Active Not RecruitingNot applicableNCT04739696
Official study title

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

Study 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 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPEPRR and Pep-Pal

The study team can explain what participation involves.

Who it may be forBreast Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 11, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Colorado, Denver

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Reasons someone may not be able to joinExclusion 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: Sep 11, 2026. Always confirm current availability with the study team.

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