Adult Solid NeoplasmNCT02054741
Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
A study testing Comprehensive Geriatric Assessment, Quality-of-Life Assessment and Survey Administration in people with Adult Solid Neoplasm and Toxicity, run by Supriya Mohile at 23 sites in United States.
Trial summary
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Adult Solid Neoplasm, Toxicity, Lymphoma
- What is being tested?
- Comprehensive Geriatric Assessment, Quality-of-Life Assessment and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 733 participants
- Where
- 23 sitesUnited States
- Study dates
- 29 Jul 2014to 31 Oct 2021
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
- Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation 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. *Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) will be allowed.
- Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits
- Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
- 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 (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll.
- Participant has adequate understanding of the English language
Who cannot join
- Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
- Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Chicago
Chicago, Illinois, 60637
Columbus NCORP
Columbus, Ohio, 43215
Geisinger Cancer Institute NCORP
Danville, Pennsylvania, 17822
Dayton NCORP
Dayton, Ohio, 45420
Heartland NCORP
Decatur, Illinois, 62526
City of Hope
Duarte, California, 91010
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503
NCORP of the Carolinas
Greenville, South Carolina, 29615
Hawaii MU-NCORP
Honolulu, Hawaii, 96813
Kansas City NCORP
Kansas City, Missouri, 64131
North Shore LIJ Health System NCORP
Lake Success, New York, 11042
Nevada NCORP
Las Vegas, Nevada, 89106
Wisconsin NCORP
Marshfield, Wisconsin, 54449
Aurora NCORP
Milwaukee, Wisconsin, 53226
Metro Minnesota NCORP
Minneapolis, Minnesota, 55426
Gulf South MU-NCORP
New Orleans, Louisiana, 70112
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
Northwest NCORP
Tacoma, Washington, 98405-0986
Wichita NCORP
Wichita, Kansas, 67214
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, 27104
About this study
Official title: A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen.
SECONDARY OBJECTIVES:
- Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer.
IIA. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle).
IIB. Describe the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer.
OUTLINE: Treatment sites are randomized to 1 of 2 arms.
ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
ARM II (usual care): Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1 year.
- Conditions
- Adult Solid Neoplasm, Toxicity, Lymphoma
- Being tested
- Comprehensive Geriatric Assessment, Quality-of-Life Assessment, Survey Administration
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
Also called geriatric assessment
Complete geriatric assessment
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (GA intervention) | Experimental | Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. Receives: Other: Comprehensive Geriatric Assessment; Other: Quality-of-Life Assessment; Other: Survey Administration |
| Arm II (usual care) | No intervention | Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experienced Any Grade 3-5 Toxicity
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
Measured: 3 months
Secondary outcomes (10)
Patient Survival at 6 Months
Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method.
Measured: 6 months
Reduced Dose Intensity
Proportion of patients with reduced dose intensity in cycle 1.
Measured: 4-6 weeks
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
The type and frequency of GA-driven recommendations implemented for older patients with impaired physical performance and starting a new treatment regimen for advanced cancer. Physical Performance measures included: Timed Up and Go, Short Physical Performance Battery, Falls History, and OARS Physical Health.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
The type and frequency of GA-driven recommendations implemented for older patients with impaired functional status and starting a new treatment regimen for advanced cancer. Functional Status measures included: Activities of Daily Living and Instrumental Activities of Daily Living.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
The type and frequency of GA-driven recommendations implemented for older patients with impaired comorbidities and starting a new treatment regimen for advanced cancer. Comorbidity measure included: OARS Comorbidity.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Cognition.
The type and frequency of GA-driven recommendations implemented for older patients with impaired cognition and starting a new treatment regimen for advanced cancer. Cognition measures included: Blessed Orientation Memory Concentration and Mini Cog assessments.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
The type and frequency of GA-driven recommendations implemented for older patients with impaired nutrition and starting a new treatment regimen for advanced cancer. Nutrition measures included: Body Mass Index, Weight Loss, and Mini Nutrition Assessment.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Social Support.
The type and frequency of GA-driven recommendations implemented for older patients with impaired social support and starting a new treatment regimen for advanced cancer. Social Support measure included: OARS Medical Social Support.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
The type and frequency of GA-driven recommendations implemented for older patients with impaired polypharmacy and starting a new treatment regimen for advanced cancer. Polypharmacy measure included: medication review.
Measured: Baseline
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
The type and frequency of GA-driven recommendations implemented for older patients with impaired psychological status and starting a new treatment regimen for advanced cancer. Psychological measures included: Geriatric Depression Scale and Generalized Anxiety Disorder - 7 item scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start29 Jul 2014
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 (17)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
- None (open label)
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supriya Mohile
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Chicago, City of Hope National Medical Center
- Responsible party
- Sponsor-investigator, Supriya Mohile, University of Rochester NCORP Research Base
- Investigators
- Supriya Mohile, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054741
- Sponsor's protocol ID
- URCC13059
- Other IDs
- NCI-2013-01904, URCC13059, URCC-13059, URCC-13059, UG1CA189961, U10CA037420, R01CA177592
- Status last verified
- Apr 2024
- First submitted
- 31 Jan 2014
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mattick LJ, Mohammed M, Li CS, Tylock RG, Loh KP, Flannery MA, Peppone LJ, Lin PJ, Goncalves MD, Caan BJ, Cespedes Feliciano EM, Popuri K, Beg MF, Bearden JD, Berenberg J, Katato K, Mustian KM, Mohile SG, Dunne RF. Sarcopenia Is Associated With Severe Treatment Toxicity and Mortality in Older Adults With Advanced Cancer: A Secondary Analysis. J Cachexia Sarcopenia Muscle. 2026 Oct;17(5):e70388. doi: 10.1002/jcsm.70388.
PubMed 42782098Mohamed MR, Rich DQ, Lund JL, Seplaki CL, Flannery M, Alieldin R, Chen Y, Ramsdale E, Wells M, Magnuson A, Loh KP, Dunne R, Janelsins M, Mohile S. Treatment Tolerability in Older Adults With Advanced Cancer Receiving Geriatric Assessment-Guided Versus Oncologist-Guided Primary Treatment Modification: Secondary Analysis of the GAP70+ Trial. JCO Oncol Pract. 2026 Jul 24:OP2501364. doi: 10.1200/OP-25-01364. Online ahead of print.
PubMed 42497369Richardson DR, Wang Y, Flannery M, Mohamed M, Magnuson A, Wells M, Tylock R, Soto-Perez-de-Celis E, DuMontier C, Dale W, Epstein R, Berenberg J, Ramdin N, Mohile S, Loh KP. Outcomes of Older Adults With Advanced Cancer Who Prefer Quality of Life vs Prolonging Survival: A Secondary Analysis of the GAP70+ Cluster Randomized Clinical Trial. JAMA Oncol. 2026 May 1;12(5):517-521. doi: 10.1001/jamaoncol.2026.0072.
PubMed 41784985Hryniv S, Gilbride E, Consagra W, Mohile S, Yilmaz S, Kyi K, Kadambi S, Jensen-Battaglia M, Gilmore N, Whitehead M, Khatri J, Braiteh FS, Conlin A, Loh KP, Magnuson A. Exploring decisional control preferences in older patients with cancer and their caregivers. J Geriatr Oncol. 2026 Mar;17(2):102832. doi: 10.1016/j.jgo.2025.102832. Epub 2025 Dec 12.
PubMed 41389716Flannery MA, Zhang Z, Culakova E, Loh KP, Canin B, Tylock RG, Stauffer FA, Mohamed M, Sun H, Mohile S. Decision regret in older adults with advanced cancer receiving systemic therapy: Associations with patient-reported and clinician-rated tolerability metrics. Cancer. 2025 Oct 15;131 Suppl 2(Suppl 2):e70023. doi: 10.1002/cncr.70023.
PubMed 41123568Jensen-Battaglia M, Delmerico A, Mohamed M, Tylock R, Flannery M, Burnette BL, Desai N, Anthony N, Mustian K, Loh KP, Mohile SG, Seplaki CL, Gilmore N. Fatigue, physical function, and the context of social vulnerability for older adults with cancer. J Geriatr Oncol. 2025 Jul;16(6):102284. doi: 10.1016/j.jgo.2025.102284. Epub 2025 May 31.
PubMed 40450795Ramsdale E, Zhou Y, Smith L, Xu H, Tylock R, Flannery M, Mohile S, Anand A. Unsupervised learning to identify symptom clusters in older adults undergoing chemotherapy. J Geriatr Oncol. 2025 Apr;16(3):102222. doi: 10.1016/j.jgo.2025.102222. Epub 2025 Mar 14.
PubMed 40088865Mohamed MR, Juba K, Awad H, Flannery M, Culakova E, Wells M, Cacciatore J, Jensen-Battaglia M, Mohile S, Ramsdale E. Effect of polypharmacy and potentially inappropriate medications on physical functional decline among older adults with advanced cancer receiving systemic treatment. Support Care Cancer. 2024 Sep 19;32(10):674. doi: 10.1007/s00520-024-08877-6.
PubMed 39294452Lund 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 38564692Ramsdale E, Kunduru M, Smith L, Culakova E, Shen J, Meng S, Zand M, Anand A. Supervised learning applied to classifying fallers versus non-fallers among older adults with cancer. J Geriatr Oncol. 2023 May;14(4):101498. doi: 10.1016/j.jgo.2023.101498. Epub 2023 Apr 19.
PubMed 37084629Xu H, Mohamed M, Flannery M, Peppone L, Ramsdale E, Loh KP, Wells M, Jamieson L, Vogel VG, Hall BA, Mustian K, Mohile S, Culakova E. An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e234198. doi: 10.1001/jamanetworkopen.2023.4198.
PubMed 36947036Mohamed MR, Loh KP, Mohile SG, Sohn M, Webb T, Wells M, Yilmaz S, Tylock R, Culakova E, Magnuson A, Sun CL, Bearden J, Hopkins JO, Faller BA, Klepin HD. External Validation of Risk Factors for Unplanned Hospitalization in Older Adults With Advanced Cancer Receiving Chemotherapy. J Natl Compr Canc Netw. 2023 Mar;21(3):273-280.e3. doi: 10.6004/jnccn.2022.7094.
PubMed 36898361Mohamed MR, Mohile SG, Juba KM, Awad H, Wells M, Loh KP, Flannery M, Culakova E, Tylock RG, Ramsdale EE. Association of polypharmacy and potential drug-drug interactions with adverse treatment outcomes in older adults with advanced cancer. Cancer. 2023 Apr 1;129(7):1096-1104. doi: 10.1002/cncr.34642. Epub 2023 Jan 24.
PubMed 36692475Culakova E, Mohile SG, Peppone L, Ramsdale E, Mohamed M, Xu H, Wells M, Tylock R, Java J, Loh KP, Magnuson A, Jamieson L, Vogel V, Duberstein PR, Chapman BP, Dale W, Flannery MA. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. J Clin Oncol. 2023 Feb 1;41(4):835-846. doi: 10.1200/JCO.22.00738. Epub 2022 Nov 10.
PubMed 36356279Presley CJ, Mohamed MR, Culakova E, Flannery M, Vibhakar PH, Hoyd R, Amini A, VanderWalde N, Wong ML, Tsubata Y, Spakowicz DJ, Mohile SG. A Geriatric Assessment Intervention to Reduce Treatment Toxicity Among Older Adults With Advanced Lung Cancer: A Subgroup Analysis From a Cluster Randomized Controlled Trial. Front Oncol. 2022 Mar 31;12:835582. doi: 10.3389/fonc.2022.835582. eCollection 2022.
PubMed 35433441
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
- A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
- ClinicalTrials.gov ID
- NCT02054741
- Acronym / sponsor ID
- URCC13059
- Conditions
- Adult Solid Neoplasm, Toxicity, Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Supriya MohileUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Chicago, City of Hope National Medical Center
- Study start
- 29 Jul 2014 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen.
SECONDARY OBJECTIVES:
- Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer.
IIA. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle).
IIB. Describe the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer.
OUTLINE: Treatment sites are randomized to 1 of 2 arms.
ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
ARM II (usual care): Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (GA intervention) | Experimental | Other: Comprehensive Geriatric Assessment, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. |
| Arm II (usual care) | No intervention | –Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
- Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation 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. *Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) will be allowed.
- Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits
- Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Key exclusion criteria (2 listed)
- Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
- Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment.
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 |
|---|---|---|
| Comprehensive Geriatric AssessmentAlso: geriatric assessmentComplete geriatric assessment | Other | Arm I (GA intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (GA intervention) |
| Survey AdministrationAncillary studies | Other | Arm I (GA intervention) |
Primary outcome
Patient Experienced Any Grade 3-5 Toxicity
Time frame: 3 months
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
10 secondary outcomes
Patient Survival at 6 Months
Time frame: 6 months
Reduced Dose Intensity
Time frame: 4-6 weeks
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Time frame: Baseline
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Time frame: Baseline
Results and safety
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 42782098Mattick LJ, Mohammed M, Li CS, Tylock RG, Loh KP, Flannery MA, Peppone LJ, Lin PJ, Goncalves MD, Caan BJ, Cespedes Feliciano EM, Popuri K, Beg MF, Bearden JD, Berenberg J, Katato K, Mustian KM, Mohile SG, Dunne RF. Sarcopenia Is Associated With Severe Treatment Toxicity and Mortality in Older Adults With Advanced Cancer: A Secondary Analysis. J Cachexia Sarcopenia Muscle. 2026 Oct;17(5):e70388. doi: 10.1002/jcsm.70388.
- Derived from this study: PubMed 42497369Mohamed MR, Rich DQ, Lund JL, Seplaki CL, Flannery M, Alieldin R, Chen Y, Ramsdale E, Wells M, Magnuson A, Loh KP, Dunne R, Janelsins M, Mohile S. Treatment Tolerability in Older Adults With Advanced Cancer Receiving Geriatric Assessment-Guided Versus Oncologist-Guided Primary Treatment Modification: Secondary Analysis of the GAP70+ Trial. JCO Oncol Pract. 2026 Jul 24:OP2501364. doi: 10.1200/OP-25-01364. Online ahead of print.
- Derived from this study: PubMed 41784985Richardson DR, Wang Y, Flannery M, Mohamed M, Magnuson A, Wells M, Tylock R, Soto-Perez-de-Celis E, DuMontier C, Dale W, Epstein R, Berenberg J, Ramdin N, Mohile S, Loh KP. Outcomes of Older Adults With Advanced Cancer Who Prefer Quality of Life vs Prolonging Survival: A Secondary Analysis of the GAP70+ Cluster Randomized Clinical Trial. JAMA Oncol. 2026 May 1;12(5):517-521. doi: 10.1001/jamaoncol.2026.0072.
- Derived from this study: PubMed 41389716Hryniv S, Gilbride E, Consagra W, Mohile S, Yilmaz S, Kyi K, Kadambi S, Jensen-Battaglia M, Gilmore N, Whitehead M, Khatri J, Braiteh FS, Conlin A, Loh KP, Magnuson A. Exploring decisional control preferences in older patients with cancer and their caregivers. J Geriatr Oncol. 2026 Mar;17(2):102832. doi: 10.1016/j.jgo.2025.102832. Epub 2025 Dec 12.
- Derived from this study: PubMed 41123568Flannery MA, Zhang Z, Culakova E, Loh KP, Canin B, Tylock RG, Stauffer FA, Mohamed M, Sun H, Mohile S. Decision regret in older adults with advanced cancer receiving systemic therapy: Associations with patient-reported and clinician-rated tolerability metrics. Cancer. 2025 Oct 15;131 Suppl 2(Suppl 2):e70023. doi: 10.1002/cncr.70023.
- Derived from this study: PubMed 40450795Jensen-Battaglia M, Delmerico A, Mohamed M, Tylock R, Flannery M, Burnette BL, Desai N, Anthony N, Mustian K, Loh KP, Mohile SG, Seplaki CL, Gilmore N. Fatigue, physical function, and the context of social vulnerability for older adults with cancer. J Geriatr Oncol. 2025 Jul;16(6):102284. doi: 10.1016/j.jgo.2025.102284. Epub 2025 May 31.
- Derived from this study: PubMed 40088865Ramsdale E, Zhou Y, Smith L, Xu H, Tylock R, Flannery M, Mohile S, Anand A. Unsupervised learning to identify symptom clusters in older adults undergoing chemotherapy. J Geriatr Oncol. 2025 Apr;16(3):102222. doi: 10.1016/j.jgo.2025.102222. Epub 2025 Mar 14.
- Derived from this study: PubMed 39294452Mohamed MR, Juba K, Awad H, Flannery M, Culakova E, Wells M, Cacciatore J, Jensen-Battaglia M, Mohile S, Ramsdale E. Effect of polypharmacy and potentially inappropriate medications on physical functional decline among older adults with advanced cancer receiving systemic treatment. Support Care Cancer. 2024 Sep 19;32(10):674. doi: 10.1007/s00520-024-08877-6.
- 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 37084629Ramsdale E, Kunduru M, Smith L, Culakova E, Shen J, Meng S, Zand M, Anand A. Supervised learning applied to classifying fallers versus non-fallers among older adults with cancer. J Geriatr Oncol. 2023 May;14(4):101498. doi: 10.1016/j.jgo.2023.101498. Epub 2023 Apr 19.
- Derived from this study: PubMed 36947036Xu H, Mohamed M, Flannery M, Peppone L, Ramsdale E, Loh KP, Wells M, Jamieson L, Vogel VG, Hall BA, Mustian K, Mohile S, Culakova E. An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e234198. doi: 10.1001/jamanetworkopen.2023.4198.
- Derived from this study: PubMed 36898361Mohamed MR, Loh KP, Mohile SG, Sohn M, Webb T, Wells M, Yilmaz S, Tylock R, Culakova E, Magnuson A, Sun CL, Bearden J, Hopkins JO, Faller BA, Klepin HD. External Validation of Risk Factors for Unplanned Hospitalization in Older Adults With Advanced Cancer Receiving Chemotherapy. J Natl Compr Canc Netw. 2023 Mar;21(3):273-280.e3. doi: 10.6004/jnccn.2022.7094.
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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
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Geriatric Assessment, Quality-of-Life Assessment and Survey Administration in people with Adult Solid Neoplasm and Toxicity, run by Supriya Mohile at 23 sites in United States.
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 7 inclusion and 2 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 23 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 9 Jun 2023). 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?
Patient Experienced Any Grade 3-5 Toxicity (time frame: 3 months). 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 NCT02054741, which also lists 17 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.