Clinical Research Directory

Breast Cancer Rehabilitation Needs and Service Uptake

The investigators are attempting to verify the prevalence of cancer rehabilitation needs at our institution in breast cancer patients. The investigators also want to assess 1) self-perceived needs for cancer rehabilitation services, 2) awareness, willingness, and patient health beliefs as determinants for cancer rehabilitation-seeking behaviour, and 3) the modifiable patient factors driving the mismatch between needs and uptake in our population. Patients attending outpatient clinics in our hospital will be approached to answer a questionnaire designed to find out this information. The investigators hope that the results will ultimately inform the design of better triage and referral systems that match patients to services based on their rehabilitation needs. The investigators believe that local survivors of breast cancer have unmet rehabilitation needs and that it is possible to evaluate their readiness to seek access to rehabilitation services as well as identify mismatches between provided and desired services through the administration of a cancer rehabilitation questionnaire (CRQ).

Innovating CBT-I for Cancer Survivors: An Optimization Trial

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study

This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive and physical function among cancer survivors and support persons. This study will involve a 6-month home-based virtually supervised or unsupervised exercise and diet intervention. The names of the study interventions involved in this study are: * Virtually supervised exercise and healthy diet care * Unsupervised exercise and healthy diet care

Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Participants will be randomly assigned to one of three study arms: stepped-care web-based CBT-I (eSTEPCBT-I), standardized web-based CBT-I (eSTANDCBT-I), or care as usual (CAU). The study aims to determine whether a stepped-care approach can improve access to effective insomnia treatment while maintaining clinical effectiveness and cost-effectiveness.

Patient-Initiated Follow-Up for Women After Early Breast Cancer Treatment (LYSA2PIFU)

Women treated for early-stage breast cancer commonly experience ongoing treatment-related symptoms while receiving adjuvant endocrine therapy. The LYSA2PIFU Trial will evaluate the feasibility and acceptability of a nurse-led Patient-Initiated Follow-Up (PIFU) model supported by electronic Patient-Reported Outcomes (ePROs), automated symptom-management resources, educational materials and symptom-triggered nurse consultations.

AYA Cancer Transitions Program

This is a single-arm, minimal-risk, interventional behavioral clinical trial embedding structured transition support for adolescent and young adult (AYA) survivors of pediatric cancer transitioning into adult-focused survivorship care. Aims are to improve AYA transition from pediatric to adult survivorship care and to enhance AYA access to fertility education and care. Patient Participants will: 1. Complete a pre-transition developmental needs assessment 2. Receive up to 2 years of AYA nurse navigation support

Resistance Training and Creatine Supplementation for Head and Neck Cancer

The study will examine a 10-week resistance training program, with or without creatine monohydrate supplementation, in adult survivors of head and neck cancer. Participants will undergo screening and complete study assessments before and after the training period and at a follow-up evaluation. The study will evaluate feasibility, safety, body composition, physical function, cancer-related fatigue, quality of life, and symptom burden in this population.

Improving Radon Education and Awareness in Cancer Patients and Their Extended Community

Clinical appointments are an opportunity to provide cancer survivors (defined as patients and survivors) and people in their communities (e.g. caregivers, family members, friends) with education about radon and radon testing. This is a pilot study to develop and evaluate the impact of a clinic-based intervention that educates cancer survivors and their caregivers/families about radon and radon testing. This study will enroll survivors, caregivers, and interested family members or friends in this intervention because they are important decision-makers with respect to the survivors' cancer care and well-being. This intervention would occur in clinics that treat lung cancer as well as clinics that treat cancers for which radon is being investigated as a contributor to their etiology (e.g. breast, skin melanoma, gastrointestinal).

Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma

This study is evaluating whether a weight-loss medication (PHEN/TOP) combined with healthy lifestyle counseling is safe, well tolerated, and can help reduce obesity in adolescents and young adults who are in remission from ALL, Hodgkin lymphoma, or non-Hodgkin lymphoma. Participants are randomly assigned to receive either PHEN/TOP plus counseling or counseling alone for 24 weeks and are followed for up to 52 weeks.

Increasing Engagement With Digital Behavioral Health

This is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Phase 1 is a formative qualitative study designed to identify survivor-reported needs and preferences for increasing engagement with a mindfulness meditation app. Phase 2 is a pilot intervention study that will examine the feasibility, acceptability, and preliminary engagement outcomes of the Mindful Peer Coach program using participant surveys, app-use data, peer-coach training, coaching sessions, weekly text-message check-ins, and exit interviews with survivors and coaches.

