. | Other | caregiver |
Primary outcome
Acceptability of the Intervention Measure (AIM)
Time frame: 8 weeks
The AIM is a 4-item, 5-point Likert scale that measures intervention acceptability. The scale measures each statement from 1, "Completely disagree," to 5, "Completely agree." Scale items are averaged to produce a mean score. The AIM takes approximately 2 minutes to complete by caregivers.
8 secondary outcomes
Coping Self-Efficacy Scale (CSES)
Time frame: Baseline, 8 weeks, 6 months
Zarit Burden Assessment - Revised
Time frame: Baseline, 8 weeks, 6 months
Duke-UNC Functional Support Questionnaire (FSSQ)
Time frame: Baseline, 8 weeks, 6 months
Hospital Anxiety and Depression Scale (HADS) - Caregivers
Time frame: Baseline, 8 weeks, 6 months
Exit interview for Acceptability
Time frame: 6 months
Karnovsky Performance Score
Time frame: Baseline, 8 weeks, 6 months
NCCN Distress Thermometer
Time frame: Baseline, 8 weeks, 6 months
Hospital Anxiety and Depression Scale (HADS) - Patients
Time frame: Baseline, 8 weeks, 6 months
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 14 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 principal investigator
UNC Lineberger Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey and the resource booklet from the American Cancer Society in people with Cancer and Diabetes, run by UNC Lineberger Comprehensive Cancer Center at 3 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?
The sponsor lists 14 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Acceptability of the Intervention Measure (AIM) (time frame: 8 weeks). 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 14 Oct 2026.