Stepped Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
(CARES-Lite Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new web-based program can reduce depression, pain, and fatigue in people with advanced cancer, while also supporting their caregivers by reducing stress and heart-related risks. The trial includes two groups: one receives regular care with additional support from a care coordinator (enhanced usual care), and the other accesses a special online program with regular check-ins (stepped collaborative care intervention). The trial seeks participants with specific types of advanced cancer affecting the liver or breast, along with their supportive partners. Participants must communicate in English and not have severe mental health issues such as hallucinations or suicidal thoughts. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for advanced cancer patients and their caregivers.
What prior data suggests that this stepped collaborative care intervention is safe for cancer patients and their family caregivers?
Research has shown that the stepped collaborative care approach is generally safe for cancer patients. Studies have found that this method can reduce symptoms like depression, pain, and fatigue without major safety issues. Participants in earlier studies reported improvements in these areas, indicating that the treatment is well-tolerated. No significant harmful side effects have been reported. The approach includes regular contact with a care coordinator and access to online resources, which helps manage symptoms effectively. Overall, evidence suggests that this treatment is safe and can improve the quality of life for those with advanced cancer.12345
Why are researchers excited about this trial?
Researchers are excited about the Stepped Collaborative Care Intervention because it offers a comprehensive support system for cancer patients and their caregivers, especially those from socioeconomically disadvantaged backgrounds. Unlike standard care, which typically involves routine medical visits and referrals, this intervention provides personalized, biweekly contact with a care coordinator, both by phone and in person, ensuring ongoing support. Additionally, patients have 24/7 access to a specially designed website, offering resources tailored to their needs. This continuous and holistic approach aims to address not just physical symptoms but also emotional and logistical challenges, potentially improving overall quality of life.
What evidence suggests that this trial's treatments could be effective for reducing symptoms in cancer patients and their caregivers?
Research has shown that a stepped collaborative care approach, which participants in this trial may receive, can help reduce symptoms such as depression, pain, and fatigue in cancer patients. In past studies, this method, often involving counseling and medication, led to noticeable improvements in these symptoms. Specifically, about 75% of patients who began treatment with a counselor managed their symptoms more effectively. This care model also enhances the overall quality of life related to health, making it a promising option for those dealing with advanced cancer.12678
Who Is on the Research Team?
Jennifer L Steel
Principal Investigator
UPMC Department of Surgery
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a web-based stepped collaborative care intervention with biweekly contact from a care coordinator and face-to-face visits approximately every 2 months
Follow-up
Participants are monitored for changes in sleep quality, pain level, stress, functioning, depression, fatigue, and caregiver quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced Usual Care
- Stepped collaborative care intervention
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Enhanced Usual Care is already approved in United States, European Union, China for the following indications:
- Hepatic encephalopathy
- Constipation
- Hepatic encephalopathy
- Constipation
- Hepatic encephalopathy
- Constipation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Citations
Stepped-care models for cancer symptom management - PMC
This review synthesized evidence on the efficacy and cost-effectiveness of stepped-care interventions delivered to manage therapy-related symptoms in cancer ...
2.
cancer.gov
cancer.gov/news-events/cancer-currents-blog/2024/cancer-symptoms-stepped-collaborative-careApproach Integrates Cancer Symptom Management into ...
Stepped collaborative care, involving cognitive behavioral therapy and/or medication, improved symptoms of depression, pain, and fatigue in ...
The promise of scalable symptom surveillance with ...
Guidelines for managing deleterious symptoms from cancer and its treatments have been largely underused in practice.
Efficacy of a stepped collaborative care intervention for ...
Conclusions: The stepped collaborative care intervention not only reduced depressive symptoms, but patients randomized to this intervention had lower ...
Protecting Patient-Centered Oncology Care from Harmful ...
NCODA strongly opposes step therapy policies in oncology, as they delay appropriate treatment, increase the risk of avoidable complications and ...
Novel, Stepped Collaborative Care Improves Symptom ...
During the study period, about 75% of the patients in the intervention group who were offered support began treatment with a trained counselor, ...
Integrated Screening and Stepped Collaborative Care ...
Patients in the stepped collaborative care group had greater reductions in depressive symptoms, pain, and fatigue, with the benefits being ...
The impact of patient engagement on patient safety in care ...
This review will allow evidence-based conclusions about types and effects of different PFE interventions for transitional safety in oncology care.
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