Adult Solid NeoplasmCOACHNCT02107443

Improving Communication in Older Cancer Patients and Their Caregivers

A study testing Geriatric Assessment Summary, Geriatric Assessment Targeted Recommendations and Geriatric Assessment (GA) in people with Adult Solid Neoplasm and Lymphoma, run by Supriya Mohile at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for: Adult Solid Neoplasm, Lymphoma
What is being tested?: Geriatric Assessment Summary, Geriatric Assessment Targeted Recommendations and Geriatric Assessment (GA)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 546 participants
Where: 19 sitesUnited States
Study dates: 27 Oct 2014to 1 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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.

Show all 9Show fewer

Subject has adequate understanding of the English language because not all GA measures have been validated in other languages.
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.

Who cannot join

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.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Columbus NCORP
Columbus, Ohio, 43215
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, 17822
Heartland NCORP
Decatur, Illinois, 62526
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Greenville NCORP
Greenville, South Carolina, 29615
Hawaii
Honolulu, Hawaii, 96813
Northwell Health
Lake Success, New York, 11042
Nevada NCORP
Las Vegas, Nevada, 89106
WiNCORP
Marshfield, Wisconsin, 54449
Aurora NCORP
Milwaukee, Wisconsin, 53226
Metro-Minnesota NCORP
Minneapolis, Minnesota, 55426
Delaware/Christiana Care NCORP
Newark, Delaware, 19713
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, 97213
Kansas City NCORP
Prairie Village, Kansas, 66208
University of Rochester
Rochester, New York, 14642
Wichita NCORP
Wichita, Kansas, 67214
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers

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.

Read the detailed description

OBJECTIVES:

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: Adult Solid Neoplasm, Lymphoma
Being tested: Geriatric Assessment Summary, Geriatric Assessment Targeted Recommendations, Geriatric Assessment (GA)
Medical subject headings: Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Geriatric Assessment SummaryBehavioural
Complete summary of results from the Geriatric Assessment
Geriatric Assessment Targeted RecommendationsBehavioural
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)Behavioural
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.

Study groups in NCT02107443
Study group	Role	What they receive
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. Receives: 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). Receives: Behavioral: Geriatric Assessment (GA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 20141 Sep 2020

First posted8 Apr 2014 (estimated)
Study start27 Oct 2014
Primary completion12 May 2017
Study completion1 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Adult Solid NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 546 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02107443
Sponsor's protocol ID: URCC13070
Other IDs: NCI-2014-00619, URCC 13070, URCC-13070, URCC-13070, UG1CA189961, U10CA037420, CD-12-11-4634
Acronym: COACH
Status last verified: Apr 2024
First submitted: 3 Apr 2014
Last updated: 12 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 39260086
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.
PubMed 38898664
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.
PubMed 38564692
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.
PubMed 37897888
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.
PubMed 35984998
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.
PubMed 35302628
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.
PubMed 35179585
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.
PubMed 34762734
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.
PubMed 34371137
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.
PubMed 34228510
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.
PubMed 33858803
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.
PubMed 31697365
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.
PubMed 30924548

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
ClinicalTrials.gov ID: NCT02107443
Acronym / sponsor ID: COACH / URCC13070
Conditions: Adult Solid Neoplasm, Lymphoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 546 participants (actual)
Lead sponsor: Supriya MohileUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute
Study start: 27 Oct 2014 (actual)
Primary completion: 12 May 2017 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 28 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

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]

OUTLINE: Patients are randomized to 1 of 2 arms.

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

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm I: Geriatric Assessment Intervention	Experimental	Behavioral: Geriatric Assessment Summary, Behavioral: Geriatric Assessment Targeted Recommendations, Behavioral: Geriatric Assessment (GA)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.
Arm II: Usual Care	Active comparator	Behavioral: Geriatric Assessment (GA)At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided).

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Geriatric Assessment SummaryComplete summary of results from the Geriatric Assessment	Behavioural	Arm I: Geriatric Assessment Intervention
Geriatric Assessment Targeted RecommendationsRecommendations 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	Behavioural	Arm I: Geriatric Assessment Intervention
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.	Behavioural	Arm I: Geriatric Assessment Intervention, Arm II: Usual Care

Primary outcome

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. 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.
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 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.

3 secondary outcomes

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: 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.
Time frame: 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.
Time frame: Mean 4-6 weeks, 3 months, and 6 months after the intervention

Results and safety

Results posted to the registry on 28 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (GA Informational Intervention)	296	198
Arm II (Usual Care)	250	167

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: Number of Conversations

Measure	Arm I (GA Informational Intervention) n = 284	Arm II (Usual Care) n = 244
Value	8.02 (7.09 to 8.94)	4.43 (3.42 to 5.44)

Arm I (GA Informational Intervention) vs Arm II (Usual Care): Mean Difference (Final Values): 3.59, p <0.0001, Mixed Models Analysis

Population analysed: 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).

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: HCCQ total score

Measure	Arm I (GA Informational Intervention) n = 271	Arm II (Usual Care) n = 239
Value	23.34 (22.63 to 24.05)	22.25 (21.49 to 23.01)

Arm I (GA Informational Intervention) vs Arm II (Usual Care): Mean Difference (Final Values): 1.09, p = 0.041, Mixed Models Analysis

Population analysed: 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).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were followed for 6 months post-baseline during which time adverse events were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (GA Informational Intervention)	0 of 296 (0%)	0 of 296 (0%)	42 of 296
Arm II (Usual Care)	0 of 250 (0%)	0 of 250 (0%)	30 of 250

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39260086Kehoe 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.
Derived from this study: PubMed 38898664Singhal 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.
Derived from this study: PubMed 38564692Lund 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.
Derived from this study: PubMed 37897888Jensen-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.
Derived from this study: PubMed 35984998Jensen-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.
Derived from this study: PubMed 35302628Jensen-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.
Derived from this study: PubMed 35179585Loh 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.
Derived from this study: PubMed 34762734Gilmore 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.
Derived from this study: PubMed 34371137Flannery 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.
Derived from this study: PubMed 34228510Kleckner 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.
Derived from this study: PubMed 33858803Xu 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.
Derived from this study: PubMed 31697365Mohile 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.
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data ArchiveLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Supriya Mohile principal investigator

University of Rochester NCORP Research Base

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107443, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.