- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828927
enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jesse Kovacs
- Phone Number: 919-962-5356
- Email: encompasscarolina@unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- UNC Lineberger
-
Contact:
- Jesse Kovacs
- Phone Number: 919-962-5356
- Email: encompasscarolina@unc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
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.
- 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.
Exclusion Criteria
Exclusion criteria for caregivers
- 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.
Exclusion criteria for subjects with cancer
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Caregiver of subject with cancer
Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.
|
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
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.
|
No Intervention: Subject with Cancer
Subjects is with cancer and receive care from caregivers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability-qualitative
Time Frame: 4 weeks, 8 weeks
|
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. |
4 weeks, 8 weeks
|
Intervention acceptability-quantitative
Time Frame: 4 weeks, 8 weeks
|
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
|
4 weeks, 8 weeks
|
Caregiver self-efficacy
Time Frame: Baseline, 4 weeks, 8 weeks
|
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'. |
Baseline, 4 weeks, 8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Erin E Kent, PhD, MS, Department of Health Policy and Management Gillings School of Global Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LCCC2242
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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