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

Trial Summary

What is the purpose of this trial?

The overarching goal of the current study is to reduce the burden Asian American patients may feel are on their caregivers by designing and testing the feasibility and efficacy of a positive activity intervention designed to increase a sense of autonomy, competence, and connectedness, each of which have been shown to be associated with psychological benefits according to self-determination theory.

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 data supports the effectiveness of the treatment Contribution to Caregivers Well-Being for cancer caregivers?

Research shows that interventions aimed at improving communication and support for cancer caregivers can enhance their emotional well-being and reduce distress in the short term. Additionally, supportive interventions have been shown to improve depressive symptoms among caregivers of cancer patients. ^{1 2 3 4 5}

Is the Caregiver Support for Cancer treatment safe for humans?

The research articles provided do not contain specific safety data for the Caregiver Support for Cancer treatment or its related programs. They focus on adverse drug reaction reporting and safety practices in oncology settings, but not directly on the safety of the caregiver support treatment itself. ^{6 7 8 9 10}

How does the treatment 'Contribution to Caregivers Well-Being' differ from other treatments for cancer caregivers?

The 'Contribution to Caregivers Well-Being' treatment is unique because it focuses on supporting the mental and emotional health of cancer caregivers, addressing their unmet needs through distress screening and linking them to resources. Unlike other treatments that may focus solely on the patient's health, this approach aims to improve the quality of life and well-being of caregivers themselves. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Cancer caregiver quality of life: need for targeted intervention. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Adapting an in-person patient-caregiver communication intervention to a tailored web-based format. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improving depressive symptoms among caregivers of patients with cancer: results of a randomized clinical trial. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

To share or not to share: communication of caregiver-reported outcomes when a patient has colorectal cancer. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

What Do Patients and Their Carers Do to Support the Safety of Cancer Treatment and Care? A Scoping Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England 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. [2022]

10. Germany 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. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Understanding and Supporting Informal Cancer Caregivers. [2022]

12. England pubmed.ncbi.nlm.nih.gov

CancerSupportSourceTM -Caregiver: Development of a distress screening measure for cancer caregivers. [2023]

13. Netherlands 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. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for informal caregivers of people living with cancer. [2022]

15. Colombia pubmed.ncbi.nlm.nih.gov

Relationship between wellness and sociodemographic characteristics of caregivers of people with cancer. [2018]