Improving Communication in Older Cancer Patients and Their Caregivers
NCT ID: NCT02107443
Last Updated: 2024-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
546 participants
INTERVENTIONAL
2014-10-27
2020-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Geriatric Assessment Summary
Complete summary of results from the Geriatric Assessment
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
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.
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).
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.
Interventions
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Geriatric Assessment Summary
Complete summary of results from the Geriatric Assessment
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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).
-Caregivers unable to understand the consent form due to cognitive, health, or sensory impairment will be excluded.
70 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Patient-Centered Outcomes Research Institute
OTHER
Supriya Mohile
OTHER
Responsible Party
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Supriya Mohile
Professor
Principal Investigators
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Supriya Mohile
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Delaware/Christiana Care NCORP
Newark, Delaware, United States
Hawaii
Honolulu, Hawaii, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Heartland NCORP
Decatur, Illinois, United States
Kansas City NCORP
Prairie Village, Kansas, United States
Wichita NCORP
Wichita, Kansas, United States
Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Metro-Minnesota NCORP
Minneapolis, Minnesota, United States
Nevada NCORP
Las Vegas, Nevada, United States
Northwell Health
Lake Success, New York, United States
University of Rochester
Rochester, New York, United States
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, United States
Columbus NCORP
Columbus, Ohio, United States
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, United States
Greenville NCORP
Greenville, South Carolina, United States
WiNCORP
Marshfield, Wisconsin, United States
Aurora NCORP
Milwaukee, Wisconsin, United States
Countries
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References
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Kehoe LA, Sohn MB, Wang L, Mohile S, Kamen C, Van Orden K, Wells M, Gilmore N, Arana-Chicas E, Gudina A, Yilmez S, Griggs L, Loh KP. Associations of quality of social support and accurate beliefs about curability among older adults with advanced cancer. J Geriatr Oncol. 2024 Nov;15(8):102061. doi: 10.1016/j.jgo.2024.102061. Epub 2024 Sep 10.
Singhal S, Wang Y, Qin Z, Peterson DR, Dunne RF, Culakova E, Hopkins JO, Melnyk N, Onitilo A, Targia V, Mohile S, Loh KP. Nutritional impairment, psychological health and quality of life among older adults with advanced cancer: A secondary analysis of a randomized clinical trial. Cancer Med. 2024 Jun;13(12):e7348. doi: 10.1002/cam4.7348.
Lund JL, Cacciatore J, Tylock R, Su IH, Sharma S, Hinton SP, Smith S, Nowels MA, Chen X, Duberstein PR, Hanson LC, Mohile SG. Development and Evaluation of a Multisource Approach to Extend Mortality Follow-Up for Older Adults With Advanced Cancer Enrolled in Randomized Trials. JCO Clin Cancer Inform. 2024 Apr;8:e2300183. doi: 10.1200/CCI.23.00183.
Jensen-Battaglia M, Mohammed M, Loh KP, Wells M, Tylock R, Ramsdale E, Canin B, Geer J, O'Rourke MA, Liu JJ, Seplaki CL, Mohile SG, Wildes TM. Modifiable fall risk factors among older adults with advanced cancer: Secondary analysis of a cluster-randomized clinical trial. J Geriatr Oncol. 2023 Nov;14(8):101650. doi: 10.1016/j.jgo.2023.101650. Epub 2023 Oct 26.
Jensen-Battaglia M, Lei L, Xu H, Loh KP, Wells M, Tylock R, Ramsdale E, Kleckner AS, Mustian KM, Dunne RF, Kehoe L, Bearden J 3rd, Burnette BL, Whitehead M, Mohile SG, Wildes TM. Communication About Fall Risk in Community Oncology Practice: The Role of Geriatric Assessment. JCO Oncol Pract. 2022 Oct;18(10):e1630-e1640. doi: 10.1200/OP.22.00173. Epub 2022 Aug 19.
Jensen-Battaglia M, Lei L, Xu H, Kehoe L, Patil A, Loh KP, Ramsdale E, Magnuson A, Kleckner AS, Wildes TM, Lin PJ, Mustian KM, Giri G, Whitehead M, Bearden J 3rd, Burnette BL, Geer J, Mohile SG, Dunne RF. Association of Oncologist-Patient Communication With Functional Status and Physical Performance in Older Adults: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e223039. doi: 10.1001/jamanetworkopen.2022.3039.
