Adult Solid Neoplasm, Lymphoma
Conditions
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.
Interventions
BEHAVIORALGeriatric Assessment Summary
Complete summary of results from the Geriatric Assessment
BEHAVIORALGeriatric 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
BEHAVIORALGeriatric 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.
Sponsors
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Supriya Mohile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Patients * Male or female 70 years of age or older * Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma. In most situations, this would be a stage IV cancer. A patient with a diagnosis of stage III cancer or lymphoma is eligible if cure is not possible or anticipated. Clinical staging without pathological confirmation of advanced disease is allowed. * Must be considering or currently receiving any kind of cancer treatment (any line), including but not limited to hormonal treatment, chemotherapy, monoclonal antibody therapy, or targeted therapy. Patients who are considering therapy are eligible even if they ultimately choose not to be on therapy. Patients with a history of any previous cancer treatment, including radiation and/or surgery are eligible. A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and
Exclusion criteria
are met. * Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy. * Have visits planned with the oncology physician for at least 3 months and be willing to come in for study visits. * Able to provide informed consent or, if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (per institutional policies) must sign consent by the baseline visit. * Subject has adequate understanding of the English language because not all GA measures have been validated in other languages.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 score over 4-6 weeks, 3 months, 6 months assessments following the intervention | 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (GA Informational Intervention) 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 | 293 |
| Arm II (Usual Care) Patients and their caregivers (if participating) complete the GA at baseline. | 248 |
| Total | 541 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 42 | 30 |
| Overall Study | Registered but Not Eligible | 0 | 1 |
| Overall Study | Study Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal: Changed MD/Facility | 1 | 3 |
| Overall Study | Withdrawal: Changed Mind | 2 | 0 |
| Overall Study | Withdrawal: Disease Progression | 4 | 2 |
| Overall Study | Withdrawal: Disliked Study Procedures | 1 | 2 |
| Overall Study | Withdrawal: Feeling Overwhelmed | 2 | 1 |
| Overall Study | Withdrawal: Hospitalization/Hospice | 28 | 28 |
| Overall Study | Withdrawal: Other Medical | 9 | 5 |
| Overall Study | Withdrawal: Personal Issues | 0 | 3 |
| Overall Study | Withdrawal: Too Many Forms | 3 | 1 |
| Overall Study | Withdrawal: Too Time Consuming | 3 | 6 |
Baseline characteristics
| Characteristic | Arm I (GA Informational Intervention) | Arm II (Usual Care) | Total |
|---|---|---|---|
| Age, Continuous | 76.71 years STANDARD_DEVIATION 5.19 | 76.41 years STANDARD_DEVIATION 5.27 | 76.57 years STANDARD_DEVIATION 5.22 |
| Cancer Stage III | 28 Participants | 19 Participants | 47 Participants |
| Cancer Stage IV | 261 Participants | 219 Participants | 480 Participants |
| Cancer Stage Other | 3 Participants | 10 Participants | 13 Participants |
| Cancer Stage Unknown | 1 Participants | 0 Participants | 1 Participants |
| Cancer Type Breast | 31 Participants | 38 Participants | 69 Participants |
| Cancer Type Gastrointestinal | 72 Participants | 66 Participants | 138 Participants |
| Cancer Type Genitourinary | 46 Participants | 33 Participants | 79 Participants |
| Cancer Type Gynecological | 22 Participants | 12 Participants | 34 Participants |
| Cancer Type Lung | 78 Participants | 62 Participants | 140 Participants |
| Cancer Type Lymphoma | 23 Participants | 18 Participants | 41 Participants |
| Cancer Type Other | 20 Participants | 19 Participants | 39 Participants |
| Cancer Type Unknown | 1 Participants | 0 Participants | 1 Participants |
| Education High School | 114 Participants | 81 Participants | 195 Participants |
| Education Less than High School | 36 Participants | 30 Participants | 66 Participants |
| Education More than High School | 142 Participants | 137 Participants | 279 Participants |
| Education Unknown | 1 Participants | 0 Participants | 1 Participants |
| GA Impairments | 4.50 GA impairments STANDARD_DEVIATION 1.54 | 4.45 GA impairments STANDARD_DEVIATION 1.52 | 4.48 GA impairments STANDARD_DEVIATION 1.53 |
| Marital Status Divorced | 35 Participants | 33 Participants | 68 Participants |
| Marital Status Domestic Partnership | 2 Participants | 6 Participants | 8 Participants |
| Marital Status Married | 192 Participants | 148 Participants | 340 Participants |
| Marital Status Separated | 1 Participants | 7 Participants | 8 Participants |
| Marital Status Single, Never Married | 3 Participants | 4 Participants | 7 Participants |
| Marital Status Unknown | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Widowed | 59 Participants | 50 Participants | 109 Participants |
| Number of Practice Sites | 16 participants | 14 participants | 30 participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 19 Participants | 21 Participants | 40 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 263 Participants | 219 Participants | 482 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 10 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 293 participants | 248 participants | 541 participants |
| Sex/Gender, Customized Gender Female | 137 Participants | 127 Participants | 264 Participants |
| Sex/Gender, Customized Gender Male | 155 Participants | 121 Participants | 276 Participants |
| Sex/Gender, Customized Gender Unknown | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 42 / 296 | 30 / 250 |
| other Total, other adverse events | 0 / 296 | 0 / 250 |
| serious Total, serious adverse events | 0 / 296 | 0 / 250 |
Outcome results
Primary
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]
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.
