Clinical Research Directory

Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant

A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)

Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors

This protocol is a retrospective study using observational data to conduct a target trial emulation to examine the association of exercise on cancer specific endpoints and other clinical outcomes in cancer survivors.

Dance Study for Post-surgical Pain in Breast Cancer Survivors

The purpose of this study is to examine how a 12-week, virtual dance program may improve pain and quality of life in participants with persistent post-surgical pain, or PPSP, following mastectomy or lumpectomy.

A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

More than 80% of childhood cancer survivors develop serious or life-threatening late effects after cancer therapy, but \<20% receive recommended survivorship care offered at cancer center survivorship clinics. In a shared care model, the investigators propose to investigate an innovative multi-level intervention consisting of: 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record patient portal, 3) a structured interactive phone communication between the cancer center and the primary care clinic, and 4) an in-person visit with the primary care clinic for survivorship care with the goal of achieving high rates of adherence to recommended surveillance for late effects, as well as improving patient and physician knowledge and self-efficacy. If this scalable intervention demonstrates patient completion of recommended care comparable to cancer center survivorship clinics, this innovative study has the enormous potential to deliver recommended care to a larger proportion of childhood cancer survivors and reduce survivorship care disparities, while engaging p to integrate survivorship care as part of overall, lifelong health maintenance.

Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience

This is a homogeneous, single institution, observational, non-interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast conserving surgery, at a total dose of 40 Gy/ 15 fr (5 fr/ week, 3 consecutive weeks). In addition to the regular follow up, the patients will respond to the quality-of-life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at the first visit, at the end of radiotherapy and at the subsequent follow-up visits from 6 months up to 5 and a half years, to evaluate the quality of life during and after the treatment. The study also has a retrospective arm of approximately 3300 patients (number of patients and characteristics of disease expanded with the amendment presented to the Lombardia 1 Ethics Committee in May 22/2024), treated from January 2009, for whom disease control and toxicity will be evaluated.

Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.

A Study of Cognitive Health in Survivors of Prostate Cancer

The purpose of this study is to collect information that may help the researchers understand the relationship between prostate cancer survivors' experiences of cancer-related cognitive dysfunction (CRCD) and their other conditions (co-morbid factors), including anxiety, depression, and insomnia. The researchers will also find out how additional things may contribute to CRCD, including social factors, the characteristics of participants' prostate cancer, and the type of cancer treatment or other medications they received.

Food Is Medicine In Survivorship (Foodiis-AYA): Examining The Feasibility And Acceptability Of A Remotely-Delivered Meal Kit And Culinary Medicine Program For Survivors Of Adolescent/Young Adult (AYA) Cancer

To study the feasibility of a new nutritional intervention (Food is Medicine in Survivorship - Adolescents / Young Adults \[FoodiiSAYA\]) for patients 18-25 years old who have completed cancer treatment.

Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors

The purpose of this study is to evaluate different combinations of cancer education sessions, counseling sessions, and peer support meetings developed for Chinese cancer patients and survivors. The researchers will look at whether the combinations are practical and effective, and how they impact participants' quality of life.

Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.

Prospective G7 Dual Mobility Total Hip PMCF

This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.

Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning. Primary Objective To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL. Secondary Objectives To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL. Exploratory Objectives To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.

Linking In With Advice and Supports for Men Impacted by Metastatic Cancer

To evaluate the feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary malignancies.

Cognitive Rehabilitation for Survivors of Childhood Medulloblastoma Using Real Time Hemodynamic Neurofeedback

This study will evaluate a new way to help childhood medulloblastoma survivors improve their thinking and memory skills. Many survivors experience long term challenges with attention and working memory because of the tumor and its treatments. The study uses real time neuroimaging technologies such as real time functional magnetic resonance imaging (rt-fMRI) and real time functional near infrared spectroscopy (rt-fNIRS) make it possible to monitor and display a participant's brain activity as it occurs. Neurofeedback uses this activity to provide individuals with immediate visual information about how specific brain regions are functioning, potentially enabling them to learn strategies to modulate or improve brain activity linked to thinking skills. Participants are randomly assigned to one of two groups. One group receives feedback from a brain area involved in working memory, and the other receives feedback from a different brain region as a comparison. Over three visits, participants complete brain scans, neurofeedback sessions, and thinking and memory tests. The main goal is to see if this type of brain training is practical, safe, and comfortable for survivors. The study also looks at whether the training may help improve brain activity and working memory performance. Primary Objective(s): • To evaluate the feasibility of real time Hemo-NFB neurofeedback training in medulloblastoma survivors. Secondary Objective(s): • To estimate the initial efficacy of Hemo-NFB neurofeedback to up-regulate the activity of the dorsolateral prefrontal cortex (DLPFC) and improve WM performance.

Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children

This trial examines the usefulness of two educational programs for parents with late-stage cancer who have a 5 - 17 year old child. The programs are designed to enhance the quality of the parent-child relationship and add to the parent's confidence in managing the impact of their cancer on their child. Educational programs may reduce anxiety and depression and improve the well-being and quality of life of parents with advanced cancers and their children. Recruitment occurs nationally via referral to the Fred Hutch/University of Washington Cancer Consortium team.

Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure \[PROM\] of HNC-related body image distress \[BID\]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators).

Patient- Generated Health Data to Predict Childhood Cancer Survivorship Outcomes

Some childhood cancer survivors have health problems as the result of previous cancer treatment. This study is being done to determine if we can better predict the risk a childhood cancer survivor might have for developing future health issues. The goal of this study is to enable regular monitoring of patient-generated health data (PGHD), including symptoms, physical activity, energy expenditure, sleep behavior and heart rate variability, and utilize these data in predicting survivor-specific risk of late effects to improve survivorship care and outcomes.

LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training

In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).

Patient-Reported Outcome Version of the Common Criteria for Adverse Events

Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the occurrence of chronic health conditions, but also impact quality of life and survival. The National Cancer Institute (NCI) has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic adverse events (AEs) for adult-onset cancer patients who are receiving cancer therapies. However, content-appropriate and clinically validated symptom assessment tools for adult survivors of childhood cancer are not available. Primary Object 1: Establish content validity for the PRO-CTCAE-SCC Primary Objective 1A: Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer Primary Objective 1B: Create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items Primary Objective 2: Validate the PRO-CTCAE-SCC using psychometric methods and objective clinical parameters Primary Objective 2A: Test dimensionality for the PRO-CTCAE-SCC Primary Objective 2B: Test clinical validity for the PRO-CTCAE-SCC Primary Objective 2C: Test responsiveness to change for the PRO-CTCAE-SCC Secondary Objective 1: Increase clinical usefulness of the PRO-CTCAE-SCC Secondary Objective 2: Establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making

A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors

The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.