Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer

Malignant Solid Neoplasm Clinical Trial

Official title:

Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006482
• Other study ID #: URCC-19178
• Secondary ID: NCI-2021-01760UR
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Caitlyn Hoffman
• Phone: 585-274-0487
• Email: URCC_19178[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: December 31, 2028
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Solid Neoplasm

Intervention

Other:
• Best Practice
Receive usual follow-up survivorship care
• Comprehensive Geriatric Assessment
Complete geriatric assessment
• Educational Intervention
Participate in survivorship health education sessions
• Exercise Intervention
Participate in EXCAP program
• Questionnaire Administration
Ancillary studies

Procedure:
• Tailored Intervention
Participate in GEM consultation

Locations

Country	Name	City	State
United States	Geisinger Cancer Institute NCORP (GEISINGER)	Danville	Pennsylvania
United States	Cancer Research of Wisconsin and Northern Michigan Consortium	Green Bay	Wisconsin
United States	Hawaii Minority Underserved NCORP	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	Wisconsin NCORP	Marshfield	Wisconsin
United States	Delaware/Christiana Care NCORP (CHRISTIANA)	Newark	Delaware
United States	University of Rochester NCORP Research Base	Rochester	New York
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Kaiser Permanente NCORP (KAISER)	Vallejo	California
United States	Novant Health Cancer Institute - Kernersville	Winston-Salem	North Carolina
United States	Southeast Clinical Oncology Research Consortium (SCOR)	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported physical function as assessed by the Functional Assessment of Cancer Therapy Physical Well-Being Subscale (FACIT PWB) in cancer survivors.	The FACIT-F is a 40-item questionnaire divided into 5 domains: physical well-being (PWB; 7-items), social/family well-being (SWB; 7-items), emotional well-being (EWB; 6-items), functional well-being (FWB; 7-items), and fatigue (13-items). 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).; We will test the efficacy of the GEMS intervention on self-reported physical function at 6 months by calculating the average between-arm difference in change in the FACIT-PWB subscale score from baseline to 6 months. To estimate the intervention effects, we will use an ANCOVA model with an additional random effect term to account for clustering.	6 months
Secondary	Patient-reported cognitive function as assessed by Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).	The FACT-Cog provides an overall score and subdomain scores (perceived cognitive impairment (PCI), perceived abilities, comments from others, impact on quality of life) (37 items each with a 5 point Likert scale response). The secondary aim will be the FACT-Cog Perceived Cognitive Impairment score [PCI] at 6 months. We will apply the same analytical approach as for the primary aim to assess the intervention effect on FACT-Cog PCI and same statistical power considerations apply.	6 months