CARESCARESNCT07183527
Hybrid Type I Effectiveness-implementation Cluster Randomized Controlled Trial of CARES
A study testing CARES in people with CARES and Standard of Care, run by University of Pittsburgh at 1 site in United States.
Trial summary
The trial will examine the effectiveness and facilitators and barriers of implementation of CARES, an integrated screening and stepped collaborative care intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CARES, Standard of Care
- What is being tested?
- CARES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Cancer
- Age 18 years or older
- Read and write in English
Who cannot join
- Evidence of thought disorder
- Evidence of delusions
- Evidence of hallucinations
- Evidence of suicidal ideation with a plan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center (UPMC) Cancer Center
Pittsburgh, Pennsylvania, 15213
Jennifer L Steel, PhD, 412-692-2041, steejl@upmc.edu
About this study
Official title: Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial of CARES
The trial will examine the effectiveness and facilitators and barriers of implementation of CARES, an integrated screening and stepped collaborative care intervention
Read the detailed description
Over 18 million Americans are living with cancer. Half of them report clinically significant levels of depression, pain, and/or fatigue. According to the NIH consensus statement, these are the three most common and distressing cancer-related symptoms. These symptoms lead to poorer health-related quality of life (HRQoL) and cancer-related treatment adherence, higher unplanned health care utilization and costs, and reduced life expectancy.
Investigators observed in a trial of CARES, an integrated screening and stepped collaborative care intervention, that 75% versus 4% of participants initiated treatment when compared to standard of care. Improvements in HRQoL and reductions in pain, depression, fatigue, emergency room visits, readmissions to the hospital, and length of stay in the hospital were observed. The cost savings to the health care system was $17,085 per patient per year when compared to standard of care.
The overarching objective of the proposed study is to move CARES from research to routine clinical care. Investigators plans to test the effectiveness of CARES in a pragmatic trial or "real world" setting. An implementation-focused process evaluation of participant and clinician engagement with CARES guided by the RE-AIM framework will also be performed. Finally, to prepare to disseminate the intervention, a full cost-effectiveness analysis of CARES will be conducted.
- Conditions
- CARES, Standard of Care
- Being tested
- CARES, Standard of Care (SOC)
- Keywords
- implementation, stepped collaborative care, integrated screening and treatment, cluster randomized controlled trial, cancer, screening
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARESBehavioural
Integrated screening and stepped collaborative care
Standard of Care (SOC)Behavioural
Screening and referral of patient to provider in the community or cancer center
| Study group | Role | What they receive |
|---|---|---|
| CARES | Experimental | Integrated Screening and Stepped Collaborative Care Intervention Receives: Behavioral: CARES |
| Standard of Care (SOC) | Active comparator | Integrated screening and referred to treatment in the community and/or at the cancer center Receives: Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-General
Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 6 months
Functional Assessment of Cancer Therapy-General
Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life
Measured: Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits.
Secondary outcomes (33)
Patient Health Questionnaire-9
Depressive Symptoms. A higher score reflecting more severe depressive symptoms (range of scores 0-27)
Measured: Screening to baseline and baseline to 12 months. The primary outcome will be at 6-months.
Brief Pain Inventory.
Pain intensity and interference. The Pain, Enjoyment, and General Activity score (0-10) will be used as the secondary outcome. A higher score reflects greater pain interference.
Measured: Screening to baseline and baseline to 12 months. The primary outcome will be from baseline to 6-months
Generalized Anxiety Disorder -7
Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety.
Measured: Screening to baseline and baseline to 12 months. The primary time point is from baseline to 6 months.
FACIT Fatigue
Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue.
Measured: Baseline to 12 months. The primary time point will be 6 months.
PROMIS Depression
Depressive symptoms. The range is from a T scores of 0-100 with a higher score reflecting higher levels of depressive symptoms.
Measured: Baseline to 12 months. The primary time point is 6 months. The questionnaire will be used for treatment response 0-24 weeks (every 4 weeks).
PROMIS Anxiety
Anxiety. Scores range from a T score of 0-100 and a higher score reflects worse anxiety. Used for treatment response and primary endpoint 6 months.
Measured: Baseline to 12 months.
Fatigue Assessment Scale
Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue.
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 6 months. The questionnaire will also be used for treatment response 0-24 weeks (every 4 weeks).
Pain Visual Analog Scale
Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain.
Measured: Baseline to 12 months. The 6 month time point is primary. The questionnaire will also be used for treatment response 0-24 weeks (every 4 weeks) and then for the booster session at the end of treatment up until 12 months.
Pittsburgh Sleep Quality Index
Sleep problems. The total sleep quality (0-21) and subscales including the sleep duration (0-24), sleep disturbance (0-3), sleep latency (0-3), days of dysfunction (0-3), efficiency (0-3), overall sleep quality (0-3), medications to sleep (0-3). A higher score means more sleep problems.
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 6-months.
Interpersonal Support Evaluation List
Social support. A higher score reflects better social support. The range of scores 0-48 with subscales including appraisal (0-16), belonging (0-16), and tangible (0-16).
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 6-months.
