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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03060096
Other study ID # IRB00047561
Secondary ID 1R21CA1982375R21
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2018
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.


Description:

Noting the need for evidence-based cancer survivorship care, the American Society of Clinical Oncology (ASCO) published guidelines for screening, assessment, and care of psychosocial distress (anxiety, depression) in adults with cancer. These guidelines recommend screening all adults with cancer for distress and treating those with moderate or severe symptoms using a stepped-care approach tailored to distress severity. While these guidelines apply to survivors with all cancer types across the cancer treatment and survivorship continuum, we have chosen to focus on survivors with non-metastatic breast, colorectal, prostate, uterine, and cervical cancers , as well as those with any stage lymphoma (Hodgkin's or non-Hodgkin's). Further, we have focused on the post-treatment survivorship period 6 months-5 years post-treatment because distress may be more likely to be assessed and addressed after treatment completion. A significant minority of post-treatment survivors is at risk for anxiety and depression symptoms during the five years following the end of treatment and accessible interventions are needed to treat them. The purpose of this study is to test a method of implementing this stepped-care approach in community oncology practices caring for cancer survivors, using self-directed and stepped-care telehealth approaches based on cognitive-behavioral theory. Our approach is based on a previous trial of telephone-based cognitive behavioral therapy for rural older adults with Generalized Anxiety Disorder (NIMH 1R01MH083664: The Tranquil Moments Study; PI: Brenes), which has demonstrated high acceptability and efficacy for reducing anxiety, worry, and depressive symptoms in a rural geriatric population. This protocol adapts the methods of the previous trial to bring psychosocial care to underserved cancer survivors, many of whom have minimal or no access to mental health providers. Cancer survivors will be recruited through multiple NCI Community Oncology Research Program (NCORP) sites through the NCI-funded Wake Forest NCORP Research Base (WF NCORP RB). We will obtain data on feasibility, outcome variability, and efficacy for designing a subsequent fully powered randomized controlled trial (RCT) assessing the effects of the intervention on distress in cancer survivors. In the planned larger study, we anticipate that this intervention will: (a) reduce treatment barriers for post-treatment cancer survivors; (b) enhance availability of psychosocial treatment (through use of telephone sessions and a workbook); and (c) result in reductions in anxiety and depressive symptoms in cancer survivors.


Other known NCT identifiers
  • NCT03190291

Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 31, 2023
Est. primary completion date July 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - Score =10 on the GAD-7 and/or a score =8 on the PHQ-9, indicating clinically significant anxiety or depressive symptoms, respectively. - Past history of treated Stage I, II, or III (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (to include uterine and cervical) cancers and non-Hodgkin's lymphoma. - 6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer. Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on maintenance or hormonal therapies. - Participant resides in California, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, Tennessee, or Wisconsin - Study-trained therapist in the state where the participant resides. - Must be able to speak and understand English. - Must have access to a telephone Exclusion Criteria: - Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days prior to randomization]. - Self-reported active alcohol or substance abuse within the last 30 days. - Past history of prostate cancer or non-Hodgkin's lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy). - Diagnosis of a second malignancy (except for non-melanoma skin cancers) after a previous diagnosis of breast, colorectal, gynecologic cancers and non-Hodgkin's lymphoma - Progressive cancer (must be considered no evidence of disease or stable) - Self -reported history of a diagnosis of dementia from a healthcare provider. - Self -reported psychotic symptoms in the last 30 days prior to randomization - Active suicidal ideation (currently reported suicidal plan and intent). - Any change in psychotropic medications within the last 30 days. - Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff) - Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study.

Study Design


Intervention

Other:
Severe Anxiety/depression: High Intensity Stepped Care
The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.
Moderate Anxiety/depression: Low Intensity Stepped care
The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.
Enhanced Usual Care Control
Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment", self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study.

Locations

Country Name City State
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Augusta University Medical Center Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Cox Cancer Center Branson Branson Missouri
United States Wellmont Bristol Regional Medical Center Bristol Tennessee
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States Fairview Ridges Hospital Burnsville Minnesota
United States Cambridge Medical Center Cambridge Minnesota
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Centralia Oncology Clinic Centralia Illinois
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Mercy Hospital Coon Rapids Minnesota
United States Carle on Vermilion Danville Illinois
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Illinois CancerCare-Dixon Dixon Illinois
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States McLeod Regional Medical Center Florence South Carolina
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Tidelands Georgetown Memorial Hospital Georgetown South Carolina
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Self Regional Healthcare Greenwood South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States HaysMed University of Kansas Health System Hays Kansas
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Capital Region Southwest Campus Jefferson City Missouri
United States Wellmont Medical Associates Oncology and Hematology-Johnson City Johnson City Tennessee
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Truman Medical Centers Kansas City Missouri
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Regional Cancer Center at Indian Path Community Hospital Kingsport Tennessee
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Lawrence Memorial Hospital Lawrence Kansas
United States Illinois CancerCare-Macomb Macomb Illinois
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Sovah Health Martinsville Martinsville Virginia
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Aspirus Medford Hospital Medford Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Kaiser Permanente-Modesto Modesto California
United States Monticello Cancer Center Monticello Minnesota
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Southwest VA Regional Cancer Center Norton Virginia
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-South Sacramento Sacramento California
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Low Country Cancer Care Associates PC Savannah Georgia
United States Summit Cancer Care-Candler Savannah Georgia
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States VCU Community Memorial Health Center South Hill Virginia
United States Spartanburg Medical Center Spartanburg South Carolina
United States Spartanburg Medical Center - Mary Black Campus Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States Mercy Hospital Washington Washington Missouri
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Rice Memorial Hospital Willmar Minnesota
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Rush-Copley Healthcare Center Yorkville Illinois

