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Brief Title: Improving Communication in Older Cancer Patients and Their Caregivers
Official Title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Study ID: NCT02107443
Brief Summary: Over 60% of cancers occur in older persons, and the number of older persons with cancer is expected to grow as the population ages. Oncology clinical trials have traditionally excluded older patients with advanced cancer and chronic health conditions. In this context, where data is limited and risk from treatment is high, older patients with advanced cancer and their caregivers must understand how cancer treatment can affect quality of life in light of underlying health status. Better communication about age-related health conditions between oncologists, older patients with advanced cancer, and their caregivers may improve decision-making for cancer treatment and quality of life. A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. In this cluster randomized clinical trial we examined whether providing a web-generated GA summary with targeted recommendations to older patients with advanced cancer, their caregivers, and their oncologists can improve communication about age-related concerns that could affect efficacy and tolerance of cancer treatment. We also determined whether the intervention improves patient-reported quality of life and patient and caregiver satisfaction.
Detailed Description: OBJECTIVES: I. Primary Aim - Direct Communication about Age-related Concerns: To determine if providing GA summary plus GA-driven recommendations to patients, their caregivers, and oncology physicians increases discussions about age-related issues during clinic consultation. \[Patient-Centered Outcomes Research Institute (PCORI) specified\] II. Primary Aim - Patient Satisfaction with Communication about Age-related Concerns: To determine if providing geriatric assessment (GA) summary plus GA-driven recommendations to patients, their caregivers and oncology physicians improves patient satisfaction with communication with the oncology physician regarding age-related concerns. \[National Cancer Institute (NCI) specified\] III. Secondary Aim - To determine whether initially providing patients, their caregivers, and oncology physicians with GA summary plus GA-driven recommendations prior to their treatment influences quality of life of older patients receiving treatment and their caregivers. IV. Secondary Aim - To determine whether providing patients, their caregivers, and oncology physicians with GA summary plus GA-driven recommendations influences caregiver satisfaction with communication about age-related issues. OUTLINE: Patients are randomized to 1 of 2 arms. Arm I: At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose. Arm II: At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided). Patients are followed at 4-6 weeks, 3 months, and 6 months. Survival data will be collected at 1 year after enrollment.
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Delaware/Christiana Care NCORP, Newark, Delaware, United States
Hawaii, Honolulu, Hawaii, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Heartland NCORP, Decatur, Illinois, United States
Kansas City NCORP, Prairie Village, Kansas, United States
Wichita NCORP, Wichita, Kansas, United States
Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Metro-Minnesota NCORP, Minneapolis, Minnesota, United States
Nevada NCORP, Las Vegas, Nevada, United States
Northwell Health, Lake Success, New York, United States
University of Rochester, Rochester, New York, United States
Southeast Clinical Oncology Research Consortium, Winston-Salem, North Carolina, United States
Columbus NCORP, Columbus, Ohio, United States
Pacific Cancer Research Consortium Ncorp, Portland, Oregon, United States
Geisinger Cancer Institute NCORP, Danville, Pennsylvania, United States
Greenville NCORP, Greenville, South Carolina, United States
WiNCORP, Marshfield, Wisconsin, United States
Aurora NCORP, Milwaukee, Wisconsin, United States
Name: Supriya Mohile
Affiliation: University of Rochester NCORP Research Base
Role: PRINCIPAL_INVESTIGATOR