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Improving Communication in Older Cancer Patients and Their Caregivers (COACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02107443
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Results First Posted : August 28, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Supriya Mohile, University of Rochester NCORP Research Base

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) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : June 26, 2014
Actual Primary Completion Date : May 12, 2017
Estimated Study Completion Date : October 28, 2019

Resource links provided by the National Library of Medicine


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.




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] [ Time Frame: 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. 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 the Kenward-Roger small sample procedure. A 95% credible ("confidence") interval will be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using the Best Linear Unbiased Predictors (BLUP) of the mean response for each site.

  2. Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] [ Time Frame: 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 the Kenward-Roger small sample procedure. 95% credible ("confidence") interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site.


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. [ Time Frame: At 4-6 weeks, 3 months and 6 months following the intervention ]
    Patient HRQoL will be assessed with the Functional Assessment Cancer therapy (FACT-G) and Caregiver HRQoL (burden) will be assessed with the Caregiver Reactions Assessment (CRA). We will include geriatric assessment impairment (at baseline and follow up) to evaluate if these influence patient-reported HRQoL differently in the intervention versus the usual care group. We will also compare whether the uptake of the geriatric assessment recommendations influences patient reported HRQoL and caregiver burden. Data from the intervention arm will be fit to a linear mixed model with the FACT-G or CRA as the outcome, number and percent (number implemented/number recommended) of interventions as the fixed effect, and National Cancer Institute Community Oncology Research Program (NCORP) site as a random effect independent of residual error. Analyses will be adjusted for treatment status.

  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. [ Time Frame: 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-age for the caregiver). Will apply linear mixed model methodology. The total caregiver-HCCQ scores 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 the Kenward-Roger small sample procedure. A 95% credible ("confidence") interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107443


Locations
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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
United States, Delaware
Delaware/Christiana Care NCORP
Newark, Delaware, United States, 19713
United States, Hawaii
Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Heartland NCORP
Decatur, Illinois, United States, 62526
United States, Kansas
Kansas City NCORP
Prairie Village, Kansas, United States, 66208
Wichita NCORP
Wichita, Kansas, United States, 67214
United States, Michigan
Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Metro-Minnesota NCORP
Minneapolis, Minnesota, United States, 55426
United States, Nevada
Nevada NCORP
Las Vegas, Nevada, United States, 89106
United States, New York
Northwell Health
Lake Success, New York, United States, 11042
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Columbus NCORP
Columbus, Ohio, United States, 43215
United States, Oregon
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States, 97213
United States, Pennsylvania
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, United States, 17822
United States, South Carolina
Greenville NCORP
Greenville, South Carolina, United States, 29615
United States, Wisconsin
WiNCORP
Marshfield, Wisconsin, United States, 54449
Aurora NCORP
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Supriya Mohile
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Supriya Mohile University of Rochester NCORP Research Base
  Study Documents (Full-Text)

Documents provided by Supriya Mohile, University of Rochester NCORP Research Base:
Statistical Analysis Plan  [PDF] June 21, 2018
Study Protocol  [PDF] April 25, 2017


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Responsible Party: Supriya Mohile, Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT02107443     History of Changes
Other Study ID Numbers: URCC13070
NCI-2014-00619 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC 13070 ( Other Identifier: University of Rochester )
URCC-13070 ( Other Identifier: DCP )
URCC-13070 ( Other Identifier: CTEP )
UG1CA189961 ( U.S. NIH Grant/Contract )
U10CA037420 ( U.S. NIH Grant/Contract )
CD-12-11-4634 ( Other Identifier: PCORI )
First Posted: April 8, 2014    Key Record Dates
Results First Posted: August 28, 2018
Last Update Posted: February 26, 2019
Last Verified: February 2019