CancerCARES-LiteNCT05601206
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
A study testing Stepped collaborative care intervention in people with Cancer and Depression, run by University of Pittsburgh at 2 sites in United States.
Trial summary
To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Depression, Fatigue
- What is being tested?
- Stepped collaborative care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jan 2028to 1 Jun 2032
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year; age >21 years; no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported.
- Caregivers:
- A spouse or cohabitating intimate partner of an advanced cancer patient being evaluated the UPMC's Liver Cancer Center and age >21 years
Who cannot join
- Patients:
- Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
- Caregivers:
- Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Pittsburgh Medical Center Montefiore Liver Cancer Center
Pittsburgh, Pennsylvania, 15213
Jennifer L Steel, PhD, 412-692-2041, steeljl@upmc.edu
University of Pittsburgh's Medical Center Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
Jennifer L. Steel, PhD, 412-624-3959, steeljl@upmc.edu
About this study
To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.
Read the detailed description
The intervention is designed to maintain quality of life for those in greatest need and least access to resources. This innovative and scalable web-based collaborative care intervention is expected not only to improve patients' quality of life, at the end of life, but also reduce caregiver stress and depression, and potentially health morbidity and mortality of patients and spousal and intimate partner caregivers from socioeconomically disadvantaged backgrounds. Study findings are expected to lead to research examining the dissemination and implementation of the intervention.
- Conditions
- Cancer, Depression, Fatigue, Pain, Sleep
- Being tested
- Stepped collaborative care intervention, Enhanced Usual Care
- Keywords
- Cancer Depression Fatigue Pain
- Medical subject headings
- Neoplasms, Depression, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped collaborative care interventionBehavioural
Also called Treatment
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Enhanced Usual CareBehavioural
Also called Control
Usual care from health providers
| Study group | Role | What they receive |
|---|---|---|
| Stepped collaborative care intervention | Experimental | The 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds. Receives: Behavioral: Stepped collaborative care intervention |
| Enhanced Usual Care | Active comparator | Patients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change from baseline at 6 months
Pain Level
Brief Pain Inventory (BPI)
Measured: Change from baseline at 6 months
Functioning
Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)
Measured: Change from baseline at 6 months
Depression
Center for Epidemiological Studies -Depression (CESD)
Measured: Change from baseline at 6 months
Stress
Perceived Stress Scale (PSS)
Measured: Change from baseline at 6 months
Fatigue
Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)
Measured: Change from baseline at 6 months
Caregiver Quality of Life
Caregiver Quality of Life Questionnaire (CQOL)
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start14 Jan 2028 (estimated)
- Primary completion15 Dec 2030 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Steel, University of Pittsburgh
- Investigators
- Jennifer L Steel, Principal investigator, UPMC Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601206
- Sponsor's protocol ID
- STUDY22050018
- Acronym
- CARES-Lite
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-Identified Data may be shared with investigators who request data from the Primary Investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
- ClinicalTrials.gov ID
- NCT05601206
- Acronym / sponsor ID
- CARES-Lite / STUDY22050018
- Conditions
- Cancer, Depression, Fatigue, Pain, Sleep
- Keywords
- Cancer Depression Fatigue Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 Jan 2028 (estimated)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 1 Nov 2022 (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.
To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.
Detailed description
The intervention is designed to maintain quality of life for those in greatest need and least access to resources. This innovative and scalable web-based collaborative care intervention is expected not only to improve patients' quality of life, at the end of life, but also reduce caregiver stress and depression, and potentially health morbidity and mortality of patients and spousal and intimate partner caregivers from socioeconomically disadvantaged backgrounds. Study findings are expected to lead to research examining the dissemination and implementation of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Stepped collaborative care intervention | Experimental | Behavioral: Stepped collaborative care interventionThe 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CarePatients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients:
- Biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year; age >21 years; no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported.
- Caregivers:
- A spouse or cohabitating intimate partner of an advanced cancer patient being evaluated the UPMC's Liver Cancer Center and age >21 years
Key exclusion criteria (4 listed)
- Patients:
- Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
- Caregivers:
- Age < 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
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 |
|---|---|---|
| Stepped collaborative care interventionAlso: TreatmentUsing website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional | Behavioural | Stepped collaborative care intervention |
| Enhanced Usual CareAlso: ControlUsual care from health providers | Behavioural | Enhanced Usual Care |
Primary outcome
Sleep Quality
Time frame: Change from baseline at 6 months
Pittsburgh Sleep Quality Index (PSQI)
Pain Level
Time frame: Change from baseline at 6 months
Brief Pain Inventory (BPI)
Functioning
Time frame: Change from baseline at 6 months
Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)
Depression
Time frame: Change from baseline at 6 months
Center for Epidemiological Studies -Depression (CESD)
Stress
Time frame: Change from baseline at 6 months
Perceived Stress Scale (PSS)
Fatigue
Time frame: Change from baseline at 6 months
Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)
Caregiver Quality of Life
Time frame: Change from baseline at 6 months
Caregiver Quality of Life Questionnaire (CQOL)
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. De-Identified Data may be shared with investigators who request data from the Primary Investigator
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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 principal investigator
UPMC Department of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped collaborative care intervention in people with Cancer and Depression, run by University of Pittsburgh at 2 sites 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 4 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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, steeljl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Change from baseline at 6 months). The study lists 7 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 9 Apr 2026.