Improving Communication in Older Cancer Patients and Their Caregivers

NCT02107443 | Completed Results DMC

• 7 other identifiers: URCC13070NCI-2014-00619URCC 13070URCC-13070UG1CA189961U10CA037420CD-12-11-4634
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 19

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.

Conditions

Adult Solid Neoplasm; Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  Within 1-7 days of the baseline audio-recorded clinic consultation

Secondary Outcomes (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 score over 4-6 weeks, 3 months, 6 months assessments following the 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.

  At 4-6 weeks, 3 months and 6 months following the 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.

  Mean 4-6 weeks, 3 months, and 6 months after the intervention

Study Arms (2)

Arm I: Geriatric Assessment Intervention

EXPERIMENTAL

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; Behavioral: Geriatric Assessment Targeted Recommendations; Behavioral: Geriatric Assessment (GA)

Arm II: Usual Care

ACTIVE COMPARATOR

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)

Interventions

Geriatric Assessment Summary BEHAVIORAL

Complete summary of results from the Geriatric Assessment

Arm I: Geriatric Assessment Intervention

Geriatric Assessment Targeted Recommendations BEHAVIORAL

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

Arm I: Geriatric Assessment Intervention

Geriatric Assessment (GA) BEHAVIORAL

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 I: Geriatric Assessment Intervention; Arm II: Usual Care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (19)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Delaware/Christiana Care NCORP

Newark, Delaware, 19713, United States

Location

Hawaii

Honolulu, Hawaii, 96813, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Heartland NCORP

Decatur, Illinois, 62526, United States

Location

Kansas City NCORP

Prairie Village, Kansas, 66208, United States

Location

Wichita NCORP

Wichita, Kansas, 67214, United States

Location

Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Metro-Minnesota NCORP

Minneapolis, Minnesota, 55426, United States

Location

Nevada NCORP

Las Vegas, Nevada, 89106, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Southeast Clinical Oncology Research Consortium

Winston-Salem, North Carolina, 27104, United States

Location

Columbus NCORP

Columbus, Ohio, 43215, United States

Location

Pacific Cancer Research Consortium Ncorp

Portland, Oregon, 97213, United States

Location

Geisinger Cancer Institute NCORP

Danville, Pennsylvania, 17822, United States

Location

Greenville NCORP

Greenville, South Carolina, 29615, United States

Location

WiNCORP

Marshfield, Wisconsin, 54449, United States

Location

Aurora NCORP

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (13)

• 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.

  PMID: 39260086 DERIVED

• 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.

  PMID: 38898664 DERIVED

• 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.

  PMID: 38564692 DERIVED

• 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.

  PMID: 37897888 DERIVED

• 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.

  PMID: 35984998 DERIVED

• 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.

  PMID: 35302628 DERIVED

• 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.

  PMID: 35179585 DERIVED

• 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.

  PMID: 34762734 DERIVED

• 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.

  PMID: 34371137 DERIVED

• 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.

  PMID: 34228510 DERIVED

• 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.

  PMID: 33858803 DERIVED

• 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.

  PMID: 31697365 DERIVED

• 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.

  PMID: 30924548 DERIVED

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

MeSH Terms

Conditions

Lymphoma

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Supriya Mohile, Professor of Medicine
• Organization: University of Rochester, Medical Center

URCC_COACH@URMC.Rochester.edu

585-275-0394

Study Officials

• Supriya Mohile

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: October 27, 2014
• Primary Completion: May 12, 2017
• Study Completion: September 1, 2020
• Last Updated: April 12, 2024
• Results First Posted: August 28, 2018

Record last verified: 2024-04

Locations

US (19)