Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphosarcoma

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.

At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided).

Complete summary of results from the Geriatric Assessment

Geriatric Assessment Summary

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

Geriatric Assessment Targeted Recommendations

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.

Geriatric Assessment (GA)

Supriya Mohile

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.

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.

Improving Communication in Older Cancer Patients and Their Caregivers

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

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.

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.

Patient Health Related Quality of Life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-General (FACT-G) measured on a 0-108 scale with higher scores indicating a better outcome. We will apply linear mixed model methodology to compare the between arm differences.

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.

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

National Cancer Institute (NCI)

Patient-Centered Outcomes Research Institute

Professor

Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.

Informational Intervention: Complete GA summary plus GA-driven recommendations

Arm I (GA Informational Intervention)

Patients and their caregivers (if participating) complete the GA at baseline.

Arm II (Usual Care)

Total

One subject did not provide demographic information in Arm I.

Age, Continuous

Gender

Sex/Gender, Customized

Race/Ethnicity

Race/Ethnicity, Customized

United States

Region of Enrollment

Marital Status

Education

Cancer Type

A diagnosis of advanced solid, incurable stage III or IV cancer was part of the eligibility criteria. Clinical staging without pathological confirmation of advanced disease was allowed. Cancer stage was collected on the "Tumor \& Treatment Characteristics" measure which is completed at baseline by the clinical research associate under the direction of the oncology physician.

Cancer Stage

There are 8 different GA domains in which impairments are measured, they include psychological status, cognition, social support, functional status, nutrition, co-morbidity, polypharmacy, and physical performance. The total number of GA-domain impairments were calculated. The total number of possible impairments range from 1-8 (patients had to have at least 1 GA impairment to be eligible for the study).

GA Impairments

Number of Practice Sites

* Non-Evaluable Patients: Arm I- 3 Patients Study Protocol Violation; Arm II- 1 Patient Study Protocol Violation, 1 Patient Registered then found to be ineligible.
* Missing Demographics information from 1 evaluable patient from Arm I. This is denoted as Unknown.

Dr. Supriya Mohile, Professor of Medicine

Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline.

Informational Intervention:Complete GA summary plus GA-driven recommendations.

All baseline patients who were evaluable for this primary aim were included in this analysis.

* Arm I patients excluded because 2 withdrew, 1 expired, 4 no audio captured and 2 primary aim protocol violations.
* Arm II patients excluded (3 withdrew, 1 no audio captured).

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]

All baseline patients who were evaluable for this primary aim were included in this analysis.

* Arm I patients excluded (2 patients withdrew, 19 patients with no HCCQ).
* Arm II patients excluded (3 patients withdrew, 9 no HCCQ).

Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified]

Enrolled patients who have completed the FACT-G

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.

4-6 Weeks

3 months

6 months

The number of caregiver's with an available HCCQ at 4-6 weeks

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Improving Communication in Older Cancer Patients and Their Caregivers	NCT02107443	Adult Solid Neo... Lymphoma	Geriatric Asses... Geriatric Asses... Geriatric Asses...	70 Years -	University of Rochester
Improving Communication in Older Cancer Patients and Their Caregivers	NCT02107443	Adult Solid Neo... Lymphoma	Geriatric Asses... Geriatric Asses... Geriatric Asses...	70 Years -	University of Rochester

Spots Global Cancer Trial Database for geriatric assessment summary