Breast Cancer Clinical Trial

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

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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Full Description

Specific Aims

Evaluate the impact of PsychoEducation Paced Respiration and Relaxation (PEPRR) delivered remotely as Virtual-PEPRR or online as Pep-Pal on caregivers employed at the time of their patient's cancer diagnosis and preselected based on high self-reported distress.
Evaluate patient psychological status and healthcare utilization in patients whose caregivers received Virtual-PEPRR or Pep-Pal versus TAU
Evaluate whether caregivers employment outcomes are associated with patient symptom management as an exploratory question.

OUTLINE: Caregivers are randomized to one of 3 groups (1:1:1) 1) Treatment as usual (TAU), 2) Virtual-PEPRR, or 3) Pep-Pal.

Group I (treatment as usual [TAU]): Caregivers randomized to TAU will not participate in the stress management interventions. The TAU condition for this study takes into account published recommendations for an adequate representation of TAU. All participants regardless of randomization will be encouraged to use available psychological resources.
Group II (Virtual PsychoEducation Paced Respiration and Relaxation [Virtual-PEPRR]): Caregivers participating in the Virtual-PEPRR intervention will consist of eight 60-75 minute video or telephone sessions. Each Virtual-PEPRR session will be devoted to a specific topic with the goal of assisting the caregiver in developing and applying stress-management skills both in caregiving as well as in their work setting. Sessions include problem-solving, identifying cognitive distortions, application of relaxation techniques such as the emWave2, acquiring new coping skills, utilizing social support, and establishing appropriate goals, and finding support. All caregivers in Virtual-PEPRR will be provided a Caregiver Workbook that includes information about the session topics and homework assignments.
Group III (Pep-Pal): Pep-Pal is a mobilized version of Virtual-PEPRR. Pep-Pal includes eleven web-based video modules replicate essential components of each session of Virtual-PEPRR, but in shorter format (<20 minute. duration) with engaging relaxation exercises. The modules include learning skills in problem-solving, identifying cognitive distortions, using techniques, acquiring new coping skills, utilizing social support, establishing suitable goals, and finding support. Pep-Pal includes "Mini-Peps" which are video guided, 3-minute stress reduction exercises that the caregiver can access any time. Caregivers randomized to will complete at times convenient web-accessible by smartphone, tablet, laptop, or desktop computer. more than one module a week, repeat session, Mini-Peps as frequently desired.

Caregivers and patients undergo psychosocial assessments prior to randomization, and at 3 months, 6 months, 9 months and 1 year after baseline. At each phase, caregivers and patients will complete battery of questionnaires that includes the Center for Epidemiological Studies-Depression scale (CES-D), the perceived stress scale (PSS), and the State-Trait Anxiety Inventory (STAI). Caregivers will be asked monthly to complete eight very short questions Patient-Reported Outcomes Measurement Information System (PROMIS). Additionally the patient will complete the MD Anderson Symptom Inventory each time while the caregiver completes questionnaires will cover details about how being a caregiver has affected their lives, details about employment, insurance and accommodations, general physical and mental well-being, and the impact Covid-19 has had on their lives. The patient and the caregiver will additionally complete a demographic questionnaire that includes questions regarding age, diagnosis, income, and other standard questions regarding nutrition, health behaviors, and health services utilization. At study completion, an exit questionnaire will address each subject's evaluation of the study and the group in which they were assigned.

Saliva and hair samples from caregivers will be collected every three months: baseline, 3 months, 6 months, 9 months and 1 year after baseline.

View Eligibility Criteria

Eligibility Criteria

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:

A spouse or partner of the caregiver for at least a year
Live with caregiver
Able to read and speak the English language

CAREGIVER CHARACTERISTICS:

A primary caregiver for the patient with a diagnosis of solid tumor cancer
Spouse or partner of the patient for at least a year
Caregiver must live with 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

Exclusion Criteria:

History of a psychiatric illness unrelated to their experience as a caregiver within the past 18 months
No serious medical condition likely to influence neuroendocrine parameters
No chronic steroid medication use (caregiver)

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT04739696

Recruitment Status:

Recruiting

Sponsor:

University of Colorado, Denver

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There are 2 Locations for this study

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University of Colorado Hospital
Aurora Colorado, 80045, United States
Kaiser Permanente Colorado
Denver Colorado, 80247, United States More Info
Debra Ritzwoller, PhD
Contact
303-636-2400

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT04739696

Recruitment Status:

Recruiting

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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