Clinical trial NCT05006482: Geriatric Evaluation and Management with Survivorship Health Education (GEMS) for Older Survivors of Cancer
Official title: Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Solid Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-16
Enrollment: 960
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) 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. GEMS 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 GEMS 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:

I. To compare the efficacy of GEMS to usual care for improving patient-reported physical function (Functional Assessment of Cancer Therapy-Fatigue Physical Well-Being Subscale \[FACIT-PWB\]) in older cancer survivors at 6 months.

SECONDARY OBJECTIVE:

I. To compare the efficacy of GEMS to usual care for improving patient-reported cognitive function (FACT-cognitive function \[Cog\]) in older cancer survivors at 6 months.

OUTLINE: Practice sites are randomized to 1 of 2 arms. Participants are assigned to arms based on practice cluster.

ARM I: Patients receive routine survivorship follow-up care at their doctor's office for 5 visits over 12 months. Caregivers will be followed for 3 visits over 6 months.

ARM II: Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks. Patients also participate in Exercise for Cancer Patients (EXCAP) program, which includes daily walking and resistance exercises.

Eligibility criteria: Inclusion Criteria:

* CANCER SURVIVORS: 65 years of age or older
* CANCER SURVIVORS: Have completed or will have completed curative-intent adjuvant chemotherapy for any solid tumor malignancy in last 6 months. Run-in study procedures can occur during the last 4 weeks of adjuvant chemotherapy but must be completed no later than 6 months after the completion of adjuvant chemotherapy. Cancer survivors who will receive other curative-intent treatments (e.g., hormonal treatment, monoclonal antibodies, radiation) other than surgery are eligible
* 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 when necessary
* 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 read 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 University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base
* CAREGIVERS: 18 years of age 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 read 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

Exclusion Criteria:

* CANCER SURVIVORS: Have surgery planned within six months of informed consent. Cancer survivors who previously had surgery are eligible
* 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.

Primary outcomes:
measure: Patient-reported physical function as assessed by the Functional Assessment of Cancer Therapy Physical Well-Being Subscale (FACIT PWB) in cancer survivors.
timeFrame: 6 months
Secondary outcomes:
measure: Patient-reported cognitive function as assessed by Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).
timeFrame: 6 months
Other outcomes:
Locations:
city: Vallejo
country: United States
facility: Kaiser Permanente NCORP (KAISER)
state: California
city: Newark
country: United States
facility: Delaware/Christiana Care NCORP (CHRISTIANA)
state: Delaware
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Minority Underserved NCORP
state: Hawaii
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester NCORP Research Base
state: New York
city: Winston-Salem
country: United States
facility: Novant Health Cancer Institute - Kernersville
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Consortium (SCOR)
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Cancer Institute NCORP (GEISINGER)
state: Pennsylvania
city: Green Bay
country: United States
facility: Cancer Research of Wisconsin and Northern Michigan Consortium
state: Wisconsin
city: Marshfield
country: United States
facility: Wisconsin NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Supriya G Mohile
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.