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Eine Studie entspricht den Filterkriterien
Kartenansicht

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

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05006482 (GEM-S) untersucht Supportivtherapie im Zusammenhang mit Lymphom, Bösartige solide Neoplasie. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 18. Juli 2023. Es ist geplant, 668 Teilnehmer aufzunehmen. Durchgeführt von Universität Rochester wird der Abschluss für 17. Mai 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. Dezember 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

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

Erkrankungen
LymphomBösartige solide Neoplasie
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2023-07-18
Zuletzt aktualisiert
2025-12-03
Studienende (vorauss.)
2027-05-17
Geplante Rekrutierung
668
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives VergleichspräparatArm I (usual care)
Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study.
Best Practice
Receive usual follow-up survivorship care
Fragebogenverwaltung
Ancillary studies
ExperimentellArm II (GEMS intervention)
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.
Umfassende geriatrische Bewertung
Complete geriatric assessment
Bildungsintervention
Participate in survivorship health education sessions
Bewegungsintervention
Participate in SHE-EXCAP program
Fragebogenverwaltung
Ancillary studies
Tailored Intervention
Participate in GEM consultation
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
Up to 6 months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • 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

  • 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
Verantwortliche Partei
Supriya Mohile, Hauptprüfer, URCC Study Chair, University of Rochester
Keine Kontaktdaten vorhanden
45 Studienstandorte in 1 Ländern

Alabama

Lewis and Faye Manderson Cancer Center, Tuscaloosa, Alabama, 35401, United States
Site Public Contact, Kontakt, 800-338-2948
Augusto C. Ochoa, Hauptprüfer
Offene Rekrutierung

California

Kaiser Permanente-Fremont, Fremont, California, 94538, United States
Site Public Contact, Kontakt, 877-642-4691, [email protected]
Samantha A. Seaward, Hauptprüfer
Offene Rekrutierung
Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States
Site Public Contact, Kontakt, 877-642-4691, [email protected]
Samantha A. Seaward, Hauptprüfer
Offene Rekrutierung

Delaware

Helen F Graham Cancer Center, Newark, Delaware, 19713, United States
Site Public Contact, Kontakt, 302-623-4450, [email protected]
Gregory A. Masters, Hauptprüfer
Offene Rekrutierung
Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States
Site Public Contact, Kontakt, 302-623-4450, [email protected]
Gregory A. Masters, Hauptprüfer
Offene Rekrutierung

Hawaii

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, 96813, United States
Site Public Contact, Kontakt, 808-524-6115, [email protected]
Valerie Ferguson, Hauptprüfer
Offene Rekrutierung
Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States
Site Public Contact, Kontakt, 808-522-4333
Valerie Ferguson, Hauptprüfer
Offene Rekrutierung
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States
Site Public Contact, Kontakt, 808-983-6090
Valerie Ferguson, Hauptprüfer
Offene Rekrutierung
Tripler Army Medical Center, Honolulu, Hawaii, 96859, United States
Site Public Contact, Kontakt, 808-433-6336
Jeffrey L. Berenberg, Hauptprüfer
Offene Rekrutierung
Hawaii Cancer Care - Westridge, ‘Aiea, Hawaii, 96701, United States
Site Public Contact, Kontakt, 808-539-2273, [email protected]
Valerie Ferguson, Hauptprüfer
Offene Rekrutierung
Pali Momi Medical Center, ‘Aiea, Hawaii, 96701, United States
Site Public Contact, Kontakt, 808-486-6000
Valerie Ferguson, Hauptprüfer
Offene Rekrutierung

Illinois

OSF Saint Anthony's Health Center, Alton, Illinois, 62002, United States
Site Public Contact, Kontakt, 618-463-5623
Jay W. Carlson, Hauptprüfer
Offene Rekrutierung

Minnesota

Fairview Southdale Hospital, Edina, Minnesota, 55435, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Hennepin County Medical Center, Minneapolis, Minnesota, 55415, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Monticello Cancer Center, Monticello, Minnesota, 55362, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Regions Hospital, Saint Paul, Minnesota, 55101, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Lakeview Hospital, Stillwater, Minnesota, 55082, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Rice Memorial Hospital, Willmar, Minnesota, 56201, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, 55125, United States
Site Public Contact, Kontakt, 952-993-1517, [email protected]
Sarah E. Jax, Hauptprüfer
Offene Rekrutierung

Missouri

Lake Regional Hospital, Osage Beach, Missouri, 65065, United States
Site Public Contact, Kontakt, 573-302-2768, [email protected]
Jay W. Carlson, Hauptprüfer
Offene Rekrutierung