Patient Health Questionnaire-9
Depressive Symptoms. Scores range from 0-27 with a higher score reflecting higher levels of depressive symptoms
Measured: Screening to baseline and baseline to 12 months. The 12 months outcome will be a measure of maintenance of benefits.
Brief Pain Inventory.
Pain intensity and interference. The Pain, Enjoyment, and General Activity score (0-10) will be used as the secondary outcome. A higher score reflects greater pain interference.
Measured: Screening to baseline and baseline to 12 months. The 12 month PEG score will reflect maintenance of treatment.
Generalized Anxiety Disorder -7
Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety.
Measured: Screening to baseline and baseline to 12 months. The 12 months time point will assess maintenance of change.
FACIT Fatigue
Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue.
Measured: Enrollment to the end of study for participant (12 months). The 12 months time point will reflect maintenance of change in fatigue.
COST
Financial toxicity. The range of scores is from 0-44 and a higher scores reflects a better financial well being.
Measured: Enrollment to the end of study for participant (12 months). The primary time point will be at 12 months.
Cost Coping
Cost coping strategies. The total score is the number of cost coping strategies a patient uses to manage their financial costs associated with their medical care. The total number of cost coping strategies is 0-26.
Measured: Enrollment to the end of study for participant (12 months). The primary time point will be 12 months.
EQ 5D 5L (this is the title of the instrument there is no non abbreviated title)
Health related quality of life. Total score ranges from 0-25 for part 1 and 0 to 100 for part 2. A higher score reflects a better quality of life.
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Cost Assessment
Health Care Utilization. There is no total score for this questionnaire as it will be used to estimate costs.
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
PROMIS Depression
Depressive symptoms. The range is from 0-100 with a higher score reflecting higher levels of depressive symptoms.
Measured: Enrollment to the end of study for participant (12 months). The 12 month time point will be used to assess maintenance of change.
PROMIS Anxiety
Anxiety. Scores range from 0-100 and a higher score reflects worse anxiety.
Measured: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenace of change.
Fatigue Assessment Scale
Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue.
Measured: Enrollment to the end of study for participant (12 months). The 12 months time point will assess maintenance of change.
Pain Visual Analog Scale
Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain.
Measured: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.
Pittsburgh Sleep Quality Index
Sleep problems. The total sleep quality (0-21) and subscales including the sleep duration (0-24), sleep disturbance (0-3), sleep latency (0-3), days of dysfunction (0-3), efficiency (0-3), overall sleep quality (0-3), medications to sleep (0-3). A higher score means more sleep problems.
Measured: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.
Interpersonal Support Evaluation List
Social support. A higher score reflects better social support. The range of scores 0-48 with subscales including appraisal (0-16), belonging (0-16), and tangible (0-16).
Measured: Enrollment to the end of study for participant (12 months). The 12-month time point will assess maintenance of change
Activity Based Costs
Health care costs. Range could be 0 to 10 million dollars
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Adherence to outpatient appointment
Adherence to outpatient appointments. Percent of appointments missed out of total appointment in 12 months.
Measured: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Complications
Number of complications from procedures or surgeries during 12 months post randomization. The primary time point is 12 months.
Measured: Baseline to 12 months
Length of Stay in the Hospital
Number of days patient was in the hospital. The primary end point is 12 months
Measured: Baseline to 12 months
Emergency Room Visits
Number of emergency room visits in 12 months post-randomization. The primary end point is 12 months
Measured: 12 months
30-day readmissions
Unplanned readmission to the hospital after a procedure or surgery within 30 days. Primary end point 12 months
Measured: Baseline to 12 months
90-day readmission
Unplanned readmission to the hospital after a procedure or surgery within 90 days. The primary endpoint is 12 months
Measured: Baseline to 12 months
PROMIS Fatigue
Assesses fatigue in cancer patients. Higher score reflects greater fatigue. Score range from a T score 0-100. Primary end point baseline to 6 months
Measured: Screening to baseline and baseline to 12 months
PROMIS Fatigue
Assesses fatigue in cancer patients. Higher score reflects greater fatigue. Score range from a T score 0-100. Secondary endpoint 12 months
Measured: Screening to baseline and baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start8 Aug 2025
- Primary completion10 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CARESStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer Steel, University of Pittsburgh
- Investigators
- Jennifer L Steel, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183527
- Sponsor's protocol ID
- STUDY24070065
- Other IDs
- 1R01CA296402
- Acronym
- CARES
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be placed in data repository
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial of CARES
- ClinicalTrials.gov ID
- NCT07183527
- Acronym / sponsor ID
- CARES / STUDY24070065
- Conditions
- CARES, Standard of Care
- Keywords
- implementation, stepped collaborative care, integrated screening and treatment, cluster randomized controlled trial, cancer, screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 10 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will examine the effectiveness and facilitators and barriers of implementation of CARES, an integrated screening and stepped collaborative care intervention
Detailed description
Over 18 million Americans are living with cancer. Half of them report clinically significant levels of depression, pain, and/or fatigue. According to the NIH consensus statement, these are the three most common and distressing cancer-related symptoms. These symptoms lead to poorer health-related quality of life (HRQoL) and cancer-related treatment adherence, higher unplanned health care utilization and costs, and reduced life expectancy.
