Improving Communication in Older Cancer Patients and Their Caregivers
- Conditions
- Adult Solid NeoplasmLymphoma
- Interventions
- Behavioral: Geriatric Assessment SummaryBehavioral: Geriatric Assessment Targeted RecommendationsBehavioral: Geriatric Assessment (GA)
- Registration Number
- NCT02107443
- Lead Sponsor
- Supriya Mohile
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 546
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I: Geriatric Assessment Intervention Geriatric Assessment Summary At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the intervention; GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose. Arm I: Geriatric Assessment Intervention Geriatric Assessment Targeted Recommendations At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the intervention; GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose. Arm I: Geriatric Assessment Intervention Geriatric Assessment (GA) At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the intervention; GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose. Arm II: Usual Care Geriatric Assessment (GA) At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided).
- Primary Outcome Measures
Name Time Method Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] Within 1-7 days of the baseline audio-recorded clinic consultation Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. HCCQ contains 7 questions, scale: 0-28. The higher the score the more satisfied the patients is with communication with their oncologists about age related concerns. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using a F test. The specific NCORP practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP.
Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified] Baseline 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. The geriatric assessment was used to define which age related topics discussed between patients and providers would be coded. We will apply linear mixed model methodology. The total number of conversations will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using a F test. The specific NCORP practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP.
- Secondary Outcome Measures
Name Time Method Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Caregiver Satisfaction With Communication About Age-related Issues. At 4-6 weeks, 3 months and 6 months following the intervention We will compare the effect of the intervention on caregiver satisfaction (the modified health care climate questionnaire (HCCQ)- age for the caregiver, range 0-20; higher score better outcome). We will apply linear mixed model methodology to compare between arm differences.
Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers. Mean 4-6 weeks, 3 months, and 6 months after the intervention Caregiver Health Related Quality of Life (burden) will be assessed with the Caregiver Reactions Assessment (CRA- \[Overall scale ranges from 1-5, better or worse outcome depending on subscale- Self Esteem Subscale higher score indicates better outcome, Disrupted Schedule subscale lower score indicates better outcome, Financial problems subscale lower score indicates better outcome, Lack of Social Support subscale lower score indicates better outcome, Health Problems subscale lower score indicates better outcome\]). We will apply linear mixed model methodology to compare between arm differences
Trial Locations
- Locations (19)
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Heartland NCORP
🇺🇸Decatur, Illinois, United States
Metro-Minnesota NCORP
🇺🇸Minneapolis, Minnesota, United States
Nevada NCORP
🇺🇸Las Vegas, Nevada, United States
Columbus NCORP
🇺🇸Columbus, Ohio, United States
Geisinger Cancer Institute NCORP
🇺🇸Danville, Pennsylvania, United States
Hawaii
🇺🇸Honolulu, Hawaii, United States
Kansas City NCORP
🇺🇸Prairie Village, Kansas, United States
Wichita NCORP
🇺🇸Wichita, Kansas, United States
University of Rochester
🇺🇸Rochester, New York, United States
Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Greenville NCORP
🇺🇸Greenville, South Carolina, United States
Delaware/Christiana Care NCORP
🇺🇸Newark, Delaware, United States
Pacific Cancer Research Consortium Ncorp
🇺🇸Portland, Oregon, United States
Aurora NCORP
🇺🇸Milwaukee, Wisconsin, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Southeast Clinical Oncology Research Consortium
🇺🇸Winston-Salem, North Carolina, United States
Northwell Health
🇺🇸Lake Success, New York, United States
WiNCORP
🇺🇸Marshfield, Wisconsin, United States