A study called CARES in the USA examined the impact of a new intervention in cancer care on patients, family caregivers, and economic outcomes. The intervention involved integrated screening and stepped collaborative care.
The study titled "Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES)" was published on March 12, 2024. The aim of this randomized, parallel, phase 3 trial was to evaluate the effectiveness of an integrated screening and novel stepped collaborative care intervention compared to the standard of care for patients with cancer experiencing symptoms like depression, pain, or fatigue.
The research was conducted in 29 oncology outpatient clinics affiliated with the UPMC Hillman Cancer Center in the USA. The participants included patients aged 21 years and older with any type of cancer and clinical levels of depression, pain, or fatigue. Family caregivers aged 21 years and older providing care to a cancer patient who consented to participate were also eligible. The patients were randomly assigned to receive stepped collaborative care or standard of care using a central, permuted block design. The treatment allocation was concealed, and the biostatistician, oncologists, and outcome assessors were blinded to the assignment.
The stepped collaborative care intervention involved weekly cognitive behavioral therapy sessions lasting 50–60 minutes delivered by a care coordinator through telemedicine platforms like telephone or videoconferencing. Additionally, pharmacotherapy for symptoms could be recommended by the treatment team or initiated based on the patient's preference. The standard of care, on the other hand, included screening patients for symptoms and referring them to healthcare providers for treatment.
The primary outcome of the study was the health-related quality of life in patients at 6 months, with the maintenance of treatment benefits assessed at 12 months. The analysis was conducted based on the intention to treat principle, which included patients with missing follow-up assessments. The study registered with ClinicalTrials.gov under the identifier NCT02939755.
Between December 2016 and April 2021, a total of 459 patients and 190 family caregivers were enrolled in the trial. Of these, 237 patients were assigned to stepped collaborative care and 222 to standard of care. The majority of patients were female (56%). Patients receiving stepped collaborative care showed a significant improvement in health-related quality of life at 0–6 months compared to those receiving standard care (p=0.013, effect size 0.09). The improvements in emotional, functional, and physical wellbeing were also greater in the stepped collaborative care group during the same period.
Importantly, the health-related quality of life improvements were sustained in the stepped collaborative care group at 12 months (p=0.74, effect size 0.01). No adverse events were reported by patients in either group, and deaths were deemed unrelated to the study.
In conclusion, the study recommends the integrated screening and novel stepped collaborative care intervention as a superior approach to enhance health-related quality of life in cancer patients compared to the current standard of care. The findings have the potential to influence the implementation of guideline-concordant care nationwide, leading to improved outcomes for individuals diagnosed with cancer. The research was funded by the US National Cancer Institute.
This study contributes significantly to the field of oncology by demonstrating the efficacy of a comprehensive and personalized care approach in improving the quality of life for cancer patients. The integration of cognitive behavioral therapy and pharmacotherapy tailored to individual needs represents a promising strategy for addressing the complex symptoms experienced by cancer patients and enhancing their overall well-being.
Overall, the results of this trial underscore the importance of moving towards more patient-centered care models that not only focus on treating the disease but also prioritize the holistic well-being of individuals and their caregivers throughout the cancer care continuum.
(Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00015-1/fulltext)
The research was conducted in 29 oncology outpatient clinics affiliated with the UPMC Hillman Cancer Center in the USA. The participants included patients aged 21 years and older with any type of cancer and clinical levels of depression, pain, or fatigue. Family caregivers aged 21 years and older providing care to a cancer patient who consented to participate were also eligible. The patients were randomly assigned to receive stepped collaborative care or standard of care using a central, permuted block design. The treatment allocation was concealed, and the biostatistician, oncologists, and outcome assessors were blinded to the assignment.
The stepped collaborative care intervention involved weekly cognitive behavioral therapy sessions lasting 50–60 minutes delivered by a care coordinator through telemedicine platforms like telephone or videoconferencing. Additionally, pharmacotherapy for symptoms could be recommended by the treatment team or initiated based on the patient's preference. The standard of care, on the other hand, included screening patients for symptoms and referring them to healthcare providers for treatment.
The primary outcome of the study was the health-related quality of life in patients at 6 months, with the maintenance of treatment benefits assessed at 12 months. The analysis was conducted based on the intention to treat principle, which included patients with missing follow-up assessments. The study registered with ClinicalTrials.gov under the identifier NCT02939755.
Between December 2016 and April 2021, a total of 459 patients and 190 family caregivers were enrolled in the trial. Of these, 237 patients were assigned to stepped collaborative care and 222 to standard of care. The majority of patients were female (56%). Patients receiving stepped collaborative care showed a significant improvement in health-related quality of life at 0–6 months compared to those receiving standard care (p=0.013, effect size 0.09). The improvements in emotional, functional, and physical wellbeing were also greater in the stepped collaborative care group during the same period.
Importantly, the health-related quality of life improvements were sustained in the stepped collaborative care group at 12 months (p=0.74, effect size 0.01). No adverse events were reported by patients in either group, and deaths were deemed unrelated to the study.
In conclusion, the study recommends the integrated screening and novel stepped collaborative care intervention as a superior approach to enhance health-related quality of life in cancer patients compared to the current standard of care. The findings have the potential to influence the implementation of guideline-concordant care nationwide, leading to improved outcomes for individuals diagnosed with cancer. The research was funded by the US National Cancer Institute.
This study contributes significantly to the field of oncology by demonstrating the efficacy of a comprehensive and personalized care approach in improving the quality of life for cancer patients. The integration of cognitive behavioral therapy and pharmacotherapy tailored to individual needs represents a promising strategy for addressing the complex symptoms experienced by cancer patients and enhancing their overall well-being.
Overall, the results of this trial underscore the importance of moving towards more patient-centered care models that not only focus on treating the disease but also prioritize the holistic well-being of individuals and their caregivers throughout the cancer care continuum.
(Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00015-1/fulltext)
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