Clinical trial · Interventional
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
NCT04739696CI-TRIAL-00084580eCareactive not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pep-Pal | Behavioral | — | UNRESOLVED |
| PEPRR | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Caregiver Control
- description
- biomarker analysis; questionnaire administration; survey administration; treatment as usual
- type
- EXPERIMENTAL
- label
- Caregiver Intervention
- description
- biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention.
- interventionNames
- Behavioral: PEPRR
- type
- EXPERIMENTAL
- label
- Caregiver Self-Directed
- description
- biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.