LymphomaPhase 3GEM-SNCT05006482
Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
A Phase 3 study testing Best Practice, Comprehensive Geriatric Assessment and Educational Intervention in people with Lymphoma and Malignant Solid Neoplasm, run by University of Rochester at 45 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Comprehensive Geriatric Assessment and Educational Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 45 sitesUnited States
- Study dates
- 21 Mar 2023to 17 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Oncologists/APPs/other clinicians must be licensed to practice
- Oncologists/APPs/other clinicians must not have a plan to leave or retire from the NCORP practice within one year of enrolling into the study
- 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
Show all 15Show fewer
- 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 who will receive or are receiving other treatments (e.g., hormonal treatment, monoclonal antibodies, immunotherapy, radiation) are eligible
- For patients receiving neoadjuvant chemotherapy for curative intent, the run-in and baseline procedures can occur before or after surgery. Patients should be enrolled within 6 months from the end of surgery
- 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
Who cannot join
- 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
- Capacity to conduct informed consent procedures and study procedures will be determined by the coordinators in collaboration with the cancer survivors' oncologists. These procedures are similar to that of URCC 13070, which enrolled caregivers of older patients with advanced cancer
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
United States45 sites, 44 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Valerie Ferguson
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Valerie Ferguson
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Daisy Boehm
- Recruiting
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
Site Public Contact, CancerCare@ChesapeakeRegional.com
Antonio J. Ruiz
- Recruiting
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Karen M. Mustian
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, hemoncctrials@geisinger.edu
Nadia N. Ramdin
- Suspended
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Brian L. Burnette
- Recruiting
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Site Public Contact, 808-524-6115, i.webster@hawaiicancercare.com
Valerie Ferguson
- Recruiting
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
Site Public Contact, 808-522-4333
Valerie Ferguson
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Site Public Contact, 808-983-6090
Valerie Ferguson
- Recruiting
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Site Public Contact, 808-433-6336
Jeffrey L. Berenberg
- Recruiting
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
Site Public Contact, 336-718-8335, asmarrs@novanthealth.org
Judith O. Hopkins
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Regina A. Jacob
- Recruiting
South Central Medical and Resource Center
Lindsay, Oklahoma, 73052
Site Public Contact, 405-756-1414
Zsolt Nagykaldi
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Monticello Cancer Center
Monticello, Minnesota, 55362
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
Site Public Contact, 336-718-8335, asmarrs@novanthealth.org
Judith O. Hopkins
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Highland Hospital
Rochester, New York, 14620
Site Public Contact, 585-341-8113
Karen M. Mustian
- Recruiting
Pluta Cancer Center
Rochester, New York, 14623
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Karen M. Mustian
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Karen M. Mustian
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Community Medical Center
Scranton, Pennsylvania, 18510
Site Public Contact, 570-703-4768, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Recruiting
Novant Health Cancer Institute - Statesville
Stateville, North Carolina, 28625
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
Lakeview Hospital
Stillwater, Minnesota, 55082
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401
Site Public Contact, 800-338-2948
Augusto C. Ochoa
- Recruiting
Wilmot Cancer Institute at Webster
Webster, New York, 14580
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Karen M. Mustian
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Nadia N. Ramdin
- Recruiting
Rice Memorial Hospital
Willmar, Minnesota, 56201
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
- Recruiting
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Site Public Contact, 336-718-8335, pjordan@novanthealth.org
Judith O. Hopkins
- Recruiting
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Sarah E. Jax
About this study
Official title: Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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:
- 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:
- 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.
- Conditions
- Lymphoma, Malignant Solid Neoplasm
- Being tested
- Best Practice, Comprehensive Geriatric Assessment, Educational Intervention, Exercise Intervention, Questionnaire Administration
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual follow-up survivorship care
Comprehensive Geriatric AssessmentOther
Complete geriatric assessment
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Participate in survivorship health education sessions
Participate in SHE-EXCAP program
Questionnaire AdministrationOther
Ancillary studies
Tailored InterventionProcedure or surgery
Participate in GEM consultation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice; Other: Questionnaire Administration |
| 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. Receives: Other: Comprehensive Geriatric Assessment; Other: Educational Intervention; Other: Exercise Intervention; Other: Questionnaire Administration; Procedure: Tailored Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months
Secondary outcomes (1)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start21 Mar 2023
- Primary completion17 May 2027 (estimated)
- Study completion17 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Supriya Mohile, University of Rochester
- Investigators
- Supriya G Mohile, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006482
- Sponsor's protocol ID
- URCC-19178
- Other IDs
- NCI-2021-01760, URCC-19178, URCC-19178, URCC-19178, R01CA249467, UG1CA189961
- Acronym
- GEM-S
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35292232
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study
- ClinicalTrials.gov ID
- NCT05006482
- Acronym / sponsor ID
- GEM-S / URCC-19178
- Conditions
- Lymphoma, Malignant Solid Neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 Sep 2027 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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:
- 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:
- 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.
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 (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationSurvivors 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 | Other: Comprehensive Geriatric Assessment, Other: Educational Intervention, Other: Exercise Intervention, Other: Questionnaire Administration, Procedure: Tailored InterventionSurvivors 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual follow-up survivorship care | Other | Arm I (usual care) |
| Comprehensive Geriatric AssessmentComplete geriatric assessment | Other | Arm II (GEMS intervention) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalParticipate in survivorship health education sessions | Other | Arm II (GEMS intervention) |
| Exercise InterventionParticipate in SHE-EXCAP program | Other | Arm II (GEMS intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual care), Arm II (GEMS intervention) |
| Tailored InterventionParticipate in GEM consultation | Procedure or surgery | Arm II (GEMS intervention) |
Primary outcome
Patient-reported physical function
Time frame: Up to 6 months
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).
1 secondary outcome
Patient-reported cognitive function
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 35292232Yilmaz 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.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Supriya G Mohile principal investigator
University of Rochester NCORP Research Base
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Best Practice, Comprehensive Geriatric Assessment and Educational Intervention in people with Lymphoma and Malignant Solid Neoplasm, run by University of Rochester at 45 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 15 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported physical function (time frame: Up to 6 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 NCT05006482, which also lists 1 linked publication.
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 13 Jan 2026.