NCT02107443

Improving Communication in Older Cancer Patients and Their Caregivers

Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Supriya Mohile · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adult Solid Neoplasm
• Lymphoma

Interventions

Type	Name	Description
BEHAVIORAL	Geriatric Assessment Summary	Complete summary of results from the Geriatric Assessment
BEHAVIORAL	Geriatric Assessment Targeted Recommendations	Recommendations are made based on areas patients were impaired in on the Geriatric Assessment. They include referrals, tests, medication review, instructions, and support services. The choice of which recommendation to implement is left to the discretion of the physician. Treatment modifications
BEHAVIORAL	Geriatric Assessment (GA)	A GA measures the issues important to older patients, including function, psychological status, cognitive abilities, social support, and the impact of medical problems on quality of life.

Timeline

• Start date: 2014-10-27
• Primary completion: 2017-05-12
• Completion: 2020-09-01
• First posted: 2014-04-08
• Last updated: 2024-04-12
• Results posted: 2018-08-28

Locations

19 sites across 1 country: United States