Social Support Intervention for Cancer Caregivers

Overseen By Jesse Kovacs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Illiteracy, Neurologic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called enCompass Carolina, designed to support caregivers of cancer patients in rural areas. The goal is to assess the usefulness and effectiveness of this social support program for caregivers who may feel isolated from healthcare resources. The study seeks unpaid caregivers who assist someone with cancer, especially those living in rural areas. The trial will gather feedback to improve how caregivers find and use support networks. As an unphased trial, it offers caregivers an opportunity to contribute to developing vital support systems that can enhance their caregiving experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social support rather than medication changes.

What prior data suggests that this social support intervention is safe for cancer caregivers?

Research has shown that enCompass Carolina, a support program for cancer caregivers, is safe because it emphasizes coaching and support over medical treatment. Studies have evaluated its effectiveness and acceptability, aiming to provide caregivers with guidance and resources. No reports of problems or safety issues have emerged, as the program is non-invasive and centers on emotional and practical support. Without medical procedures involved, participants can expect a low-risk experience designed to enhance their caregiving journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Social Support Intervention for Cancer Caregivers because it emphasizes a unique approach to supporting caregivers, which is often overlooked in traditional cancer care. Unlike standard treatments that primarily focus on the patient, this intervention targets the well-being of caregivers, providing them with essential social support and resources. This approach aims to improve the caregivers' mental health and resilience, ultimately benefiting both the caregiver and the person with cancer. By focusing on rural-dwelling caregivers, the intervention also addresses a gap in care accessibility, tailoring support to those who might otherwise be isolated from such resources.

What evidence suggests that the enCompass Carolina intervention is effective for cancer caregivers?

Research shows that the enCompass Carolina program, studied in this trial, aims to help caregivers of cancer patients by connecting them with new support resources. Early results suggest that programs like enCompass can improve caregivers' well-being. The program specifically seeks to reduce stress and increase access to resources for those in rural areas, where support options may be limited. It builds on previous successful programs and shows promise in helping caregivers manage their duties more effectively. While detailed data on enCompass Carolina's effectiveness is still being collected, its approach relies on proven models that have helped caregivers in similar situations. ^{1 2 3 6 7}

Who Is on the Research Team?

Erin E Kent, PhD, MS

Principal Investigator

Department of Health Policy and Management Gillings School of Global Public Health

Are You a Good Fit for This Trial?

This trial is for caregivers of cancer patients with stage II-IV solid tumors or hematologic malignancies, who are receiving active treatment and live in rural areas. Caregivers must be adults, speak English, provide consent, and commit to the study's procedures. Patients' caregivers must also enroll in the study.

Inclusion Criteria

Caregivers: Ability to provide written or electronic informed consent to participate in the study

Subjects with Cancer: Caregiver is enrolled in the study

I am a caregiver and I speak English.

Exclusion Criteria

Caregivers: Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes

Caregivers: Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol

Subjects with Cancer: Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers participate in the enCompass Carolina social support intervention

8 weeks

At least 1 intervention visit

Follow-up

Participants are monitored for feedback and effectiveness of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• enCompass Carolina

Trial Overview The enCompass Carolina program is being tested for its ability to help cancer caregivers find new support sources. It includes using an eco-mapping tool and caregiver-coach visits to assess if this social support intervention is feasible and effective in rural communities.

How Is the Trial Designed?

Group I: Caregiver of subject with cancer Experimental Treatment 2 Interventions

Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.

Group II: Subject with Cancer Active Control 1 Intervention

Subjects is with cancer and receive care from caregivers.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+

Published Research Related to This Trial

An eight-session stress management intervention for caregivers of allogeneic hematopoietic stem cell transplant recipients was effective in reducing distress, with 70% of the 74 participants completing all sessions, indicating good acceptability.

Challenges included low usage of a biofeedback device and high dropout rates due to patient illness or death, suggesting that future interventions may benefit from more flexible delivery methods like phone or video sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based stress management intervention for allogeneic hematopoietic stem cell transplant caregivers: development, feasibility and acceptability. Simoneau, TL., Kilbourn, K., Spradley, J., et al.[2018]

A web-based communication program for cancer patients and their caregivers was successfully adapted from an in-person intervention, showing high usability and acceptability among users, including those with limited computer experience.

The program received a mean System Usability Score of 89.5 out of 100, indicating it was easy to use and well-received, highlighting the effectiveness of a multidisciplinary approach in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting an in-person patient-caregiver communication intervention to a tailored web-based format. Zulman, DM., Schafenacker, A., Barr, KL., et al.[2021]

A study of 90 family caregivers providing in-home hospice care for cancer patients identified three distinct patterns of support and stress in their social networks, highlighting the complexity of caregiver experiences.

Caregivers who received high support but also experienced high stress (the 'ambivalent maximizers' class) reported greater burden compared to those who felt supported with low stress, indicating that not all support is beneficial and that understanding these dynamics is crucial for managing caregiver burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of stress and support in social support networks of in-home hospice cancer family caregivers. Guo, JW., Reblin, M., Tay, D., et al.[2021]

The Abrazo intervention significantly improved cancer knowledge and self-efficacy among both cancer survivors (n = 37) and their informal caregivers (cosurvivors, n = 103), indicating its effectiveness as a psychoeducational tool.

While cosurvivors experienced a decrease in distress levels after the intervention, cancer survivors showed an increase in distress, highlighting the need for targeted support for their unique challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Un Abrazo Para La FamiliaTM in southern Arizona with extension to survivors and assessment of effects on distress. Marshall, CA., Trejo, MJ., Trejo, JI., et al.[2021]

The electronic psychosocial screening program successfully reached 95.5% of caregivers of pediatric oncology patients, allowing for timely identification of distress, with 16.9% of caregivers reporting high distress levels.

