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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-01760 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC-19178 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-19178 | Other Identifier | DCP | |
| URCC-19178 | Other Identifier | CTEP | |
| R01CA249467 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase III trial compares the effect of geriatric evaluation and management with survivorship health education (GEM-S) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEM-S may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEM-S in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.
PRIMARY OBJECTIVE:
I. To assess the efficacy of GEM-S for improving patient-reported physical function (Functional Assessment of Chronic Illness-Fatigue Physical Well-Being Subscale [FACIT-PWB]) in older cancer survivors at 6 months. (Survivor Aim)
SECONDARY OBJECTIVE:
I. To assess the efficacy of GEM-S for improving patient-reported cognitive function (Functional Assessment of Cancer Therapy [FACT]-cognitive function [Cog]) in older cancer survivors at 6 months.
TERTIARY OBJECTIVES:
I. To assess the preliminary efficacy of GEM-S for improving:
Ia. Objective physical function (6-minute walk test) in older cancer survivors at 6 months; Ib. Objective cognitive function (Objective Cognitive Tests-Trail Making Part A/B [TMT A/B] and Controlled Oral Word Association [COWA] [i.e., FAS Test]) in older cancer survivors at 6 months.
EXPLORATORY HEALTH CARE OBJECTIVES:
I. To explore the preliminary efficacy of GEM-S for improving:
Ia. Survivor satisfaction with care (Health Care Climate Questionnaire [HCCQ] and communication about aging) at 6 months; Ib. Care coordination (# of contacts for co-management) up to 6 months; Ic. Survivor completion of referral appointments (# completed/# referrals) up to 6 months.
EXPLORATORY CAREGIVER OBJECTIVES:
I. To explore the preliminary efficacy of GEM-S for improving:
Ia. Caregiver distress (Distress Thermometer) at 6 months; Ib. Caregiver quality of life (Caregiver Quality of Life Index) at 6 months; Ic. Satisfaction with care (Health Care Climate Questionnaire [HCCQ] and communication about aging) at 6 months.
OUTLINE: Practice sites are randomized to 1 of 2 arms. Participants are assigned to arms based on practice site.
ARM I: Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study.
ARM II: Survivors and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Both survivors and caregivers also participate in survivorship health education (SHE) sessions over 75 minutes twice weekly for 4 weeks. Survivors and caregivers also participate in Exercise for Cancer Patients (EXCAP) program, which includes daily walking and resistance exercises.
After completion of study intervention, participants are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study. |
|
| Arm II (GEMS intervention) | Experimental | Survivors and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Both survivors and caregivers also participate in SHE sessions over 75 minutes twice weekly for 4 weeks. Survivors and caregivers also participate in EXCAP program, which includes daily walking and resistance exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual follow-up survivorship care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported physical function | Will be assessed by the Functional Assessment of Cancer Therapy Physical Well-Being (FACIT-PWB) Subscale in older cancer survivors. The FACIT-PWB is 7-items as part of a larger 40-item FACIT-F questionnaire. Each question uses a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported cognitive function | Will be assessed by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) Function in older cancer survivors. The FACT-Cog is a 37-item questionnaire, each with a 5-point Likert scale response. The FACT-Cog provides an overall score and subdomain scores (perceived cognitive impairment [PCI], perceived abilities, comments from others, and impact on quality of life). The secondary aim will be the PCI score at 6 months. |
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Inclusion Criteria:
PRACTICE CRITERIA: Participating practice clusters will be required to identify one (or more) oncologist and/or advanced practice practitioner (APPs; i.e., nurse practitioners, or physician assistants) as part of study eligibility. If another clinician is interested in participating, please contact University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base (RB) for approval
PRACTICE CRITERIA: Support/buy-in from oncology physicians and/or APPs and/or other clinicians who are willing to participate in training and study procedures and enroll cancer survivors
ENTRY CRITERIA FOR ONCOLOGY PHYSICIANS/APPS/OTHER CLINICIANS: Oncology physicians/APPs/other clinicians must work at a participating site with no plans to leave that practice or retire within one year of enrollment into the study. We do not require that any or all oncology physicians and/or APPs at a practice setting agree to participate. Only one clinician is required for the practice cluster to be eligible. If another clinician (other than oncology physician or APP) is interested in participating, please contact URCC NCORP RB for approval
CANCER SURVIVORS: 65 years or older
CANCER SURVIVORS: Have completed or will have completed curative-intent treatment (e.g., surgery, chemotherapy, chemotherapy with radiation) for any solid tumor or lymphoma malignancy in last 6 months. If the survivor is receiving curative-intent chemotherapy, run-in study procedures can occur during the last 6 weeks of chemotherapy.
CANCER SURVIVORS: Be willing and able to come in for study visits or willing to undergo informed consent and assessments remotely via tele-health visits
CANCER SURVIVORS: Be willing and able to provide informed consent and must sign consent in-person or remotely if it is not convenient or feasible to provide informed consent in-person
CANCER SURVIVORS: Speak and understand English and/or Spanish. Spanish-speaking cancer survivors are eligible as long as there are appropriate resources in place for completion of study procedures at the practice site. Registration for Spanish-speaking cancer survivors must be approved by the URCC NCORP Research Base after a phone call to determine the feasibility for the practice to enroll a Spanish-speaking participant
CAREGIVERS: 18 years or older
CAREGIVERS: Selected by the cancer survivor when asked if there is a "family member, partner, friend or caregiver (age 18 years or older) with whom you discuss or who can be helpful in health-related matters." A caregiver need not be someone who lives with the cancer survivor or provides direct hands-on care
CAREGIVERS: Speak and understand English and/or Spanish. Spanish-speaking caregivers are eligible as long as there are appropriate resources in place for completion of study procedures. Registration for Spanish-speaking caregivers must be approved by the URCC NCORP Research Base after a phone call to determine the feasibility for the practice to enroll a Spanish-speaking participant
Exclusion Criteria:
CANCER SURVIVORS: Have a condition that precludes their ability to participate in informed consent or procedures (e.g., dementia)
CAREGIVERS: Caregivers unable to understand the informed consent form or study procedures due to cognitive, health, or sensory impairment will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Supriya G Mohile | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lewis and Faye Manderson Cancer Center | Recruiting | Tuscaloosa | Alabama | 35401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35292232 | Derived | Yilmaz S, Janelsins MC, Flannery M, Culakova E, Wells M, Lin PJ, Loh KP, Epstein R, Kamen C, Kleckner AS, Norton SA, Plumb S, Alberti S, Doyle K, Porto M, Weber M, Dukelow N, Magnuson A, Kehoe LA, Nightingale G, Jensen-Battaglia M, Mustian KM, Mohile SG. Protocol paper: Multi-site, cluster-randomized clinical trial for optimizing functional outcomes of older cancer survivors after chemotherapy. J Geriatr Oncol. 2022 Jul;13(6):892-903. doi: 10.1016/j.jgo.2022.03.001. Epub 2022 Mar 12. |
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| Comprehensive Geriatric Assessment | Other | Complete geriatric assessment |
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| Educational Intervention | Other | Participate in survivorship health education sessions |
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| Exercise Intervention | Other | Participate in SHE-EXCAP program |
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| Questionnaire Administration | Other | Ancillary studies |
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| Tailored Intervention | Procedure | Participate in GEM consultation |
|
| Up to 6 months |
| Kaiser Permanente-Fremont | Recruiting | Fremont | California | 94538 | United States |
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| Kaiser Permanente-San Francisco | Recruiting | San Francisco | California | 94115 | United States |
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| Helen F Graham Cancer Center | Recruiting | Newark | Delaware | 19713 | United States |
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| Medical Oncology Hematology Consultants PA | Recruiting | Newark | Delaware | 19713 | United States |
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| Hawaii Cancer Care Inc - Waterfront Plaza | Recruiting | Honolulu | Hawaii | 96813 | United States |
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| Straub Clinic and Hospital | Recruiting | Honolulu | Hawaii | 96813 | United States |
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| Kapiolani Medical Center for Women and Children | Recruiting | Honolulu | Hawaii | 96826 | United States |
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| Tripler Army Medical Center | Recruiting | Honolulu | Hawaii | 96859 | United States |
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| Hawaii Cancer Care - Westridge | Recruiting | ‘Aiea | Hawaii | 96701 | United States |
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| Pali Momi Medical Center | Recruiting | ‘Aiea | Hawaii | 96701 | United States |
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| OSF Saint Anthony's Health Center | Recruiting | Alton | Illinois | 62002 | United States |
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| Fairview Southdale Hospital | Recruiting | Edina | Minnesota | 55435 | United States |
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| Hennepin County Medical Center | Recruiting | Minneapolis | Minnesota | 55415 | United States |
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| Monticello Cancer Center | Recruiting | Monticello | Minnesota | 55362 | United States |
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| Park Nicollet Clinic - Saint Louis Park | Recruiting | Saint Louis Park | Minnesota | 55416 | United States |
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| Regions Hospital | Recruiting | Saint Paul | Minnesota | 55101 | United States |
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| Lakeview Hospital | Recruiting | Stillwater | Minnesota | 55082 | United States |
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| Rice Memorial Hospital | Recruiting | Willmar | Minnesota | 56201 | United States |
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| Minnesota Oncology Hematology PA-Woodbury | Recruiting | Woodbury | Minnesota | 55125 | United States |
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| Lake Regional Hospital | Recruiting | Osage Beach | Missouri | 65065 | United States |
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| Noyes Memorial Hospital/Myers Cancer Center | Recruiting | Dansville | New York | 14437 | United States |
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| Northwell Health/Center for Advanced Medicine | Recruiting | Lake Success | New York | 11042 | United States |
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| Highland Hospital | Recruiting | Rochester | New York | 14620 | United States |
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| Pluta Cancer Center | Recruiting | Rochester | New York | 14623 | United States |
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| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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| Wilmot Cancer Institute at Webster | Recruiting | Webster | New York | 14580 | United States |
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| Novant Health Breast Surgery - Greensboro | Recruiting | Greensboro | North Carolina | 27403 | United States |
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| Novant Health Cancer Institute - Kernersville | Recruiting | Kernersville | North Carolina | 27284 | United States |
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| Novant Health Cancer Institute - Mount Airy | Recruiting | Mount Airy | North Carolina | 27030 | United States |
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| Novant Health Cancer Institute - Statesville | Recruiting | Stateville | North Carolina | 28625 | United States |
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| Novant Health Cancer Institute - Thomasville | Recruiting | Thomasville | North Carolina | 27360 | United States |
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| Novant Health Forsyth Medical Center | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| South Central Medical and Resource Center | Recruiting | Lindsay | Oklahoma | 73052 | United States |
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| Geisinger Medical Center | Recruiting | Danville | Pennsylvania | 17822 | United States |
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| Geisinger Cancer Center Dickson City | Recruiting | Dickson City | Pennsylvania | 18519 | United States |
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| Community Medical Center | Recruiting | Scranton | Pennsylvania | 18510 | United States |
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| Geisinger Wyoming Valley/Henry Cancer Center | Recruiting | Wilkes-Barre | Pennsylvania | 18711 | United States |
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| Chesapeake Regional Medical Center | Recruiting | Chesapeake | Virginia | 23320 | United States |
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| ThedaCare Regional Cancer Center | Recruiting | Appleton | Wisconsin | 54911 | United States |
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| HSHS Sacred Heart Hospital | Suspended | Eau Claire | Wisconsin | 54701 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Recruiting | Green Bay | Wisconsin | 54301 | United States |
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| Saint Vincent Hospital Cancer Center at Saint Mary's | Recruiting | Green Bay | Wisconsin | 54303 | United States |
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| Marshfield Medical Center-River Region at Stevens Point | Recruiting | Stevens Point | Wisconsin | 54482 | United States |
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| Marshfield Medical Center - Weston | Recruiting | Weston | Wisconsin | 54476 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D015577 | Geriatric Assessment |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
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