Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 668
- 试验地点
- 88
- 主要终点
- Patient-reported physical function
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 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.
干预措施: Best Practice (Other)
Arm 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.
干预措施: Questionnaire Administration (Other)
Arm 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.
干预措施: Comprehensive Geriatric Assessment (Other)
Arm 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.
干预措施: Educational Intervention (Other)
Arm 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.
干预措施: Exercise Intervention (Other)
Arm 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.
干预措施: Questionnaire Administration (Other)
Arm 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.
干预措施: Tailored Intervention (Procedure)
结局指标
主要结局
Patient-reported physical function
时间窗: Up to 6 months
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).
次要结局
- Patient-reported cognitive function(Up to 6 months)
研究者
Supriya Mohile
URCC Study Chair
University of Rochester