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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA231387-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Specific Aims
OUTLINE: Caregivers are randomized to one of 3 groups (1:1:1) 1) Treatment as usual (TAU), 2) Virtual-PEPRR, or 3) Pep-Pal.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiver Control | No Intervention | biomarker analysis; questionnaire administration; survey administration; treatment as usual | |
| Caregiver Intervention | Experimental | biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention. |
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| Caregiver Self-Directed | Experimental | biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEPRR | Behavioral | Briefly presented in the following order, sessions will include: 1) Overview and Introduction to Stress Management 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with work and caregiver stress, 5) Strategies for maintaining energy and stamina with caregiver and work demands, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs to employers and your loved ones, and 8) Getting the support they need including work accommodations and/or legal protections (e.g., Family Medical Leave Act, Americans with Disabilities Act) |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD) | Change in caregiver depressive symptoms. Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology. | Baseline, 3 months, 6 months, 9 months, 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver: Change in Spielberger State-Trait Anxiety Inventory (STAI) | Change in caregiver anxiety. The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety). |
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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:
CAREGIVER CHARACTERISTICS:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy J Bradley, PhD | University of Colorado Denver (Anschutz Medical Campus) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 13, 2025 | |
| Reset | Nov 26, 2025 | |
| Release | Dec 2, 2025 | |
| Reset | Dec 17, 2025 | |
| Release | Jan 20, 2026 | |
| Reset | Feb 5, 2026 | |
| Release | Feb 17, 2026 | |
| Reset | Mar 9, 2026 | |
| Release | Apr 3, 2026 | |
| Reset | Apr 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 13, 2025 | Nov 26, 2025 | |||
| Dec 2, 2025 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Pep-Pal | Behavioral | Pep-Pal program consisted of 11 sessions: 1) Introduction to stress management, 2) Stress and the mind body connection, 3) How thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty, 7) Managing changing relationships and communicating needs, 8) Getting the support they need; 9) Employment related challenges and resources for working caregivers; 10) Employment session one; 11) Employment session two |
|
| Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Caregiver: Change in Perceived Stress Scale (PSS) | Change in caregiver perceived stress. The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress. | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Caregiver: Health Care Utilization | Caregiver electronic health records and supplemented by Colorado All Payer Claims Data and self-report | Baseline, 12 month follow up |
| Caregiver: Change in Adrenal Activity Over Time | Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis. | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Caregiver: Change in Caregiver Telomere Length Over Time | Telomere length was assessed as a measure of cellular aging in blood samples from participants. | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Patient: Change in Center for Epidemiological Studies Depression Scale (CESD) | Change in patient depressive symptoms. Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology. | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Patient: Change in Spielberger State-Trait Anxiety Inventory (STAI) | Change in patient anxiety. The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety). | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Patient: Change in Perceived Stress Scale | Change in patient perceived stress. The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress. | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Patient: Health Care Utilization | Patient electronic health records and supplemented by Colorado All Payer Claims Data | Baseline, 12 month follow up |
| Patient: Change in MD Anderson Symptom Inventory (MDASI) | Patient symptom management. the MD Anderson Symptom Inventory (MDASI) core scale, which assesses 13 symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, memory problems, lack of appetite, drowsiness, dry mouth, numbness, sadness, and vomiting) on a 0-10 scale. | Baseline, 3 month, 6 month, 9 month, 12 month follow up |
| Caregiver: Employment status | Caregiver self-report employment and weekly hours worked questions from Current Population Survey (CPS) | Baseline, 12 month follow up |
| Caregiver: Job Satisfaction | Caregiver self-report job satisfaction. Job satisfaction is measured by a single-item assessment tool assessing whether or not the participant was satisfied with their current job. Satisfaction was measured on a 0-7 scale. Higher score indicates a higher level of satisfaction. | Baseline, 12 month follow up |
| Dec 17, 2025 |
| Jan 20, 2026 | Feb 5, 2026 |
| Feb 17, 2026 | Mar 9, 2026 |
| Apr 3, 2026 | Apr 23, 2026 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |