Trial Outcomes & Findings for Improving Communication in Older Cancer Patients and Their Caregivers (NCT NCT02107443)
NCT ID: NCT02107443
Last Updated: 2024-04-12
Results Overview
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.
COMPLETED
NA
546 participants
Baseline
2024-04-12
Participant Flow
Participant milestones
| Measure |
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
|
Arm II (Usual Care)
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
296
|
250
|
|
Overall Study
COMPLETED
|
198
|
167
|
|
Overall Study
NOT COMPLETED
|
98
|
83
|
Reasons for withdrawal
| Measure |
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
|
Arm II (Usual Care)
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
Overall Study
Death
|
42
|
30
|
|
Overall Study
Study Protocol Violation
|
3
|
1
|
|
Overall Study
Registered but Not Eligible
|
0
|
1
|
|
Overall Study
Withdrawal: Hospitalization/Hospice
|
28
|
28
|
|
Overall Study
Withdrawal: Disliked Study Procedures
|
1
|
2
|
|
Overall Study
Withdrawal: Changed Mind
|
2
|
0
|
|
Overall Study
Withdrawal: Changed MD/Facility
|
1
|
3
|
|
Overall Study
Withdrawal: Too Many Forms
|
3
|
1
|
|
Overall Study
Withdrawal: Too Time Consuming
|
3
|
6
|
|
Overall Study
Withdrawal: Feeling Overwhelmed
|
2
|
1
|
|
Overall Study
Withdrawal: Other Medical
|
9
|
5
|
|
Overall Study
Withdrawal: Disease Progression
|
4
|
2
|
|
Overall Study
Withdrawal: Personal Issues
|
0
|
3
|
Baseline Characteristics
One subject did not provide demographic information in Arm I.
Baseline characteristics by cohort
| Measure |
Arm I (GA Informational Intervention)
n=293 Participants
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 II (Usual Care)
n=248 Participants
Patients and their caregivers (if participating) complete the GA at baseline.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.71 years
STANDARD_DEVIATION 5.19 • n=292 Participants • One subject did not provide demographic information in Arm I.
|
76.41 years
STANDARD_DEVIATION 5.27 • n=248 Participants • One subject did not provide demographic information in Arm I.
|
76.57 years
STANDARD_DEVIATION 5.22 • n=540 Participants • One subject did not provide demographic information in Arm I.
|
|
Sex/Gender, Customized
Gender · Female
|
137 Participants
n=293 Participants
|
127 Participants
n=248 Participants
|
264 Participants
n=541 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
155 Participants
n=293 Participants
|
121 Participants
n=248 Participants
|
276 Participants
n=541 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
1 Participants
n=293 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
263 Participants
n=293 Participants
|
219 Participants
n=248 Participants
|
482 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
19 Participants
n=293 Participants
|
21 Participants
n=248 Participants
|
40 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
10 Participants
n=293 Participants
|
8 Participants
n=248 Participants
|
18 Participants
n=541 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
1 Participants
n=293 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=541 Participants
|
|
Region of Enrollment
United States
|
293 participants
n=293 Participants
|
248 participants
n=248 Participants
|
541 participants
n=541 Participants
|
|
Marital Status
Single, Never Married
|
3 Participants
n=293 Participants
|
4 Participants
n=248 Participants
|
7 Participants
n=541 Participants
|
|
Marital Status
Married
|
192 Participants
n=293 Participants
|
148 Participants
n=248 Participants
|
340 Participants
n=541 Participants
|
|
Marital Status
Separated
|
1 Participants
n=293 Participants
|
7 Participants
n=248 Participants
|
8 Participants
n=541 Participants
|
|
Marital Status
Domestic Partnership
|
2 Participants
n=293 Participants
|
6 Participants
n=248 Participants
|
8 Participants
n=541 Participants
|
|
Marital Status
Widowed
|
59 Participants
n=293 Participants
|
50 Participants
n=248 Participants
|
109 Participants
n=541 Participants
|
|
Marital Status
Divorced
|
35 Participants
n=293 Participants
|
33 Participants
n=248 Participants
|
68 Participants
n=541 Participants
|
|
Marital Status
Unknown
|
1 Participants
n=293 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=541 Participants
|
|
Education
Less than High School
|
36 Participants
n=293 Participants
|
30 Participants
n=248 Participants
|
66 Participants
n=541 Participants
|
|
Education
High School
|
114 Participants
n=293 Participants
|
81 Participants
n=248 Participants
|
195 Participants
n=541 Participants
|
|
Education
More than High School
|
142 Participants
n=293 Participants
|
137 Participants
n=248 Participants
|
279 Participants
n=541 Participants
|
|
Education
Unknown
|
1 Participants
n=293 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=541 Participants
|
|
Cancer Type
Breast
|
31 Participants
n=293 Participants
|
38 Participants
n=248 Participants
|
69 Participants
n=541 Participants
|
|
Cancer Type
Gastrointestinal
|
72 Participants
n=293 Participants
|
66 Participants
n=248 Participants
|
138 Participants
n=541 Participants
|
|
Cancer Type
Genitourinary
|
46 Participants
n=293 Participants
|
33 Participants
