COACH: Improving Communication in Older Cancer Patients and Their Caregivers

• Sponsor: Supriya Mohile (Other)
• Overall Status: Completed
• CT.gov ID: NCT02107443
• Collaborator: National Cancer Institute (NCI) (NIH), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 546
• Locations: 19
• Arms: 2
• Actual Duration (Months): 74.2
• Patients Per Site: 28.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Solid Neoplasm; Lymphoma	Behavioral: Geriatric Assessment Summary; Behavioral: Geriatric Assessment Targeted Recommendations; Behavioral: Geriatric Assessment (GA)	N/A

Detailed Description

OBJECTIVES:

1. 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]

2. 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]

3. 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.

4. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 546 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
• Actual Study Start Date: Jun 26, 2014
• Actual Primary Completion Date: May 12, 2017
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I: Geriatric Assessment Intervention 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.	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.
Active Comparator: Arm II: Usual Care At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided).	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Exclusion Criteria for Patients

• Have surgery planned within 3 months of consent. Patients who have previously received surgery are eligible.

• Have already made a decision to not undergo any cancer treatment (e.g., being followed in best supportive care or hospice).

Inclusion Criteria for Caregivers

• Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 21 or older] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient.

• If a health care proxy signs consent for or with a patient, and wants to participate in the caregiver portion of the study, this same person will always be the caregiver selected. If a health care proxy does not want to enroll as a caregiver in the study or, if enrolled, chooses to stop their own participation in the caregiver portion of the study, but is able to assist the patient in completing the study, the patient can still participate. In other words, the health care proxy can choose NOT to participate in the caregiver portion of the study. This does not preclude the patient from participating in the patient portion of the study with the health care proxy's assistance.

Exclusion Criteria for Caregivers

-Caregivers unable to understand the consent form due to cognitive, health, or sensory impairment will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
2	Delaware/Christiana Care NCORP	Newark	Delaware	United States	19713
3	Hawaii	Honolulu	Hawaii	United States	96813
4	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
5	Heartland NCORP	Decatur	Illinois	United States	62526
6	Kansas City NCORP	Prairie Village	Kansas	United States	66208
7	Wichita NCORP	Wichita	Kansas	United States	67214
8	Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
9	Metro-Minnesota NCORP	Minneapolis	Minnesota	United States	55426
10	Nevada NCORP	Las Vegas	Nevada	United States	89106
11	Northwell Health	Lake Success	New York	United States	11042
12	University of Rochester	Rochester	New York	United States	14642
13	Southeast Clinical Oncology Research Consortium	Winston-Salem	North Carolina	United States	27104
14	Columbus NCORP	Columbus	Ohio	United States	43215
15	Pacific Cancer Research Consortium Ncorp	Portland	Oregon	United States	97213
16	Geisinger Cancer Institute NCORP	Danville	Pennsylvania	United States	17822
17	Greenville NCORP	Greenville	South Carolina	United States	29615
18	WiNCORP	Marshfield	Wisconsin	United States	54449
19	Aurora NCORP	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Supriya Mohile
• National Cancer Institute (NCI)
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Supriya Mohile, University of Rochester NCORP Research Base

Study Documents (Full-Text)

• Statistical Analysis Plan - Jun 21, 2018
• Study Protocol - Apr 25, 2017

More Information

Publications

None provided.

• Responsible Party: Supriya Mohile, Professor, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT02107443
• Other Study ID Numbers: URCC13070; NCI-2014-00619; URCC 13070; URCC-13070; URCC-13070; UG1CA189961; U10CA037420; CD-12-11-4634
• First Posted: Apr 8, 2014
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

Study Results

Participant Flow

Arm/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)
Arm/Group Description	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	Patients and their caregivers (if participating) complete the GA at baseline.
Period Title: Overall Study
STARTED	296	250
COMPLETED	198	167
NOT COMPLETED	98	83

Baseline Characteristics

Arm/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)	Total
Arm/Group Description	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	Patients and their caregivers (if participating) complete the GA at baseline.	Total of all reporting groups
Overall Participants	293	248	541
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.71 (5.19)	76.41 (5.27)	76.57 (5.22)
Sex/Gender, Customized (Count of Participants)
Female	137 46.8%	127 51.2%	264 48.8%
Male	155 52.9%	121 48.8%	276 51%
Unknown	1 0.3%	0 0%	1 0.2%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	263 89.8%	219 88.3%	482 89.1%
African American	19 6.5%	21 8.5%	40 7.4%
Other	10 3.4%	8 3.2%	18 3.3%
Unknown	1 0.3%	0 0%	1 0.2%
Region of Enrollment (participants) [Number]
United States	293 100%	248 100%	541 100%
Marital Status (Count of Participants)
Single, Never Married	3 1%	4 1.6%	7 1.3%
Married	192 65.5%	148 59.7%	340 62.8%
Separated	1 0.3%	7 2.8%	8 1.5%
Domestic Partnership	2 0.7%	6 2.4%	8 1.5%
Widowed	59 20.1%	50 20.2%	109 20.1%
Divorced	35 11.9%	33 13.3%	68 12.6%
Unknown	1 0.3%	0 0%	1 0.2%
Education (Count of Participants)
Less than High School	36 12.3%	30 12.1%	66 12.2%
High School	114 38.9%	81 32.7%	195 36%
More than High School	142 48.5%	137 55.2%	279 51.6%
Unknown	1 0.3%	0 0%	1 0.2%
Cancer Type (Count of Participants)
Breast	31 10.6%	38 15.3%	69 12.8%
Gastrointestinal	72 24.6%	66 26.6%	138 25.5%
Genitourinary	46 15.7%	33 13.3%	79 14.6%
Gynecological	22 7.5%	12 4.8%	34 6.3%
Lung	78 26.6%	62 25%	140 25.9%
Lymphoma	23 7.8%	18 7.3%	41 7.6%
Other	20 6.8%	19 7.7%	39 7.2%
Unknown	1 0.3%	0 0%	1 0.2%
Cancer Stage (Count of Participants)
III	28 9.6%	19 7.7%	47 8.7%
IV	261 89.1%	219 88.3%	480 88.7%
Other	3 1%	10 4%	13 2.4%
Unknown	1 0.3%	0 0%	1 0.2%
GA Impairments (GA impairments) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [GA impairments]	4.50 (1.54)	4.45 (1.52)	4.48 (1.53)
Number of Practice Sites (participants) [Number]
Number [participants]	16 5.5%	14 5.6%	30 5.5%

Outcome Measures

1. Primary Outcome

Title	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]
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)
Arm/Group Description	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.	Patients and their caregivers (if participating) complete the GA at baseline.
Measure Participants	284	244
Least Squares Mean (95% Confidence Interval) [Number of Conversations]	8.02	4.43

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (GA Informational Intervention), Arm II (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.59
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)
Arm/Group Description	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	Patients and their caregivers (if participating) complete the GA at baseline.
Measure Participants	271	239
Least Squares Mean (95% Confidence Interval) [HCCQ total score]	23.34	22.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (GA Informational Intervention), Arm II (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.041
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

Enrolled patients who have completed the FACT-G

Arm/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)
Arm/Group Description	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.	Patients and their caregivers (if participating) complete the GA at baseline.
Measure Participants	286	241
Least Squares Mean (Standard Error) [units on a scale]	82.93 (0.71)	83.16 (0.76)

4. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)
Arm/Group Description	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.	Patients and their caregivers (if participating) complete the GA at baseline.
Measure Participants	189	158
4-6 Weeks	16.44 (0.29)	15.39 (0.31)
3 months	16.47 (0.30)	15.64 (0.32)
6 months	16.49 (0.31)	15.87 (0.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (GA Informational Intervention), Arm II (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Mixed Models Analysis
	Comments	The above p-values is for 4-6 weeks.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.12 to 1.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	The above values are for 4-6 weeks.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm I (GA Informational Intervention), Arm II (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.08
	Comments
	Method	Mixed Models Analysis
	Comments	The above p-value is for is for 3 months.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; -0.11 to 1.77
	Parameter Dispersion	Type: Value:
	Estimation Comments	The above values are for 3 months

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm I (GA Informational Intervention), Arm II (Usual Care)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Mixed Models Analysis
	Comments	The above p-value is for 6 months
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; -0.36 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments	The above values are for 6 months.

5. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

The number of caregivers with a CRA

Arm/Group Title	Arm I (GA Informational Intervention)	Arm II (Usual Care)
Arm/Group Description	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.	Patients and their caregivers (if participating) complete the GA at baseline.
Measure Participants	229	182
Self-Esteem	4.41 (0.03)	4.38 (0.03)
Disrupted Schedule	2.57 (0.05)	2.58 (0.06)
Financial Problems	1.97 (0.04)	2.04 (0.04)
Lack of Social Support	1.87 (0.04)	1.91 (0.04)
Health Problems	1.98 (0.03)	2.03 (0.04)

Adverse Events

Time Frame	Patients were followed for 6 months post-baseline during which time adverse events were collected.
Arm/Group Title	Arm I (GA Informational Intervention)		Arm II (Usual Care)
Arm/Group Description	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		Patients and their caregivers (if participating) complete the GA at baseline.
All Cause Mortality
	Arm I (GA Informational Intervention)		Arm II (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/296 (14.2%)		30/250 (12%)
Serious Adverse Events
	Arm I (GA Informational Intervention)		Arm II (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/296 (0%)		0/250 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (GA Informational Intervention)		Arm II (Usual Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/296 (0%)		0/250 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.