When caregivers reported high distress, medical teams effectively referred them to social work support 95.5% of the time, highlighting the program's efficacy in providing necessary psychosocial support at the point of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Electronic Psychosocial Screening Among Caregivers in Pediatric Oncology. Manikowski, A., Williamson Lewis, R., Bennett, T., et al.[2022]

A study involving 484 patient-caregiver dyads found that both brief (three-session) and extensive (six-session) interventions improved coping, self-efficacy, and quality of life (QOL) for patients and caregivers, particularly in social and emotional aspects.

Most positive effects were observed at the three-month mark, indicating that while the interventions were beneficial, the improvements may not be sustained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Northouse, LL., Mood, DW., Schafenacker, A., et al.[2022]

The review analyzed 51 articles on social support for families of cancer patients, revealing that 70% of the studies were quantitative and nearly half were authored by nurses, highlighting the nursing role in providing social support.

Key themes included the role of family caregivers, factors that hinder social support, and the impact of religiosity and educational programs, indicating a need for targeted interventions to enhance support for families during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Social support to the family of the cancer patient: identifying ways and directions]. Sanchez, Kde O., Ferreira, NM., Dupas, G., et al.[2019]

About two-thirds of informal cancer caregivers reported using social resources, with faith-based groups and social clubs being the most common, while formal resources like counseling and support groups were used by only a small fraction of caregivers.

Social resource use among caregivers increased over time after the patient's cancer diagnosis, suggesting that interventions to promote social support could be more effective if timed appropriately, especially around 9 to 10 months post-diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of social resource use among informal lung cancer caregivers. Litzelman, K., Reblin, M., McDowell, HE., et al.[2021]

Social support during cancer treatment significantly enhances the quality of life, hope, and resilience for both patients and their informal caregivers, as highlighted in a review of 13 studies involving adult cancer patients.

Despite the positive associations found, many support interventions were not well-evaluated, and the studies often had small sample sizes, indicating a need for more robust research to inform best practices in supporting patient-caregiver relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support in a Cancer Patient-Informal Caregiver Dyad: A Scoping Review. Pasek, M., Goździalska, A., Jochymek, M., et al.[2023]

The DIAdIC study will evaluate the effectiveness of two psychosocial interventions for 936 patient-family caregiver dyads across six European countries, aiming to improve emotional functioning and self-efficacy in advanced cancer care.

The interventions, a nurse-led face-to-face program and a web-based program, are designed to empower both patients and caregivers, potentially leading to better quality of life and reduced healthcare resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial. Matthys, O., De Vleminck, A., Dierickx, S., et al.[2022]

The Internet-based intervention (IBI) called OAse was found to be feasible for family caregivers of cancer patients, with a recruitment rate of 47% and a retention rate of 68%, indicating that caregivers are willing to engage with this type of support.

Participants reported a high satisfaction rate of 96%, and while there were no significant changes in emotional state or self-efficacy, there were trends suggesting potential improvements in managing difficult emotions and reducing anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of a self-guided internet-based intervention for family caregivers of patients with cancer (OAse). Grapp, M., Ell, J., Kiermeier, S., et al.[2022]

Caregivers of cancer patients often experience significant emotional strain, which can negatively impact both their health and the outcomes for the patients they care for, highlighting the need for effective support services.

Three evidence-based programs—the FOCUS Program, the Program for the Study of Cancer Caregivers at MSKCC, and CancerSupportSource®-Caregiver—have been developed to address the needs of these caregivers, demonstrating various effective approaches to provide necessary psychosocial support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing informal caregiver burden in cancer: evidence-based programs in practice. Longacre, ML., Applebaum, AJ., Buzaglo, JS., et al.[2020]

A new support intervention for caregivers of brain tumor patients was developed, utilizing a caregiver navigator to help them access social support and formal services, which is crucial given the unmet needs of these caregivers.

Preliminary data from the first 15 participants indicate high satisfaction and perceived helpfulness of the intervention, suggesting that caregiver navigation could be an effective model for future support programs in neuro-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing a critical need for caregiver support in neuro-oncology: development of a caregiver navigation intervention using eSNAP social resource visualization. Reblin, M., Wells, KJ., Otto, A., et al.[2022]

Citations

1. researchforme.unc.edu researchforme.unc.edu/study-details?rcid=4413

A social support and coaching program for cancer caregivers The purpose of this study is to assess the acceptability and preliminary effect of enCompass Carolina, a social support program for caregivers of rural-dwelling ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07061652

Expanding the Support of Family Caregivers of Diverse ... The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program.

3. withpower.com withpower.com/trial/phase-malignancies-3-2023-4e085

Social Support Intervention for Cancer Caregivers 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11375528/

Building on and tailoring to: Adapting a cancer caregiver ... In this paper, we outline how our team adapted CARING, an intervention designed to support caregivers of neuro‐oncology patients, into enCompass ...

5. unclineberger.org unclineberger.org/unclcn/wp-content/uploads/sites/871/2023/03/20230308-Kent-Muss-HANDOUT-3-UP.pdf

Main Title Coach-assisted program designed to help identify social support needs and connect caregivers to people and resources. • Targeted to rural cancer ...

6. researchforme.unc.edu researchforme.unc.edu/study-details?rcid=3558

enCompass:Navigator-assisted ecomaps to support cancer ... The purpose of this study is to further adapt an evidence-based, social support intervention, enCompass for rural cancer caregivers by identifying the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11042433/

An Environmental Scan and Qualitative Inquiry of Cancer ... We sought to complete a digital environmental scan and qualitative inquiry of cancer patient navigation services throughout the state to better inform patients.