Web-based Collaborative Care Intervention Study

NCT02939755 | Completed DMC

• 1 other identifier: STUDY19050065
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Cancer; Depression; Fatigue; Pain

Keywords

Collaborative care intervention; Cancer; Depression; Palliative care; Quality of life; Fatigue; Pain

Outcome Measures

Primary Outcomes (1)

• Quality of life (QoL)

  Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire

  change from baseline at 6 and 12 months

Secondary Outcomes (17)

• serum Interleukin (IL)-6,(mg/L)

  change from baseline at 6 months and 12 months

• serum Cancer Antigen 19-9 (u/ml)

  change from baseline at 6 months and 12 months

• serum carcinoembryonic antigen (u/ml)

  change from baseline at 6 months and 12 months

• serum Alpha feta protein (u/ml)

  change from baseline at 6 months and 12 months

• Caregivers' stress

  change from baseline at 6 and 12 months

Other Outcomes (2)

• Health care utilization

  1 year

• Health care costs

  12 months

Study Arms (2)

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.

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.

Behavioral: Enhanced Usual Care

Interventions

Stepped collaborative care intervention BEHAVIORAL

Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional

Also known as: treatment

Stepped collaborative care intervention

Enhanced Usual Care BEHAVIORAL

usual care from health providers

Also known as: control

Enhanced Usual Care

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (7)

UPMC East

Monroeville, Pennsylvania, 15146, United States

Location

The University of Pittsburgh's Medical Center Passavant Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center Mercy

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh's Medical Center Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Horizen

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (4)

• 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.

  PMID: 39585770 DERIVED

• Steel 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 DERIVED

• Steel 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 DERIVED

• Steel 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Depression; Fatigue; Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Jennifer L. Steel, PhD

  UPMC Departemnt of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Associate Professor

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 20, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the end of the study for up to one year.
• Access Criteria: Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion

Locations

US (7)