Virtual Stress Management for Caregiver Stress

(eCare Trial)

Recruiting at 1 trial location

Overseen By Heather Rouse

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Steroids

Disqualifiers: Serious medical condition, Pregnancy, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 11

Duration: 12 months

510 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate psychological distress and pathophysiology in spousal or partnered caregivers of patients' diagnosis with a solid tumor cancer of any stage. It is expected that improving caregiver status will have reduced depressive symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using steroid medications chronically, you may not be eligible to participate.

What data supports the effectiveness of the treatment Pep-Pal, PEPRR for managing caregiver stress?

Research shows that Pep-Pal, a mobile intervention, helps caregivers of cancer patients reduce anxiety, depression, and stress. Additionally, internet-based interventions have been found effective in decreasing caregiver stress, improving their quality of life and the care they provide. ^{1 2 3 4 5}

Is the Virtual Stress Management program safe for caregivers?

The Virtual Stress Management program, which includes tools like animatronic pets and aromatherapy, is described as simple, safe, and easy-to-use for managing stress at home. ^{2 6 7 8 9}

How is the treatment Pep-Pal, PEPRR different from other treatments for caregiver stress?

Pep-Pal, PEPRR is unique because it is a virtual stress management program specifically designed for caregivers, utilizing internet-based interventions to reduce stress. This approach is novel as it leverages technology to provide support and resources, which are often lacking for home-based caregivers, making it more accessible and convenient compared to traditional in-person methods. ^{2 5 6 8 10}

Research Team

Cathy J Bradley, PhD

Principal Investigator

University of Colorado Denver (Anschutz Medical Campus)

Eligibility Criteria

This trial is for spouses or partners who have been caregivers for at least a year to someone with any stage of solid tumor cancer and are starting treatment. Caregivers must live with the patient, work at least 20 hours per week, be willing to use a smartphone, and show signs of depression or anxiety.

Inclusion Criteria

Able to read and speak the English language

I am willing to use a Smartphone.

A primary caregiver for the patient with a diagnosis of solid tumor cancer

Exclusion Criteria

You have not had a mental illness in the past year and a half that is not related to your role as a caregiver.

I do not take chronic steroid medications.

I don't have a serious illness that could affect my hormone levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers participate in stress management interventions, including Virtual-PEPRR or Pep-Pal, or receive treatment as usual (TAU).

12 months

8 sessions (Virtual-PEPRR), 11 modules (Pep-Pal)

Follow-up

Participants are monitored for psychological and physiological outcomes, including assessments and biomarker collection.

12 months

Assessments at baseline, 3, 6, 9, and 12 months

Treatment Details

Interventions

• Pep-Pal
• PEPRR

Trial Overview The study tests two virtual stress management programs: Pep-Pal and PEPRR. It aims to see if these can reduce psychological distress in caregivers of solid tumor cancer patients by providing psychoeducation tailored for employed individuals.

Participant Groups

Group I: Caregiver Self-Directed Experimental Treatment 1 Intervention

biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention.

Group II: Caregiver Intervention Experimental Treatment 1 Intervention

biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention.

Group III: Caregiver Control Active Control 1 Intervention

biomarker analysis; questionnaire administration; survey administration; treatment as usual

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 24 trials (8 open-label and 16 randomized) found that internet-based interventions can effectively reduce caregiver stress, with 6 out of 16 randomized trials showing positive benefits.

While many interventions were effective, there was no consistent pattern in study variables that predicted better outcomes, indicating a need for further research to optimize these interventions for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. Hu, C., Kung, S., Rummans, TA., et al.[2022]

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]

The study successfully adapted an in-person stress management intervention for caregivers of cancer patients into a mobile-friendly format called Pep-Pal, which consists of 9 sessions focused on various stress management topics.

Feedback from caregivers and palliative care experts indicated that Pep-Pal was acceptable and user-friendly, suggesting it could effectively reach and support caregivers in managing their stress and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups Pensak, NA., Joshi, T., Simoneau, T., et al.[2020]

Home-based caregivers of individuals with dementia experience significant stress primarily due to challenges in medication management, memory loss, hygiene care, and disruptive behaviors, highlighting the need for targeted support.

Professional caregivers have better access to resources and technology, which could be beneficial if adapted for home-based caregivers, but any new technology must be designed with a focus on the human experience to effectively support both caregivers and those with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress in the Volunteer Caregiver: Human-Centric Technology Can Support Both Caregivers and People with Dementia. Huelat, B., Pochron, ST.[2021]

The study aims to develop and test a user-friendly stress management toolkit for people living with dementia and their care partners, using simple, nonpharmacologic tools like animatronic pets and aromatherapy, to help manage stress effectively.

By employing a human-centered design approach and involving dementia caring dyads in the co-design process, the intervention is expected to be more acceptable and feasible for real-world use, with preliminary data supporting its potential for implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. Harris, M., Van Houtven, C., Hastings, S.[2022]

The iCare Stress Management e-Training Program significantly reduced perceived stress among dementia family caregivers compared to an Education/Information-Only condition, indicating its potential efficacy in stress management.

Despite the positive results, the study faced a high dropout rate of about one-third of participants, highlighting the need for strategies to enhance engagement and retention in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. Kajiyama, B., Thompson, LW., Eto-Iwase, T., et al.[2022]

A pilot study involving 23 family caregivers showed that an internet-based psychological intervention significantly reduced care-associated stress, anxiety, and depressive symptoms after treatment.

Participants also experienced a notable increase in self-efficacy, suggesting that this online intervention is effective in helping caregivers manage their psychological stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An internet-based intervention for health promotion in family caregivers--results of a pilot study]. Böttche, M., Klasen, M., Knaevelsrud, C.[2018]

The Baycrest Quick-Response Caregiver ToolTM (BQRCT) was found to be highly feasible and helpful for 21 family caregivers managing neuropsychiatric symptoms of dementia, allowing them to effectively recognize and manage their emotions in real time.

Healthcare providers also found the tool useful, with most recommending it to others, highlighting its potential as a valuable online resource for caregivers who may struggle to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Instrument for Caregivers in Managing Neuropsychiatric Symptoms of Dementia: Baycrest Quick-Response Caregiver ToolTM. Madan, R., Natadiria, M., Berall, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A pilot study of mobilized intervention to help caregivers of oncology patients manage distress. [2022]

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

Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

An evidence-based stress management intervention for allogeneic hematopoietic stem cell transplant caregivers: development, feasibility and acceptability. [2018]

4. Canada pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Stress in the Volunteer Caregiver: Human-Centric Technology Can Support Both Caregivers and People with Dementia. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[An internet-based intervention for health promotion in family caregivers--results of a pilot study]. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

A Novel Instrument for Caregivers in Managing Neuropsychiatric Symptoms of Dementia: Baycrest Quick-Response Caregiver ToolTM. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The Going to Stay at Home program: combining dementia caregiver training and residential respite care. [2019]