Active Not RecruitingNot applicableNCT04739696

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

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.

Checked against the public recordLast updated Jan 13, 2025 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhaseNot applicable
U.S. locations1
SponsorUniversity of Colorado, Denver
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
University of Colorado, Denver
Interventions being studied
Behavioral: PEPRR; Behavioral: Pep-Pal
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 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 Criteria: * 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Colorado HospitalAurora, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 13, 2025. Always confirm current availability with the study team.

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