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Completed

NCT Number: NCT05828927

enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Lineberger

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Eco-mapping tool

Behavioral

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 visits

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Intervention acceptability-quantitative

    Time frame: 4 weeks, 8 weeks

    Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.

  3. 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'.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • The Duke Endowment

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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