New York

Noyes Memorial Hospital/Myers Cancer Center, Dansville, New York, 14437, United States
Site Public Contact, Kontakt, [email protected]
Karen M. Mustian, Hauptprüfer
Offene Rekrutierung
Northwell Health/Center for Advanced Medicine, Lake Success, New York, 11042, United States
Site Public Contact, Kontakt, 516-734-8896
Regina A. Jacob, Hauptprüfer
Offene Rekrutierung
Highland Hospital, Rochester, New York, 14620, United States
Site Public Contact, Kontakt, 585-341-8113
Karen M. Mustian, Hauptprüfer
Offene Rekrutierung
Pluta Cancer Center, Rochester, New York, 14623, United States
Site Public Contact, Kontakt, 888-823-5923, [email protected]
Karen M. Mustian, Hauptprüfer
Offene Rekrutierung
University of Rochester, Rochester, New York, 14642, United States
Site Public Contact, Kontakt, 585-275-5830
Karen M. Mustian, Hauptprüfer
Offene Rekrutierung
Wilmot Cancer Institute at Webster, Webster, New York, 14580, United States
Site Public Contact, Kontakt, [email protected]
Karen M. Mustian, Hauptprüfer
Offene Rekrutierung

North Carolina

Novant Health Breast Surgery - Greensboro, Greensboro, North Carolina, 27403, United States
Site Public Contact, Kontakt, 336-718-8335, [email protected]
Judith O. Hopkins, Hauptprüfer
Offene Rekrutierung
Novant Health Cancer Institute - Kernersville, Kernersville, North Carolina, 27284, United States
Site Public Contact, Kontakt, 336-718-8335, [email protected]
Judith O. Hopkins, Hauptprüfer
Offene Rekrutierung
Novant Health Cancer Institute - Mount Airy, Mount Airy, North Carolina, 27030, United States
Site Public Contact, Kontakt, 336-718-8335, [email protected]
Judith O. Hopkins, Hauptprüfer
Offene Rekrutierung
Novant Health Cancer Institute - Statesville, Stateville, North Carolina, 28625, United States
Site Public Contact, Kontakt, 336-718-8335, [email protected]
Judith O. Hopkins, Hauptprüfer
Offene Rekrutierung
Novant Health Cancer Institute - Thomasville, Thomasville, North Carolina, 27360, United States
Site Public Contact, Kontakt, 336-718-8335, [email protected]
Judith O. Hopkins, Hauptprüfer
Offene Rekrutierung
Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, 27103, United States
Site Public Contact, Kontakt, 336-718-8335, [email protected]
Judith O. Hopkins, Hauptprüfer
Offene Rekrutierung

Oklahoma

South Central Medical and Resource Center, Lindsay, Oklahoma, 73052, United States
Site Public Contact, Kontakt, 405-756-1414
Zsolt Nagykaldi, Hauptprüfer
Offene Rekrutierung

Pennsylvania

Geisinger Medical Center, Danville, Pennsylvania, 17822, United States
Site Public Contact, Kontakt, 570-271-5251, [email protected]
Nadia N. Ramdin, Hauptprüfer
Offene Rekrutierung
Geisinger Cancer Center Dickson City, Dickson City, Pennsylvania, 18519, United States
Site Public Contact, Kontakt, 877-204-6081, [email protected]
Nadia N. Ramdin, Hauptprüfer
Offene Rekrutierung
Community Medical Center, Scranton, Pennsylvania, 18510, United States
Site Public Contact, Kontakt, 570-703-4768, [email protected]
Nadia N. Ramdin, Hauptprüfer
Offene Rekrutierung
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, 18711, United States
Site Public Contact, Kontakt, 570-271-5251, [email protected]
Nadia N. Ramdin, Hauptprüfer
Offene Rekrutierung

Virginia

Chesapeake Regional Medical Center, Chesapeake, Virginia, 23320, United States
Site Public Contact, Kontakt, [email protected]
Antonio J. Ruiz, Hauptprüfer
Offene Rekrutierung

Wisconsin

ThedaCare Regional Cancer Center, Appleton, Wisconsin, 54911, United States
Site Public Contact, Kontakt, 920-364-3604, [email protected]
Daisy Boehm, Hauptprüfer
Offene Rekrutierung
HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, 54701, United States
Ausgesetzt
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States
Site Public Contact, Kontakt, 920-433-8889, [email protected]
Brian L. Burnette, Hauptprüfer
Offene Rekrutierung
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, 54303, United States
Site Public Contact, Kontakt, 920-433-8889, [email protected]
Brian L. Burnette, Hauptprüfer
Offene Rekrutierung
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, 54482, United States
Site Public Contact, Kontakt, 800-782-8581, [email protected]
Adedayo A. Onitilo, Hauptprüfer
Offene Rekrutierung
Marshfield Medical Center - Weston, Weston, Wisconsin, 54476, United States
Site Public Contact, Kontakt, 800-782-8581, [email protected]
Adedayo A. Onitilo, Hauptprüfer
Offene Rekrutierung