Loh KP, Seplaki CL, Sanapala C, Yousefi-Nooraie R, Lund JL, Epstein RM, Duberstein PR, Flannery M, Culakova E, Xu H, McHugh C, Klepin HD, Lin PJ, Watson E, Grossman VA, Liu JJ, Geer J, O'Rourke MA, Mustian K, Mohile SG. Association of Prognostic Understanding With Health Care Use Among Older Adults With Advanced Cancer: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220018. doi: 10.1001/jamanetworkopen.2022.0018.
Gilmore N, Xu H, Kehoe L, Kleckner AS, Moorthi K, Lei L, Mohamed MRS, Loh KP, Culakova E, Flannery M, Ramsdale E, Duberstein PR, Canin B, Kamen C, Giri G, Watson E, Patil A, Onitilo AA, Burnette B, Janelsins M, Mohile SG. Evaluating the association of frailty with communication about aging-related concerns between older patients with advanced cancer and their oncologists. Cancer. 2022 Mar 1;128(5):1101-1109. doi: 10.1002/cncr.34010. Epub 2021 Nov 11.
Flannery MA, Mohile S, Culakova E, Norton S, Kamen C, Dionne-Odom JN, DiGiovanni G, Griggs L, Bradley T, Hopkins JO, Liu JJ, Loh KP. Completion of Patient-Reported Outcome Questionnaires Among Older Adults with Advanced Cancer. J Pain Symptom Manage. 2022 Feb;63(2):301-310. doi: 10.1016/j.jpainsymman.2021.07.032. Epub 2021 Aug 8.
Kleckner AS, Wells M, Kehoe LA, Gilmore NJ, Xu H, Magnuson A, Dunne RF, Jensen-Battaglia M, Mohamed MR, O'Rourke MA, Vogelzang NJ, Dib EG, Peppone LJ, Mohile SG. Using Geriatric Assessment to Guide Conversations Regarding Comorbidities Among Older Patients With Advanced Cancer. JCO Oncol Pract. 2022 Jan;18(1):e9-e19. doi: 10.1200/OP.21.00196. Epub 2021 Jul 6.
Xu H, Kadambi S, Mohile SG, Yang S, Kehoe LA, Wells M, Culakova E, Kamen C, Obrecht S, Mohamed M, Gilmore NJ, Magnuson A, Grossman VA, Hopkins JO, Geer J, Berenberg J, Mustian K, Cupertino A, Mohile N, Loh KP. Caregiving burden of informal caregivers of older adults with advanced cancer: The effects of rurality and education. J Geriatr Oncol. 2021 Sep;12(7):1015-1021. doi: 10.1016/j.jgo.2021.04.002. Epub 2021 Apr 12.
Mohile SG, Epstein RM, Hurria A, Heckler CE, Canin B, Culakova E, Duberstein P, Gilmore N, Xu H, Plumb S, Wells M, Lowenstein LM, Flannery MA, Janelsins M, Magnuson A, Loh KP, Kleckner AS, Mustian KM, Hopkins JO, Liu JJ, Geer J, Gorawara-Bhat R, Morrow GR, Dale W. Communication With Older Patients With Cancer Using Geriatric Assessment: A Cluster-Randomized Clinical Trial From the National Cancer Institute Community Oncology Research Program. JAMA Oncol. 2020 Feb 1;6(2):196-204. doi: 10.1001/jamaoncol.2019.4728.
Kehoe LA, Xu H, Duberstein P, Loh KP, Culakova E, Canin B, Hurria A, Dale W, Wells M, Gilmore N, Kleckner AS, Lund J, Kamen C, Flannery M, Hoerger M, Hopkins JO, Liu JJ, Geer J, Epstein R, Mohile SG. Quality of Life of Caregivers of Older Patients with Advanced Cancer. J Am Geriatr Soc. 2019 May;67(5):969-977. doi: 10.1111/jgs.15862. Epub 2019 Mar 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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NCI-2014-00619
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC 13070
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-13070
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-13070
Identifier Type: OTHER
Identifier Source: secondary_id
CD-12-11-4634
Identifier Type: OTHER
Identifier Source: secondary_id
URCC13070
Identifier Type: -
Identifier Source: org_study_id
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