CancerWBCCINCT02939755
Web-based Collaborative Care Intervention Study
A study testing Stepped collaborative care intervention in people with Cancer and Depression, run by University of Pittsburgh at 7 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 years
- 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
- 459 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Dec 2016to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- 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 at 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:
- lack of fluency in English; and
- evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
UPMC East
Monroeville, Pennsylvania, 15146
The University of Pittsburgh's Medical Center Passavant Hospital
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center Mercy
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh's Medical Center Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
UPMC Horizen
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
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 investigators will enroll patients at two UPMC sites: Montefiore Hospital, an academic medical center, and Passavant Hospital, a community based hospital. Based on our sample size estimate the investigators will have at least 364 patients and caregivers with complete data at 12 months follow up.
The patient and caregiver will be randomly assigned to one of two arms (intervention versus enhanced usual care) stratified by gender and vessel invasion. Because these factors are the two most robust prognostic factors in this patient population. At 6 and 12 months after enrollment, follow-up questionnaires and blood draws will be performed for patients and caregivers.
The stepped WBCC 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. 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.
Intervention fidelity (e.g., consistency across care coordinators) will be reduced by requiring the care coordinators to follow a 300 page manual and providing standardized training by the PI who is a clinical psychologist. Dr. Steel (PI) has received training and certification from the American Psycho-Oncology Society in the design and analysis of psycho-oncology clinical trials and intervention fidelity. The study investigators will not prescribe any medications but rather make recommendations to the patient's oncologist, PCP, psychiatrist, or pain management specialist who will be free to accept or reject the recommendations by the study team. Medication type, dosage, and adherence to medication (e.g., self-report and pharmacy refills) will be recorded for patients in the WBCC intervention and enhanced usual care arms.
- Conditions
- Cancer, Depression, Fatigue, Pain
- Being tested
- Stepped collaborative care intervention, Enhanced Usual Care
- Keywords
- Collaborative care intervention, Cancer, Depression, Palliative care, Quality of life, 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.
Quality of life (QoL)
Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Measured: change from baseline at 6 and 12 months
Secondary outcomes (17)
serum Interleukin (IL)-6,(mg/L)
Blood sample collection and process
Measured: change from baseline at 6 months and 12 months
serum Cancer Antigen 19-9 (u/ml)
Blood sample collection and process
Measured: change from baseline at 6 months and 12 months
serum carcinoembryonic antigen (u/ml)
Blood sample collection and process
Measured: change from baseline at 6 months and 12 months
serum Alpha feta protein (u/ml)
Blood sample collection and process
Measured: change from baseline at 6 months and 12 months
Caregivers' stress
Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale
Measured: change from baseline at 6 and 12 months
Caregivers' depression
Center for Epidemiological Studies- Depression
Measured: change from baseline at 6 and 12 months
dyadic adjustment
Dyadic Adjustment Scale
Measured: change from baseline at 6 and 12 months
Caregiver's blood pressure
Blood pressure readings
Measured: change from baseline at 6 and 12 months
Caregiver's Body Mass Index
Caregiver's height and weight calculations in inches and pounds using BMI calculator
Measured: change from baseline at 6 and 12 months
Caregiver's serum Interleukin-6
Blood sample collection and process
Measured: change from baseline at 6 and 12 months
Caregiver's metabolic syndrome
The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome
Measured: change from baseline at 6 and 12 months
Depression
Center for Epidemiological Studies- Depression
Measured: change from baseline at 6 and 12 months
Fatigue
Functional Assessment of Cancer Therapy -fatigue
Measured: change from baseline at 6 and 12 months
Pain level
Brief Pain Inventory
Measured: change from baseline at 6 and 12 months
serum Interleukin IL-1beta,(mg/L)
cytokine
Measured: change from baseline at 6 and 12 months
serum Tumor necrosis factor-alpha ((mg/L)
cytokine
Measured: change from baseline at 6 and 12 months
serum Inteferon-gamma ((mg/L)
cytokine
Measured: change from baseline at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 459 participants (actual)
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, PhD, Principal investigator, UPMC Departemnt of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939755
- Sponsor's protocol ID
- STUDY19050065
- Acronym
- WBCCI
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2016
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-Identified Data may be shared with investigators who request data from the Primary Investigator
Publications
Diamantis GN, Kim Y, Ofori-Atta Z, Devine L, Antoni MH, Reyes V, Johnson J, Kiefer G, Jiang Y, Zandberg DP, Nilsen M, Tohme S, Geller DA, Steel JL. The interdependence of depressive symptoms and sleep in dyads affected by cancer. Health Psychol. 2025 Apr;44(4):391-400. doi: 10.1037/hea0001449. Epub 2024 Nov 25.
