Caregiver Support for Cancer

(CARE Trial)

Overseen By Lilian J. Shin-Cho, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Life expectancy <6 months, Physical limitations, Major thought disorder

Compensation: Varies

Number of Visits: 4

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Asian American cancer patients reduce the stress experienced by their caregivers. It examines how engaging in positive activities can enhance caregivers' sense of independence, skill, and connection. Participants will either perform household tasks to support their caregivers or engage in good deeds outside the home to determine which approach is more beneficial. Individuals who identify as Asian American or Asian, have received a cancer diagnosis within the last year, and are actively receiving treatment may be suitable candidates, especially if they frequently see a caregiver. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance caregiver support and improve quality of life.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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

Research has shown that supporting caregivers can have positive effects without major safety concerns. A review of 49 studies found that activities for caregivers usually improved their well-being within 1 to 3 months, indicating these activities are generally safe and well-tolerated.

In this trial, the treatment includes simple tasks to support caregivers, such as cooking a meal or picking up litter. These everyday activities do not have known health risks. The main goal is to enhance emotional and social well-being, which typically does not cause negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to improving caregiver well-being through active contributions, a perspective often overlooked in standard care practices. Unlike typical support methods that focus on emotional or psychological counseling, this trial encourages participants to engage in tangible actions, either at home or in their community, which can directly impact their caregiver's quality of life. By promoting activities like cooking a meal or picking up litter, the trial aims to foster a sense of purpose and connection, potentially leading to enhanced well-being for both caregivers and participants.

What evidence suggests that this trial's treatments could be effective for caregiver support in cancer?

This trial will compare a contribution-based support program with a control group to assess its impact on caregiver wellbeing. Studies have shown that helping caregivers can improve their wellbeing. For example, research examining several trials found that these types of support led to better outcomes for caregivers within 1-3 months. When caregivers feel better, they can provide better support to cancer patients. Additionally, caregivers often have unmet needs, which can hinder their ability to care for others. By helping caregivers feel more capable, connected, and independent, support programs like the one under study can reduce their stress and improve their overall health. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for Asian American individuals with tumors who want to help reduce the perceived burden on their caregivers. Specific eligibility criteria are not provided, but typically participants would need to meet certain health and demographic requirements.

Inclusion Criteria

Patients self-identifying as Asian American or Asian

I was diagnosed with cancer or stage 4 cancer within the last year.

I am currently receiving or have received cancer treatment in the last 6 months.

Exclusion Criteria

I cannot walk or stand on my own due to physical limitations.

Life expectancy less than 6 months in the opinion of the primary physician

Major thought disorder (e.g., schizophrenia or bipolar [patient records or self-disclosure])

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in positive activities designed to increase autonomy, competence, and connectedness

4 weeks

Baseline, midpoint, and end of intervention assessments

Follow-up

Participants are monitored for psychological and interpersonal well-being after the intervention

4 weeks

Follow-up assessment 4 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Contribution to Caregivers Well-Being

Trial Overview The CARE Study is testing a positive activity intervention aimed at enhancing autonomy, competence, and connectedness in patients to alleviate caregiver burden. It's unclear if there's a control group or how participants will be compared.

How Is the Trial Designed?

Group I: Contribution Experimental Treatment 1 Intervention

Contribution to caregiver wellbeing via household tasks. If the household contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the well-being of their caregiver (e.g., cook a meal, take pet for a walk, water the plants). If the outside contribution condition is chosen, participants will be given instructions and examples/list of things they could do to contribute to the world outside of their own home (e.g., pick up litter in neighborhood, buy coffee for stranger, donate food/clothing to homeless)

Group II: Control Group Placebo Group 1 Intervention

Participants in the control group will be asked to factually describe either (1) immediate environment, (2) the weather, or (3) organization of closet

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A 16-week nursing intervention aimed at supporting caregivers of newly diagnosed cancer patients did not significantly reduce caregiver depression levels, but it may have slowed the deterioration of depressive symptoms over time.

Caregivers with higher baseline depression were more likely to withdraw from the study, making it challenging to assess the full impact of the intervention on caregiver mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving depressive symptoms among caregivers of patients with cancer: results of a randomized clinical trial. Kozachik, SL., Given, CW., Given, BA., et al.[2022]

The 'Buddy Study' program, which includes a seminar and peer support for healthcare professionals after adverse events, received positive feedback from participants, with 91.6% satisfied with the seminar content and 69.1% feeling it helped them manage their emotional responses.

The program fostered a compassionate culture and attentiveness to colleagues' wellbeing, although it highlighted the need for ongoing support and visibility to maintain its effectiveness, suggesting that while valuable, peer support should complement other forms of support rather than replace them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of'the Buddy Study', a peer support program for second victims in healthcare: a survey in two Danish hospital departments. Schrøder, K., Bovil, T., Jørgensen, JS., et al.[2022]

A new assignment for specialist oncology nurses on adverse drug reaction (ADR) reporting resulted in 97% of the 33 reported ADRs being well documented, demonstrating the nurses' capability in pharmacovigilance.

The majority of nurses found the assignment useful and reported that it increased their awareness of medication safety, with 84% stating it changed how they managed ADRs in their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study. Schutte, T., van Eekeren, R., Richir, M., et al.[2019]

The CancerSupportSource-Caregiver is a newly refined 18-item screening tool designed to effectively assess distress among cancer caregivers, covering five key areas of concern including emotional well-being and caregiving tasks, based on a study involving 400 caregivers.

