Status:
ACTIVE_NOT_RECRUITING
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Lung Cancer
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 s...
Detailed Description
Specific Aims * Evaluate the impact of PsychoEducation Paced Respiration and Relaxation (PEPRR) delivered remotely as Virtual-PEPRR or online as Pep-Pal on caregivers employed at the time of their pa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS (Meets all of the following criteria):
- Patients who have a primary diagnosis of solid tumor cancer at any stage that are within 12 weeks +/- of starting treatment, which includes either infusion chemo- or immunotherapy, oral targeted agents, or both.
- PATIENT CHARACTERISTICS:
- Patients who have a primary diagnosis of soled tumor cancer at any stage that are within 12 weeks of initiating treatment.
- Patient must be spouse or partner of the caregiver for at least a year and must live with caregiver
- Must be able to read/speak English
- 18 years of age or older
- CAREGIVER CHARACTERISTICS:
- A primary caregiver for the patient with a diagnosis of solid tumor cancer at any stage who are within 12 weeks of initiating treatment
- Spouse or partner of the patient for at least a year
- The caregiver must live with the patient
- Must be available to fully participate in an intervention (Virtual-PEPRR or PepPal) if assigned
- Must score 1 or greater on the PHQ-2 (depression) and/or GAD-2 (anxiety) during pre-screening.
- Must be employed at the time of the patient's diagnosis for a minimum of 20 hours/week with plans to remain employed and working during their patient's treatment. Caregivers that were furloughed or laid off due to Covid-19 who are actively looking for work will be included.
- Able to read and speak the English language
- Willingness to use a Smartphone
- Age 25 (inclusive) 65 (non-inclusive)
Exclusion
- Having a serious medical condition likely to influence neuroendocrine parameters
- Chronic use of steroid medications
- If Female, pregnant or planning to become pregnant in the next year
- History of a psychiatric illness unrelated to their experience as a caregiver with the past 18 months.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT04739696
Start Date
February 5 2021
End Date
September 30 2026
Last Update
January 13 2025
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045