Breast CancereCareNCT04739696
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
A study testing PEPRR and Pep-Pal in people with Breast Cancer and Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colon Cancer
- What is being tested?
- PEPRR and Pep-Pal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 17Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Cancer Caregivers and Their Struggle(s) Between Work and Family
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.
Read the 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.
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer, Solid Tumor, Adult
- Being tested
- PEPRR, Pep-Pal
- Keywords
- depression, stress, caregiving, anxiety, psychoeducation intervention, psycho-oncology
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPRRBehavioural
Also called Virtual-PEPRR, PsychoEducation Paced Respiration and Relaxation
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)
Pep-PalBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PEPRR |
| Caregiver Self-Directed | Experimental | biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention. Receives: Behavioral: Pep-Pal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months follow up
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline, 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start5 Feb 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cathy J Bradley, PhD, Principal investigator, University of Colorado Denver (Anschutz Medical Campus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739696
- Sponsor's protocol ID
- 20-2458.cc
- Other IDs
- 5R01CA231387-02
- Acronym
- eCare
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2021
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Caregivers and Their Struggle(s) Between Work and Family
- ClinicalTrials.gov ID
- NCT04739696
- Acronym / sponsor ID
- eCare / 20-2458.cc
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer, Solid Tumor, Adult
- Keywords
- depression, stress, caregiving, anxiety, psychoeducation intervention, psycho-oncology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 538 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caregiver Control | No intervention | –biomarker analysis; questionnaire administration; survey administration; treatment as usual |
| Caregiver Intervention | Experimental | Behavioral: PEPRRbiomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention. |
| Caregiver Self-Directed | Experimental | Behavioral: Pep-Palbiomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEPRRAlso: Virtual-PEPRR, PsychoEducation Paced Respiration and RelaxationBriefly 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) | Behavioural | Caregiver Intervention |
| Pep-PalPep-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 | Behavioural | Caregiver Self-Directed |
Primary outcome
Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months follow up
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.
12 secondary outcomes
Caregiver: Change in Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Caregiver: Change in Perceived Stress Scale (PSS)
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Caregiver: Health Care Utilization
Time frame: Baseline, 12 month follow up
Caregiver: Change in Adrenal Activity Over Time
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Caregiver: Change in Caregiver Telomere Length Over Time
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Patient: Change in Center for Epidemiological Studies Depression Scale (CESD)
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Patient: Change in Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Patient: Change in Perceived Stress Scale
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Patient: Health Care Utilization
Time frame: Baseline, 12 month follow up
Patient: Change in MD Anderson Symptom Inventory (MDASI)
Time frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up
Caregiver: Employment Status
Time frame: Baseline, 12 month follow up
Caregiver: Job Satisfaction
Time frame: Baseline, 12 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy J Bradley, PhD principal investigator
University of Colorado Denver (Anschutz Medical Campus)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEPRR and Pep-Pal in people with Breast Cancer and Lung Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD) (time frame: Baseline, 3 months, 6 months, 9 months, 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.