This tool demonstrated strong reliability and validity, with high sensitivity for detecting depression (95%) and anxiety (87%), making it a valuable resource for identifying caregivers' unmet needs and improving their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CancerSupportSourceTM -Caregiver: Development of a distress screening measure for cancer caregivers. Zaleta, AK., Miller, MF., Fortune, EE., et al.[2023]

Psychosocial interventions for informal caregivers of cancer patients may slightly improve caregiver quality of life immediately after the intervention, but show little to no long-term effects or impact on caregiver depression and anxiety, based on a review of 19 trials involving 3,725 participants.

The studies reviewed had high risk of bias and significant variability in intervention types, making it challenging to determine the overall effectiveness of these interventions; thus, more rigorous and detailed future research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for informal caregivers of people living with cancer. Treanor, CJ., Santin, O., Prue, G., et al.[2022]

A study involving 78 participants, including caregivers, patients, and healthcare providers, revealed differing opinions on whether caregiver-reported outcomes should be shared with patients, highlighting the complexity of communication in cancer care.

Healthcare providers identified strategies to balance the need for open communication with caregivers and patients while also considering the potential emotional burden that sharing these assessments might impose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To share or not to share: communication of caregiver-reported outcomes when a patient has colorectal cancer. Howard, AF., Torrejón, MJ., Lynch, K., et al.[2023]

Supportive interventions like psychoeducation and skills training can significantly improve the well-being and quality of life for informal caregivers of cancer patients, addressing their physical and psychological needs.

Despite the evidence supporting these interventions, challenges remain in implementing them effectively in practice due to mismatches with caregiver needs, lack of trained teams, and insufficient funding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and Supporting Informal Cancer Caregivers. Molassiotis, A., Wang, M.[2022]

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]

The Caregiver Quality of Life Index-Cancer (CQOLC) is a reliable and valid tool for assessing the quality of life of family caregivers, showing high test-retest reliability (0.95) and internal consistency (0.91) based on a study of 263 caregivers of cancer patients.

The study found that better overall mental health is linked to improved quality of life for caregivers, while higher emotional distress and poorer patient performance status negatively impact their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer. Weitzner, MA., Jacobsen, PB., Wagner, H., et al.[2022]

A 2-year study involving 88 specialist oncology nurses (SONs) showed that an educational intervention on pharmacovigilance significantly increased the reporting of adverse drug reactions (ADRs), with the intervention group reporting 82 ADRs compared to none from the control group.

The intervention made SONs 105 times more likely to report ADRs than the average nurse in the Netherlands, demonstrating that targeted education can effectively enhance ADR reporting and improve pharmacovigilance competence in healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions. Reumerman, M., Tichelaar, J., van Eekeren, R., et al.[2022]

A structured 4-week intervention for caregivers of patients with newly diagnosed advanced cancer led to significant improvements in specific quality of life (QOL) domains, such as spiritual well-being and mood, measured at 4 weeks post-intervention.

Long-term benefits were observed at 27 weeks, with caregivers maintaining improvements in fatigue and financial concerns, suggesting that while the intervention was effective, more tailored approaches may be needed for overall QOL enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer caregiver quality of life: need for targeted intervention. Lapid, MI., Atherton, PJ., Kung, S., et al.[2018]

A study of 96 caregivers of cancer patients in Brazil found that certain sociodemographic factors, such as being separated, a mother, or the sole caregiver, are linked to lower wellness levels.

Caregivers with higher education, lower family income, and existing health problems also reported reduced wellness, highlighting the need for targeted support strategies from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between wellness and sociodemographic characteristics of caregivers of people with cancer. Tiago de Oliveira, W., Misue Matsuda, L., Aparecida Sales, M.[2018]

Cancer patients and their caregivers actively engage in various behaviors to promote safety and resilience in their treatment journey, including physical care, communication, and care coordination, as highlighted in a scoping review of 16 studies.

The review emphasizes that patients and caregivers are crucial assets in the healthcare system, yet they often feel unsupported, indicating a need for further research to address the gaps in their involvement and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Do Patients and Their Carers Do to Support the Safety of Cancer Treatment and Care? A Scoping Review. Tillbrook, D., Absolom, K., Sheard, L., et al.[2023]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

Caregiver well-being significantly impacts the quality of cancer care, affecting not only the care provided by healthcare teams but also the support caregivers give and how patients manage their own health.

Nurses play a crucial role in enhancing caregiver support, which can lead to improved patient outcomes in cancer care, highlighting the importance of psychosocial care in nursing practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Well-being and the Quality of Cancer Care. Litzelman, K.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6728914/

Caregiver Well-being and the Quality of Cancer Care - PMC Caregivers who are in good physical and emotional health are likely best able to provide practical, emotional, and self-management support to the cancer patient ...

2. cancer.gov cancer.gov/about-cancer/coping/family-friends/family-caregivers-hp-pdq

Informal Caregivers in Cancer (PDQ®) - NCI They found that 64% of caregivers had at least one significant unmet need, 53% had three or more unmet needs, and 29% had ten or more unmet ...

3. academic.oup.com academic.oup.com/jnci/article/115/8/896/7188112

Interventions to improve outcomes for caregivers of patients ... In this systematic review and meta-analysis of 49 randomized controlled trials, interventions for caregivers resulted in improvements at 1-3 months in caregiver ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0885392425005780

Impact of Caregiver and Patient Age on Efficacy ... It has been shown that interventions to support caregivers of patients with advanced cancer improve caregiver wellbeing, but the possible additional ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2810486

Availability of Family Caregiver Programs in US Cancer ... Cancer caregivers can provide up to an average of 8 hours of daily assistance to care recipients, including managing and monitoring symptoms, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2950247025000325

Unseen burden: Exploring caregiver experiences, barriers, ... Caregivers play a pivotal role in supporting foregut cancer patients, yet their experiences and the challenges they face are overlooked.

7. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1334842/full

Caregiving consequences in cancer family caregivers The findings of this review demonstrate that caring for a family member with cancer has significant implications for caregivers.