n=248 Participants
|
79 Participants
n=541 Participants
|
|
Cancer Type
Gynecological
|
22 Participants
n=293 Participants
|
12 Participants
n=248 Participants
|
34 Participants
n=541 Participants
|
|
Cancer Type
Lung
|
78 Participants
n=293 Participants
|
62 Participants
n=248 Participants
|
140 Participants
n=541 Participants
|
|
Cancer Type
Lymphoma
|
23 Participants
n=293 Participants
|
18 Participants
n=248 Participants
|
41 Participants
n=541 Participants
|
|
Cancer Type
Other
|
20 Participants
n=293 Participants
|
19 Participants
n=248 Participants
|
39 Participants
n=541 Participants
|
|
Cancer Type
Unknown
|
1 Participants
n=293 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=541 Participants
|
|
Cancer Stage
III
|
28 Participants
n=293 Participants
|
19 Participants
n=248 Participants
|
47 Participants
n=541 Participants
|
|
Cancer Stage
IV
|
261 Participants
n=293 Participants
|
219 Participants
n=248 Participants
|
480 Participants
n=541 Participants
|
|
Cancer Stage
Other
|
3 Participants
n=293 Participants
|
10 Participants
n=248 Participants
|
13 Participants
n=541 Participants
|
|
Cancer Stage
Unknown
|
1 Participants
n=293 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=541 Participants
|
|
GA Impairments
|
4.50 GA impairments
STANDARD_DEVIATION 1.54 • n=293 Participants
|
4.45 GA impairments
STANDARD_DEVIATION 1.52 • n=248 Participants
|
4.48 GA impairments
STANDARD_DEVIATION 1.53 • n=541 Participants
|
|
Number of Practice Sites
|
16 participants
n=293 Participants
|
14 participants
n=248 Participants
|
30 participants
n=541 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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).
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.
Outcome measures
| Measure |
Arm I (GA Informational Intervention)
n=284 Participants
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 II (Usual Care)
n=244 Participants
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
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
Interval 7.09 to 8.94
|
4.43 Number of Conversations
Interval 3.42 to 5.44
|
PRIMARY outcome
Timeframe: Within 1-7 days of the baseline audio-recorded clinic consultationPopulation: 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).
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.
Outcome measures
| Measure |
Arm I (GA Informational Intervention)
n=271 Participants
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 II (Usual Care)
n=239 Participants
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified]
|
23.34 HCCQ total score
Interval 22.63 to 24.05
|
22.25 HCCQ total score
Interval 21.49 to 23.01
|
SECONDARY outcome
Timeframe: Mean score over 4-6 weeks, 3 months, 6 months assessments following the interventionPopulation: Enrolled patients who have completed the FACT-G
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.
Outcome measures
| Measure |
Arm I (GA Informational Intervention)
n=286 Participants
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 II (Usual Care)
n=241 Participants
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
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
|
83.16 units on a scale
Standard Error 0.76
|
SECONDARY outcome
Timeframe: At 4-6 weeks, 3 months and 6 months following the interventionPopulation: The number of caregiver's with an available HCCQ at 4-6 weeks
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.
Outcome measures
| Measure |
Arm I (GA Informational Intervention)
n=189 Participants
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 II (Usual Care)
n=158 Participants
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
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
|
15.39 score on a scale
Standard Error 0.31
|
|
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
|
15.87 score on a scale
Standard Error 0.34
|
|
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 0.30
|
15.64 score on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Mean 4-6 weeks, 3 months, and 6 months after the interventionPopulation: The number of caregivers with a CRA
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
Outcome measures
| Measure |
Arm I (GA Informational Intervention)
n=229 Participants
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 II (Usual Care)
n=182 Participants
Patients and their caregivers (if participating) complete the GA at baseline.
|
|---|---|---|
|
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
|
4.38 units on a scale
Standard Error 0.03
|
|
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
|
2.58 units on a scale
Standard Error 0.06
|
|
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
|
2.04 units on a scale
Standard Error 0.04
|
|
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
|
1.91 units on a scale
Standard Error 0.04
|
|
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
|
2.03 units on a scale
Standard Error 0.04
|
Adverse Events
Arm I (GA Informational Intervention)
Arm II (Usual Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Supriya Mohile, Professor of Medicine
University of Rochester, Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place