PubMed 39585770Steel JL, George CJ, Terhorst L, Yabes JG, Reyes V, Zandberg DP, Nilsen M, Kiefer G, Johnson J, Marsh C, Bierenbaum J, Tageja N, Krauze M, VanderWeele R, Goel G, Ramineni G, Antoni M, Vodovotz Y, Walker J, Tohme S, Billiar T, Geller DA. Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial. Lancet. 2024 Apr 6;403(10434):1351-1361. doi: 10.1016/S0140-6736(24)00015-1. Epub 2024 Mar 12.
PubMed 38490230Steel JL, Amin A, Peyser T, Olejniczak D, Antoni M, Carney M, Tillman E, Hecht CL, Pandya N, Miceli J, Reyes V, Nilsen M, Johnson J, Kiefer G, Pappu B, Zandberg DP, Geller DA. The benefits and consequences of the COVID-19 pandemic for patients diagnosed with cancer and their family caregivers. Psychooncology. 2022 Jun;31(6):1003-1012. doi: 10.1002/pon.5891. Epub 2022 Feb 1.
PubMed 35083809Steel JL, Reyes V, Zandberg DP, Nilsen M, Terhorst L, Richards G, Pappu B, Kiefer G, Johnson J, Antoni M, Vodovotz Y, Spring M, Walker J, Geller DA. The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer. Contemp Clin Trials. 2021 Jun;105:106295. doi: 10.1016/j.cct.2021.106295. Epub 2021 Feb 5.
PubMed 33556589
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. 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
- ClinicalTrials.gov ID
- NCT02939755
- Acronym / sponsor ID
- WBCCI / STUDY19050065
- Conditions
- Cancer, Depression, Fatigue, Pain
- Keywords
- Collaborative care intervention, Cancer, Depression, Palliative care, Quality of life, Fatigue, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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 investigators will enroll patients at two UPMC sites: Montefiore Hospital, an academic medical center, and Passavant Hospital, a community based hospital. Based on our sample size estimate the investigators will have at least 364 patients and caregivers with complete data at 12 months follow up.
The patient and caregiver will be randomly assigned to one of two arms (intervention versus enhanced usual care) stratified by gender and vessel invasion. Because these factors are the two most robust prognostic factors in this patient population. At 6 and 12 months after enrollment, follow-up questionnaires and blood draws will be performed for patients and caregivers.
The stepped WBCC 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. 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.
