UNC Lineberger
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT05828927
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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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.
Inclusion criteria
for subjects with cancer In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Exclusion criteria
Exclusion criteria
for caregivers
Exclusion criteria
for subjects 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.
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.
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.
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.
Time frame: 4 weeks, 8 weeks
Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
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'.
UNC Lineberger Comprehensive Cancer Center
Other
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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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