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of Study Intervention Measured by Retention Study retention will be estimated by the number of participants who complete the Week 7 and 13 visits Randomization through completion of study at week 13
Primary Feasibility of Study Intervention Measured by Adherence to Intervention Intervention adherence will be estimated as the mean proportion of therapy (high-intensity intervention) or check-in (low-intensity intervention) sessions each participant completes. Randomization through completion of study at week 13
Primary Feasibility of Study Intervention Measured by Recruitment Rate Recruitment rate will be determined by the number of eligible participants who met all eligibility criteria and percent who agreed to participate. Screening through end of study at week 13
Primary Feasibility of Study Intervention Measured by Accrual Rate The accrual rate is determined by dividing the overall number of participants recruited in each arm by the total span of 38 months between the start of the first screening for enrollment and the time the study closed to accrual. Start of study screening time to end of study accrual
Secondary Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks The Generalized Anxiety Disorder (GAD) -7 is a self-report measure of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of Generalized Anxiety Disorder (GAD). Longitudinal changes in the GAD-7 will be measured in participants to evaluate the effectiveness of the intervention in reducing anxiety. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. The first 7 questions are summed to create a total score ranging from 0 to 21. Higher scores reflect greater anxiety severity. Scores above 10 are considered to be in the clinical range. GAD-7 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe anxiety, respectively. Screening or baseline (if >30 days since screening), Week 13
Secondary Longitudinal Changes in the Patient Health Questionnaire (PHQ-9) Score for Depression From Baseline to 13 Weeks The PHQ-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder where participants rate how often they experienced 9 symptoms over past 2 weeks. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. Longitudinal changes in the PHQ-9 will be measured in participants to evaluate the effectiveness of the intervention in reducing depression. The possible range is 0-27. A larger score represents more severe depression level. Screening or baseline (if >30 days since screening), Week 13
Secondary Number of Participants With Moderate of Severe Depression (PHQ-9) or Anxiety (GAD-7) at 13 Weeks A combined variable will be created that indicates if a participant had moderate/severe depression or anxiety at mid- or post-intervention. This is defined as either PHQ-9 or GAD-7 greater than or equal to 15. Week 13
Secondary Longitudinal Changes in the Insomnia Severity Index (ISI) From Baseline to 13 Weeks. Measure Description: The Insomnia Severity Index (ISI) is 7-item self-report measure of type and severity of insomnia symptoms, including problems with sleep onset, sleep maintenance, or early morning awakening; satisfaction with current sleep pattern; interference with daily functioning; noticing impairment attributed to sleep problems; and level of concern or distress caused by the sleep problem. Each of the seven items is scored on a 5-point scale, ranging from 0 (lowest) to 4 (highest). The sum of the scores for all seven items yields a total score, which falls within a range of 0 to 28. A higher score indicates a greater level of sleep impairment. Baseline (Week 0), Week 13
Secondary Longitudinal Changes in the PROMIS Fatigue Scale From Baseline to 13 Weeks The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a is a measure of the experience of fatigue and the impact of fatigue on activities across multiple domains. There are eight items rated on a scale of 1(never) to 5 (always) based on how often fatigue was experienced over the last 7 days. The sum of these eight items ranges from a minimum of 8 to a maximum of 40, with higher scores representing more fatigue. This total score is then converted into a t-score based on the PROMIS 8a adult conversion table. The smallest t score is 33.1 and the largest t score is 77.8. A higher t score indicates greater fatigue. Baseline (Week 0), Week 13
Secondary Longitudinal Changes in the Fear of Recurrence Inventory Severity Subscale From Baseline to 13 Weeks The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of cancer recurrence. Range is 0 to 36 with higher values representing higher fear of recurrence. Baseline (Week 0), Week 13
Secondary Longitudinal Changes in the Health Status Questionnaire (SF-36) From Baseline to 13 Weeks The Health Status Questionnaire (SF-36) functions as a self-reporting tool designed to evaluate an individual's quality of life. It consists of 36 items and is organized into eight subscales. Each subscale score is then translated into a linear scale that spans from 0 to 100. A higher score means enhanced quality of life. Additionally, the questionnaire incorporates two domains as mental health component and physical health component. These domains are the results of linear aggregation from the 8 subscales and transforming into T score metric. In these metrics, the t score has a mean of 50 and a standard deviation of 10 based on the characteristics of U.S. general population for both mental and physical health sub scores. A higher T-score corresponds to a higher quality of life for that subscale. Baseline (Week 0), Week 13
Secondary Longitudinal Changes in the Impact of Events Scale-Revised (IES-R) From Baseline to 13 Weeks The Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure of cancer related distress. The IES-R assesses the frequency with which respondents experience intrusive thoughts, avoidant behaviors, and autonomic arousal specific to one's thoughts and feelings about cancer over the past week. Each item is rated on a 5-point scale ranging from 0("not at all") to 4("extremely"). The higher grade indicates greater stress. IES- R total score is the sum of the means of the three subscale scores. IES- R total score ranges from 0 to 12. The higher scores indicate higher cancer distress. Baseline (Week 0), Week 13
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