Investigators observed in a trial of CARES, an integrated screening and stepped collaborative care intervention, that 75% versus 4% of participants initiated treatment when compared to standard of care. Improvements in HRQoL and reductions in pain, depression, fatigue, emergency room visits, readmissions to the hospital, and length of stay in the hospital were observed. The cost savings to the health care system was $17,085 per patient per year when compared to standard of care.
The overarching objective of the proposed study is to move CARES from research to routine clinical care. Investigators plans to test the effectiveness of CARES in a pragmatic trial or "real world" setting. An implementation-focused process evaluation of participant and clinician engagement with CARES guided by the RE-AIM framework will also be performed. Finally, to prepare to disseminate the intervention, a full cost-effectiveness analysis of CARES will be conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| CARES | Experimental | Behavioral: CARESIntegrated Screening and Stepped Collaborative Care Intervention |
| Standard of Care (SOC) | Active comparator | Behavioral: Standard of Care (SOC)Integrated screening and referred to treatment in the community and/or at the cancer center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Cancer
- Age 18 years or older
- Read and write in English
Key exclusion criteria (4 listed)
- Evidence of thought disorder
- Evidence of delusions
- Evidence of hallucinations
- Evidence of suicidal ideation with a plan
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 |
|---|---|---|
| CARESIntegrated screening and stepped collaborative care | Behavioural | CARES |
| Standard of Care (SOC)Screening and referral of patient to provider in the community or cancer center | Behavioural | Standard of Care (SOC) |
Primary outcome
Functional Assessment of Cancer Therapy-General
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6 months
Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life
Functional Assessment of Cancer Therapy-General
Time frame: Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits.
Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life
33 secondary outcomes
Patient Health Questionnaire-9
Time frame: Screening to baseline and baseline to 12 months. The primary outcome will be at 6-months.
Brief Pain Inventory.
Time frame: Screening to baseline and baseline to 12 months. The primary outcome will be from baseline to 6-months
Generalized Anxiety Disorder -7
Time frame: Screening to baseline and baseline to 12 months. The primary time point is from baseline to 6 months.
FACIT Fatigue
Time frame: Baseline to 12 months. The primary time point will be 6 months.
PROMIS Depression
Time frame: Baseline to 12 months. The primary time point is 6 months. The questionnaire will be used for treatment response 0-24 weeks (every 4 weeks).
PROMIS Anxiety
Time frame: Baseline to 12 months.
Fatigue Assessment Scale
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6 months. The questionnaire will also be used for treatment response 0-24 weeks (every 4 weeks).
Pain Visual Analog Scale
Time frame: Baseline to 12 months. The 6 month time point is primary. The questionnaire will also be used for treatment response 0-24 weeks (every 4 weeks) and then for the booster session at the end of treatment up until 12 months.
Pittsburgh Sleep Quality Index
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6-months.
Interpersonal Support Evaluation List
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6-months.
Patient Health Questionnaire-9
Time frame: Screening to baseline and baseline to 12 months. The 12 months outcome will be a measure of maintenance of benefits.
Brief Pain Inventory.
Time frame: Screening to baseline and baseline to 12 months. The 12 month PEG score will reflect maintenance of treatment.
Generalized Anxiety Disorder -7
Time frame: Screening to baseline and baseline to 12 months. The 12 months time point will assess maintenance of change.
FACIT Fatigue
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point will reflect maintenance of change in fatigue.
COST
Time frame: Enrollment to the end of study for participant (12 months). The primary time point will be at 12 months.
Cost Coping
Time frame: Enrollment to the end of study for participant (12 months). The primary time point will be 12 months.
EQ 5D 5L (this is the title of the instrument there is no non abbreviated title)
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Cost Assessment
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
PROMIS Depression
Time frame: Enrollment to the end of study for participant (12 months). The 12 month time point will be used to assess maintenance of change.
PROMIS Anxiety
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenace of change.
Fatigue Assessment Scale
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point will assess maintenance of change.
Pain Visual Analog Scale
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.
Pittsburgh Sleep Quality Index
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.
Interpersonal Support Evaluation List
Time frame: Enrollment to the end of study for participant (12 months). The 12-month time point will assess maintenance of change
Activity Based Costs
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Adherence to outpatient appointment
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Complications
Time frame: Baseline to 12 months
Length of Stay in the Hospital
Time frame: Baseline to 12 months
Emergency Room Visits
Time frame: 12 months
30-day readmissions
Time frame: Baseline to 12 months
90-day readmission
Time frame: Baseline to 12 months
PROMIS Fatigue
Time frame: Screening to baseline and baseline to 12 months
PROMIS Fatigue
Time frame: Screening to baseline and baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be placed in data repository
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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.
Jennifer L Steel, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARES in people with CARES and Standard of Care, run by University of Pittsburgh 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 3 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: looking for participants now, as of the sponsor's last update on 10 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Steel, PhD (14126922041, Steejl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-General (time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6 months). The study lists 2 primary outcomes in all. 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 10 Aug 2026.