NCT04739696Active, not recruiting
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
Cancer Caregivers and Their Struggle(s) Between Work and Family
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 538 (actual)
- First submitted
- 22 Jan 2021
- Start date
- 5 Feb 2021
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT04739696
What you commit to
- Study type: Interventional
- Participants enrolled: 538
- From 5 Feb 2021 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of steroid medications
Other illness
- Having a serious medical condition likely to influence neuroendocrine parameters
- History of a psychiatric illness unrelated to their experience as a caregiver with the past 18 months.
Other
- If Female, pregnant or planning to become pregnant in the next year
Who the study is looking for
- 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)
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.