Clinical trial NCT04739696: Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
Official title: Cancer Caregivers and Their Struggle(s) Between Work and Family
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Colon Cancer
Solid Tumor, Adult
Keywords: depression
stress
caregiving
anxiety
psychoeducation intervention
psycho-oncology
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-05
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 relaxation 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 Pep-Pal will complete modules at times that are convenient and web-accessible by smartphone, tablet, laptop, or desktop computer. Caregivers can complete more than one module a week, repeat any session, and access the Mini-Peps as frequently as 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.

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:

* 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.

Primary outcomes:
measure: Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months follow up
Secondary outcomes:
measure: Caregiver: Change in Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Caregiver: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Caregiver: Health Care Utilization
timeFrame: Baseline, 12 month follow up
measure: Caregiver: Change in Adrenal Activity Over Time
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Caregiver: Change in Caregiver Telomere Length Over Time
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Patient: Change in Center for Epidemiological Studies Depression Scale (CESD)
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Patient: Change in Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Patient: Change in Perceived Stress Scale
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Patient: Health Care Utilization
timeFrame: Baseline, 12 month follow up
measure: Patient: Change in MD Anderson Symptom Inventory (MDASI)
timeFrame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
measure: Caregiver: Employment status
timeFrame: Baseline, 12 month follow up
measure: Caregiver: Job Satisfaction
timeFrame: Baseline, 12 month follow up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado Denver (Anschutz Medical Campus)
name: Cathy J Bradley, PhD
role: PRINCIPAL_INVESTIGATOR
References: