RecruitingPhase 3NCT05006482

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

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


Sponsor

University of Rochester

Enrollment

668 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • 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
  • 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

Exclusion Criteria3

  • 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

Interventions

OTHERBest Practice

Receive usual follow-up survivorship care

OTHERComprehensive Geriatric Assessment

Complete geriatric assessment

OTHEREducational Intervention

Participate in survivorship health education sessions

OTHERExercise Intervention

Participate in SHE-EXCAP program

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURETailored Intervention

Participate in GEM consultation


Locations(45)

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Lake Regional Hospital

Osage Beach, Missouri, United States

Noyes Memorial Hospital/Myers Cancer Center

Dansville, New York, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Highland Hospital

Rochester, New York, United States

Pluta Cancer Center

Rochester, New York, United States

University of Rochester

Rochester, New York, United States

Wilmot Cancer Institute at Webster

Webster, New York, United States

Novant Health Breast Surgery - Greensboro

Greensboro, North Carolina, United States

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina, United States

Novant Health Cancer Institute - Mount Airy

Mount Airy, North Carolina, United States

Novant Health Cancer Institute - Statesville

Stateville, North Carolina, United States

Novant Health Cancer Institute - Thomasville

Thomasville, North Carolina, United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

South Central Medical and Resource Center

Lindsay, Oklahoma, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Cancer Center Dickson City

Dickson City, Pennsylvania, United States

Community Medical Center

Scranton, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Chesapeake Regional Medical Center

Chesapeake, Virginia, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

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