Time frame: Baseline
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (GA Informational Intervention) | 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] | 8.02 Number of Conversations |
| Arm II (Usual Care) | 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] | 4.43 Number of Conversations |
p-value: <0.0001Mixed Models Analysis
Primary
Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified]
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.
Time frame: Within 1-7 days of the baseline audio-recorded clinic consultation
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (GA Informational Intervention) | Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] | 23.34 HCCQ total score |
| Arm II (Usual Care) | Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] | 22.25 HCCQ total score |
p-value: 0.041Mixed Models Analysis
Secondary
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.
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.
Time frame: At 4-6 weeks, 3 months and 6 months following the intervention
Population: The number of caregiver's with an available HCCQ at 4-6 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (GA Informational Intervention) | 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. | 4-6 Weeks | 16.44 score on a scale | Standard Error 0.29 |
| Arm I (GA Informational Intervention) | 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. | 3 months | 16.47 score on a scale | Standard Error 0.3 |
| Arm I (GA Informational Intervention) | 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. | 6 months | 16.49 score on a scale | Standard Error 0.31 |
| Arm II (Usual Care) | 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. | 4-6 Weeks | 15.39 score on a scale | Standard Error 0.31 |
| Arm II (Usual Care) | 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. | 3 months | 15.64 score on a scale | Standard Error 0.32 |
| Arm II (Usual Care) | 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. | 6 months | 15.87 score on a scale | Standard Error 0.34 |
p-value: 0.0395% CI: [0.12, 1.98]Mixed Models Analysis
p-value: 0.0895% CI: [-0.11, 1.77]Mixed Models Analysis
p-value: 0.295% CI: [-0.36, 1.59]Mixed Models Analysis
Secondary
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.
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.
Time frame: Mean score over 4-6 weeks, 3 months, 6 months assessments following the intervention
Population: Enrolled patients who have completed the FACT-G
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm I (GA Informational Intervention) | 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. | 82.93 units on a scale | Standard Error 0.71 |
| Arm II (Usual Care) | 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. | 83.16 units on a scale | Standard Error 0.76 |
Secondary
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.
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
Time frame: Mean 4-6 weeks, 3 months, and 6 months after the intervention
Population: The number of caregivers with a CRA
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (GA Informational Intervention) | 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. | Disrupted Schedule | 2.57 units on a scale | Standard Error 0.05 |
| Arm I (GA Informational Intervention) | 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. | Lack of Social Support | 1.87 units on a scale | Standard Error 0.04 |
| Arm I (GA Informational Intervention) | 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. | Financial Problems | 1.97 units on a scale | Standard Error 0.04 |
| Arm I (GA Informational Intervention) | 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. | Health Problems | 1.98 units on a scale | Standard Error 0.03 |
| Arm I (GA Informational Intervention) | 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. | Self-Esteem | 4.41 units on a scale | Standard Error 0.03 |
| Arm II (Usual Care) | 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. | Health Problems | 2.03 units on a scale | Standard Error 0.04 |
| Arm II (Usual Care) | 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. | Self-Esteem | 4.38 units on a scale | Standard Error 0.03 |
| Arm II (Usual Care) | 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. | Disrupted Schedule | 2.58 units on a scale | Standard Error 0.06 |
| Arm II (Usual Care) | 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. | Financial Problems | 2.04 units on a scale | Standard Error 0.04 |
| Arm II (Usual Care) | 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. | Lack of Social Support | 1.91 units on a scale | Standard Error 0.04 |