Intervention fidelity (e.g., consistency across care coordinators) will be reduced by requiring the care coordinators to follow a 300 page manual and providing standardized training by the PI who is a clinical psychologist. Dr. Steel (PI) has received training and certification from the American Psycho-Oncology Society in the design and analysis of psycho-oncology clinical trials and intervention fidelity. The study investigators will not prescribe any medications but rather make recommendations to the patient's oncologist, PCP, psychiatrist, or pain management specialist who will be free to accept or reject the recommendations by the study team. Medication type, dosage, and adherence to medication (e.g., self-report and pharmacy refills) will be recorded for patients in the WBCC intervention and enhanced usual care arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- a spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the UPMC's Liver Cancer Center and
- age >21 years
Key exclusion criteria (7 listed)
- age < 21 years,
- lack of fluency in English,
- evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
- lack of fluency in English; and
- 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
Quality of life (QoL)
Time frame: change from baseline at 6 and 12 months
Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
17 secondary outcomes
serum Interleukin (IL)-6,(mg/L)
Time frame: change from baseline at 6 months and 12 months
serum Cancer Antigen 19-9 (u/ml)
Time frame: change from baseline at 6 months and 12 months
serum carcinoembryonic antigen (u/ml)
Time frame: change from baseline at 6 months and 12 months
serum Alpha feta protein (u/ml)
Time frame: change from baseline at 6 months and 12 months
Caregivers' stress
Time frame: change from baseline at 6 and 12 months
Caregivers' depression
Time frame: change from baseline at 6 and 12 months
dyadic adjustment
Time frame: change from baseline at 6 and 12 months
Caregiver's blood pressure
Time frame: change from baseline at 6 and 12 months
Caregiver's Body Mass Index
Time frame: change from baseline at 6 and 12 months
Caregiver's serum Interleukin-6
Time frame: change from baseline at 6 and 12 months
Caregiver's metabolic syndrome
Time frame: change from baseline at 6 and 12 months
Depression
Time frame: change from baseline at 6 and 12 months
Fatigue
Time frame: change from baseline at 6 and 12 months
Pain level
Time frame: change from baseline at 6 and 12 months
serum Interleukin IL-1beta,(mg/L)
Time frame: change from baseline at 6 and 12 months
serum Tumor necrosis factor-alpha ((mg/L)
Time frame: change from baseline at 6 and 12 months
serum Inteferon-gamma ((mg/L)
Time frame: change from baseline at 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 39585770Diamantis GN, Kim Y, Ofori-Atta Z, Devine L, Antoni MH, Reyes V, Johnson J, Kiefer G, Jiang Y, Zandberg DP, Nilsen M, Tohme S, Geller DA, Steel JL. The interdependence of depressive symptoms and sleep in dyads affected by cancer. Health Psychol. 2025 Apr;44(4):391-400. doi: 10.1037/hea0001449. Epub 2024 Nov 25.
- Derived from this study: PubMed 38490230Steel JL, George CJ, Terhorst L, Yabes JG, Reyes V, Zandberg DP, Nilsen M, Kiefer G, Johnson J, Marsh C, Bierenbaum J, Tageja N, Krauze M, VanderWeele R, Goel G, Ramineni G, Antoni M, Vodovotz Y, Walker J, Tohme S, Billiar T, Geller DA. Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial. Lancet. 2024 Apr 6;403(10434):1351-1361. doi: 10.1016/S0140-6736(24)00015-1. Epub 2024 Mar 12.
- Derived from this study: PubMed 35083809Steel JL, Amin A, Peyser T, Olejniczak D, Antoni M, Carney M, Tillman E, Hecht CL, Pandya N, Miceli J, Reyes V, Nilsen M, Johnson J, Kiefer G, Pappu B, Zandberg DP, Geller DA. The benefits and consequences of the COVID-19 pandemic for patients diagnosed with cancer and their family caregivers. Psychooncology. 2022 Jun;31(6):1003-1012. doi: 10.1002/pon.5891. Epub 2022 Feb 1.
- Derived from this study: PubMed 33556589Steel JL, Reyes V, Zandberg DP, Nilsen M, Terhorst L, Richards G, Pappu B, Kiefer G, Johnson J, Antoni M, Vodovotz Y, Spring M, Walker J, Geller DA. The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer. Contemp Clin Trials. 2021 Jun;105:106295. doi: 10.1016/j.cct.2021.106295. Epub 2021 Feb 5.
- 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. This study is not recruiting at the moment.
Jennifer L. Steel, PhD principal investigator
UPMC Departemnt of Surgery
7 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 7 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life (QoL) (time frame: change from baseline at 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939755, which also lists 4 linked publications.
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 16 Dec 2024.