THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on geriatric oncology. These studies highlight psychological interventions, managing cancer symptoms, the surgical process, fall prevention, and making treatment decisions; as well as platelet recovery in hematologic malignancies and endocrine therapy in breast cancer. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
INTERVENTIONAL
Study Title: Managing Anxiety From Cancer: A Pilot Randomized Controlled Trial of a Psychological Intervention for Anxiety in Older Adults With Cancer and Their Caregivers
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: Weill Medical College of Cornell University, National Institute on Aging, American Federation for Aging Research
Purpose: To examine the preliminary efficacy of a telephone-administered cognitive behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver
Primary Outcome Measures: Anxiety subscale of the Hospital Anxiety and Depression Scale; Hamilton Anxiety Rating Scale [time frame: baseline (1–2 weeks after enrollment) and follow-up (7–9 weeks after baseline)]
Principal Investigator: Kelly Trevino, PhD, Weill Cornell Medicine; contact Chrystal Marte, BA, (646) 962-6179, chm2075@ med.cornell.edu
ClinicalTrials.gov Identifier: NCT03168971
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Study Title: Promoting Cancer Symptom Management in Older Adults
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: University of Central Florida, University of South Florida, Orlando Health Inc.
Purpose: To estimate the effect size of a technology-based intervention for older adults with cancer for nausea and vomiting
Primary Outcome Measures: Symptom severity change, cognitive representation change, and health-related quality of life change over time [time frame: weeks 1, 4, 7, 10]; self-management behaviors over time, resource use over time [time frame: weeks 4, 7, 10]
Principal Investigator: Victoria Loerzel, PhD, University of Central Florida; (407) 823-0762, victoria.loerzel@ucf.edu
ClinicalTrials.gov Identifier: NCT03143829
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Study Title: Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: Massachusetts General Hospital, National Comprehensive Cancer Network
Purpose: To addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection in pancreatic, esophageal, and gastric cancers
Primary Outcome Measures: Hospital length of stay [time frame: 2 years]
Principal Investigator: Ryan Nipp, MD, Massachusetts General Hospital; (617) 724-4000
ClinicalTrials.gov Identifier: NCT02810652
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Study Title: A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center
Purpose: To evaluate a decision aid to help women aged 70 and older decide on treatment for breast cancer
Primary Outcome Measures: Change in decisional conflict scale at 1 week [time frame: baseline, 1 week]
Principal Investigator: Mara Schonberg, MD, MPH, Beth Israel Deaconess Medical Center; (617) 754-1414
ClinicalTrials.gov Identifier: NCT02823262
PHASE I
Study Title: Adaptation of the Stepping On Fall Prevention Program for Older Adults Receiving Cancer Therapy
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To adapt the effective group education–based fall-prevention intervention Stepping On, tailored to cancer patients
Primary Outcome Measures: Percent of participants who completed the 7 educational sessions [time frame: completion of all participants in the Pilot Wave groups (approximately 85 weeks)]
Principal Investigator: Tanya Wildes, MD, MSCI, Washington University School of Medicine; (314) 454-8681, twildes@wustl.edu
ClinicalTrials.gov Identifier: NCT02737839
PHASE II
Study Title: A Single-Arm, Phase II Study of Eltrombopag to Enhance Platelet Count Recovery in Elderly Patients With Acute Myeloid Leukemia Undergoing Remission Induction Therapy
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute
Purpose: To evaluate how well eltrombopag olamine works in improving the recovery of platelet counts in older patients with acute myeloid leukemia undergoing induction chemotherapy
Primary Outcome Measures: Patients with a median platelet count ≥ 50,000/mL [time frame: day 24 of treatment]
Principal Investigator: Sudipto Mukherjee, MD, PhD, MPH, Case Comprehensive Cancer Center; (216) 445-9353, sekerem@ccf.org
ClinicalTrials.gov Identifier: NCT02071901
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Study Title: Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor–Positive Operable Breast Cancer and a Low Recurrence Score
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To evaluate whether endocrine therapy alone provides adequate local/systemic control of breast cancer in women 70 or older with estrogen receptor–positive breast cancer and low Ki67 scores
Primary Outcome Measures: Response rate [time frame: 6 months]
Principal Investigator: Rebecca L. Aft, MD, PhD, Washington University School of Medicine; (314) 747-0063, aftr@wustl.edu
ClinicalTrials.gov Identifier: NCT02476786
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
