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治験 NCT05006482 (GEM-S)(対象:リンパ腫、悪性固形腫瘍)は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます!「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05006482 (GEM-S) は リンパ腫、悪性固形腫瘍 に関する 支持療法 の研究で、第III相・第三段階 介入研究 臨床試験 です。現在は 募集中 で、2023年7月18日 から開始しています。668 名の参加者 の募集が計画されています。この治験は ロチェスター大学 によって主催され、2027年5月17日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月3日 です。
概要
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.
詳細説明
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.

公式タイトル

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

疾患/病気
リンパ腫悪性固形腫瘍
刊行物
この臨床試験について発表された科学記事と研究論文:
その他の研究識別子
NCT番号
開始日
2023-07-18
最終更新日
2025-12-03
終了予定日
2027-05-17
目標参加者数
668
試験の種類
介入研究
治験の相・段階
第III相・第三段階
状況
募集中
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
なし(非盲検)
群(アーム)/介入
参加グループ/群介入/治療法
実薬対照薬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.
最良の実践
Receive usual follow-up survivorship care
アンケート管理
Ancillary studies
実験的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.
包括的高齢者評価
Complete geriatric assessment
教育的介入
Participate in survivorship health education sessions
運動介入
Participate in SHE-EXCAP program
アンケート管理
Ancillary studies
Tailored Intervention
Participate in GEM consultation
主要評価項目
評価指標指標の説明時間枠
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
副次評価項目
評価指標指標の説明時間枠
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
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • 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
責任者
Supriya Mohile, 研究責任者, URCC Study Chair, University of Rochester
連絡先情報がありません。
45 1カ国の場所

Alabama

Lewis and Faye Manderson Cancer Center, Tuscaloosa, Alabama, 35401, United States
Site Public Contact, 連絡先, 800-338-2948
Augusto C. Ochoa, 研究責任者
募集中

California

Kaiser Permanente-Fremont, Fremont, California, 94538, United States
Site Public Contact, 連絡先, 877-642-4691, [email protected]
Samantha A. Seaward, 研究責任者
募集中
Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States
Site Public Contact, 連絡先, 877-642-4691, [email protected]
Samantha A. Seaward, 研究責任者
募集中

Delaware

Helen F Graham Cancer Center, Newark, Delaware, 19713, United States
Site Public Contact, 連絡先, 302-623-4450, [email protected]
Gregory A. Masters, 研究責任者
募集中
Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States
Site Public Contact, 連絡先, 302-623-4450, [email protected]
Gregory A. Masters, 研究責任者
募集中

Hawaii

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

Illinois

OSF Saint Anthony's Health Center, Alton, Illinois, 62002, United States
Site Public Contact, 連絡先, 618-463-5623
Jay W. Carlson, 研究責任者
募集中

Minnesota

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

Missouri

Lake Regional Hospital, Osage Beach, Missouri, 65065, United States
Site Public Contact, 連絡先, 573-302-2768, [email protected]
Jay W. Carlson, 研究責任者
募集中

New York

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

North Carolina

Novant Health Breast Surgery - Greensboro, Greensboro, North Carolina, 27403, United States
Site Public Contact, 連絡先, 336-718-8335, [email protected]
Judith O. Hopkins, 研究責任者
募集中
Novant Health Cancer Institute - Kernersville, Kernersville, North Carolina, 27284, United States
Site Public Contact, 連絡先, 336-718-8335, [email protected]
Judith O. Hopkins, 研究責任者
募集中
Novant Health Cancer Institute - Mount Airy, Mount Airy, North Carolina, 27030, United States
Site Public Contact, 連絡先, 336-718-8335, [email protected]
Judith O. Hopkins, 研究責任者
募集中
Novant Health Cancer Institute - Statesville, Stateville, North Carolina, 28625, United States
Site Public Contact, 連絡先, 336-718-8335, [email protected]
Judith O. Hopkins, 研究責任者
募集中
Novant Health Cancer Institute - Thomasville, Thomasville, North Carolina, 27360, United States
Site Public Contact, 連絡先, 336-718-8335, [email protected]
Judith O. Hopkins, 研究責任者
募集中
Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, 27103, United States
Site Public Contact, 連絡先, 336-718-8335, [email protected]
Judith O. Hopkins, 研究責任者
募集中

Oklahoma

South Central Medical and Resource Center, Lindsay, Oklahoma, 73052, United States
Site Public Contact, 連絡先, 405-756-1414
Zsolt Nagykaldi, 研究責任者
募集中

Pennsylvania

Geisinger Medical Center, Danville, Pennsylvania, 17822, United States
Site Public Contact, 連絡先, 570-271-5251, [email protected]
Nadia N. Ramdin, 研究責任者
募集中
Geisinger Cancer Center Dickson City, Dickson City, Pennsylvania, 18519, United States
Site Public Contact, 連絡先, 877-204-6081, [email protected]
Nadia N. Ramdin, 研究責任者
募集中
Community Medical Center, Scranton, Pennsylvania, 18510, United States
Site Public Contact, 連絡先, 570-703-4768, [email protected]
Nadia N. Ramdin, 研究責任者
募集中
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, 18711, United States
Site Public Contact, 連絡先, 570-271-5251, [email protected]
Nadia N. Ramdin, 研究責任者
募集中

Virginia

Chesapeake Regional Medical Center, Chesapeake, Virginia, 23320, United States
Site Public Contact, 連絡先, [email protected]
Antonio J. Ruiz, 研究責任者
募集中

Wisconsin

ThedaCare Regional Cancer Center, Appleton, Wisconsin, 54911, United States
Site Public Contact, 連絡先, 920-364-3604, [email protected]
Daisy Boehm, 研究責任者
募集中
HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, 54701, United States
一時停止
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States
Site Public Contact, 連絡先, 920-433-8889, [email protected]
Brian L. Burnette, 研究責任者
募集中
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, 54303, United States
Site Public Contact, 連絡先, 920-433-8889, [email protected]
Brian L. Burnette, 研究責任者
募集中
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, 54482, United States
Site Public Contact, 連絡先, 800-782-8581, [email protected]
Adedayo A. Onitilo, 研究責任者
募集中
Marshfield Medical Center - Weston, Weston, Wisconsin, 54476, United States
Site Public Contact, 連絡先, 800-782-8581, [email protected]
Adedayo A. Onitilo, 研究責任者
募集中