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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

Must not have

No chronic steroid medication use (caregiver)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I can fully participate in the assigned virtual program.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not take chronic steroid medications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Caregiver: Change in Adrenal Activity Over Time

Caregiver: Change in Caregiver Telomere Length Over Time

Caregiver: Change in Perceived Stress Scale (PSS)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

PEPRR

2008

Completed Phase 3

~300

Pep-Pal

2016