RECRUITING

Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study

Quick Facts

Study Start:2023-07-18
Study Completion:2027-05-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05006482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Oncologists/APPs/other clinicians must be licensed to practice
  3. * 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
  4. * 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
  5. * 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
  6. * CANCER SURVIVORS: 65 years or older
  7. * 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.
  8. * Cancer survivors who will receive or are receiving other treatments (e.g., hormonal treatment, monoclonal antibodies, immunotherapy, radiation) are eligible
  9. * 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
  10. * 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
  11. * 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
  12. * 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
  13. * CAREGIVERS: 18 years or older
  14. * 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
  15. * 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
  1. * CANCER SURVIVORS: Have a condition that precludes their ability to participate in informed consent or procedures (e.g., dementia)
  2. * CAREGIVERS: Caregivers unable to understand the informed consent form or study procedures due to cognitive, health, or sensory impairment will be excluded
  3. * 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

Contacts and Locations

Principal Investigator

Supriya G Mohile
PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base

Study Locations (Sites)

Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, 35401
United States
Kaiser Permanente-Fremont
Fremont, California, 94538
United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859
United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
United States
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Lake Regional Hospital
Osage Beach, Missouri, 65065
United States
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
United States
Highland Hospital
Rochester, New York, 14620
United States
Pluta Cancer Center
Rochester, New York, 14623
United States
University of Rochester
Rochester, New York, 14642
United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580
United States
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
United States
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
United States
Novant Health Cancer Institute - Statesville
Stateville, North Carolina, 28625
United States
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
United States
South Central Medical and Resource Center
Lindsay, Oklahoma, 73052
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
United States
Community Medical Center
Scranton, Pennsylvania, 18510
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Supriya G Mohile, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-18
Study Completion Date2027-05-17

Study Record Updates

Study Start Date2023-07-18
Study Completion Date2027-05-17

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoma
  • Malignant Solid Neoplasm