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Can a virtual stress program help working spouses care for cancer patients without burning out?

NCT ID NCT04739696

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing a virtual stress-management program for people who care for a spouse or partner with a solid tumor cancer while also holding a job. The program teaches skills such as paced respiration, relaxation, and coping with work and caregiving demands across eight sessions. The trial measures changes in caregiver depression and anxiety to see whether the program helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a virtual stress-management program combining psychoeducation, paced respiration, and relaxation
What this could lead to
If it works, this could give employed cancer caregivers a practical, remote way to manage depression and anxiety without leaving home.
What could go wrong
The program may not ease distress more than usual support, and self-reported mood scores can be influenced by many things outside the program. Results may not apply to caregivers who are not spouses or partners.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

538 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety disorder breast cancer breast neoplasm colon carcinoma colonic neoplasm Depression lung cancer lung neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Colon cancer Lung cancer Solid tumor, adult

Contacts and locations

Locations

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

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