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Virtual Stress Management for Caregiver Stress (eCare Trial)

N/A

Waitlist Available

Led By Cathy J Bradley, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be available to fully participate in an intervention (Virtual-PEPRR or PepPal) if assigned

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 month, 6 month, 9 month, 12 month follow up

Awards & highlights

eCare Trial Summary

This trial will see if a stress management program can help caregivers of cancer patients who are under a lot of stress. It is expected that this will help reduce depressive symptoms in caregivers.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like stress management programs, there aren't typical side effects as seen with drugs; however, participants may experience emotional discomfort while discussing personal issues.

eCare Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can fully participate in the assigned virtual program.

eCare Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 month, 6 month, 9 month, 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 month, 6 month, 9 month, 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 6 month, 9 month, 12 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD)

Secondary outcome measures

Caregiver: Change in Adrenal Activity Over Time

Caregiver: Change in Caregiver Telomere Length Over Time

Caregiver: Change in Perceived Stress Scale (PSS)

+9 more

eCare Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Caregiver Self-DirectedExperimental Treatment1 Intervention

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

Group II: Caregiver InterventionExperimental Treatment1 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 ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pep-Pal

2016

N/A

~70

PEPRR

2008

Completed Phase 3

~300

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,038 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,643 Total Patients Enrolled

Cathy J Bradley, PhDPrincipal InvestigatorUniversity of Colorado Denver (Anschutz Medical Campus)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria for this trial limited to individuals younger than sixty?

"This study is accepting candidates aged 18 to 64. For those younger than that, there are 80 other clinical trials available and 2022 for those who exceed the upper limit of 65 years old."

Answered by AI

What qualifications must one possess to partake in this clinical research?

"This trial is enrolling 300 patients with a diagnosis of breast cancer aged 18 to 64 years old. Additionally, these applicants must meet the following criteria: Active employment for more than 20 hours per week prior to diagnosis (those laid off due to Covid-19 are still eligible if actively seeking work), Primary caregiver for patient diagnosed with solid tumor cancer within 12 weeks +/- of beginning treatment consisting of infusion chemo/immunotherapy or oral targeted agents, Spouse or partner in relationship with primary caregiver and patient for at least one year each, Live together, English literacy skills above basic level as assessed by PHQ-2 (dep"

Answered by AI

What is the current enrollment for this research project?

"Affirmative. According to the data on clinicaltrials.gov, this medical trial is currently accepting participants. The study was first advertised on February 5th 2021 and has been revised as recently as June 15th 2022. The research team needs to recruit 300 patients across 2 sites for their experiment."

Answered by AI

Are there any vacancies for participation in this trial?

"Affirmative. Clinicaltrials.gov attests that this research is actively seeking participants, with the original post date of February 5th 2021 and a subsequent update on June 15th 2022. 300 test subjects are needed from 2 different locations for the experiment to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.

2021. "Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04739696.

All > Colon Cancer > Anxiety