Clinical trial · Interventional
Web-based Collaborative Care Intervention Study
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
NCT02939755CI-TRIAL-00083790WBCCIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
| Stepped collaborative care intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stepped collaborative care intervention
- description
- 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.
- interventionNames
- Behavioral: Stepped collaborative care intervention
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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.
References
Publications (4)
- DERIVEDDiamantis 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. PMID 39585770
- DERIVEDSteel 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. PMID 38490230
- DERIVEDSteel 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. PMID 35083809
- DERIVEDSteel 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. PMID 33556589