Brief Meaning-making for Young Adult Cancer Survivors

The goal of this feasibility study is to learn if a brief meaning-making wellness intervention based on Viktor Frankl's Existential Psychology works to improve fatigue levels in Young Adult Cancer Survivors (YACS) who have completed primary treatment. The main questions it aims to answer are: * What would be the recruitment and retention rates? * What might the feedback from participants be? * Could there be any effects on fatigue and other related symptoms? Researchers will compare meaning-making to usual care (no intervention) to see if meaning-making works to improve fatigue and other symptoms in YACS. Participants will: * Complete questionnaires (self-reported outcome measures) at baseline, 1-week post-intervention, and at 1-month follow-up. * Attend an in-person, two-session brief meaning-making program

AI-Based Symptom Management for Post-Treatment Breast Cancer Survivors

This pilot randomized controlled trial will test the feasibility and acceptability of an Artificial Intelligence-based Multidimensional Symptom Management (AIMS) intervention for post-treatment breast cancer survivors. Thirty-six participants will be randomly assigned (1:1) to receive either the AIMS intervention or usual care. Outcomes include feasibility (recruitment and retention), adherence, acceptability, symptom burden, psychological distress, quality of life, and safety of the AIMS intervention.

Evaluating the Implementation of a Need-Based Cancer Survivorship Program

The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.

mHealth Intervention for Pain Self Management

This is a feasibility pilot test of a single-arm intervention to evaluate the beta version of an mHealth app-based behavioral intervention prior to scaling for a randomized controlled trial (RCT). This mHealth intervention is designed to enhance self-efficacy and support pain and symptom self-management among post-treatment cancer survivors.

BfedBwell INSPIRE Pilot

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.

Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors

The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for adolescent and young adult cancer survivors compared to a self-guided arm. Participants, diagnosed with cancer between ages 15-39, currently age 18-39, post-treatment at least 6 months, and who have overweight or obesity will be randomized to receive either: 1) a comprehensive mHealth weight management program (intervention) or 2) digital tools + health education + peer support (self-guided) over 12 months. Outcomes will be assessed at 3, 6, and 12 months.

Bridging the Gap in Psychosocial Care for Cancer Survivors

The study aims to assess the feasibility and acceptability of the implementation of a routine digital psychosocial screening combined with a psycho-oncological Navigation Call for cancer survivors after completion of primary treatment with the goal to improve identification of psychosocial needs and facilitate access to supportive care.

Effects of Latin Dancing on Sleep Quality in Hispanic Cancer Survivors

The primary objective is to assess the feasibility, acceptability and explore the impact of a culturally appropriate Latin Dance intervention vs. Usual Care on sleep quality for Hispanic cancer survivors. Secondary objectives are to examine the preliminary efficacy of a culturally appropriate Latin Dance intervention on secondary cancer- and treatment-related side effects (e.g., Quality of Life, distress, insomnia, fatigue).

Acceptance and Commitment Therapy (ACT) Versus Cognitive Behavioural Therapy (CBT) for Fear of Cancer Recurrence (FCR) in Cancer Survivors and Their Spouses

Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors. FCR describes the fear, worry, or concern relating to the possibility that cancer will come back or progress, and is associated with reduced quality of life as well as other psychological symptoms. Approximately 60% of cancer survivors suffer from FCR, 20% of whom suffer from severe FCR. Relatives are also burdened by FCR, which in turn negatively affects the dyadic relationship as well as the survivors' quality of life. However, to date, there is a lack of evidence-based psycho-oncological couple interventions that focus on patients'/survivors' and spouses' FCR. Meta-analyses indicate the efficacy of mindfulness- and acceptance-based approaches such as acceptance and commitment therapy (ACT) for reducing FCR. In contrast to traditional Cognitive Behavioral Therapy (CBT) approaches, which, for instance, aim to change thoughts and feelings by cognitive restructuring, ACT aims to increase psychological flexibility and promotes a more detached, acceptance-based attitude toward thoughts and feelings, as well as a value-based life orientation. However, the empirical evidence for ACT in relation to FCR still needs to be investigated more thoroughly. This study, coping with fear of cancer recurrence (CARE-pilot), addresses these research gaps and aims to test the feasibility and preliminary efficacy of a manualized ACT couple intervention for outpatient cancer survivors (defined as cancer patients who completed primary treatment and were diagnosed \< 5 years ago) and their spouses. Sixty-four couples in which either survivor, spouse or both have elevated FCR will be randomized to either the ACT couple intervention (IG) or the traditional CBT couple intervention (active control group, CG). The IG and CG interventions consist of six psychotherapy sessions (four couple sessions and two individual sessions), the content of which is intensified in online modules between sessions (blended care). The primary endpoint of the feasibility study is the retention rate and achievement of recruitment targets. Using standardized measurements, changes in FCR, quality of life (primary endpoint of preliminary efficacy), and other psychosocial variables will be assessed at post-intervention and 3 months after the end of the intervention. The feasibility study represents the first step in evaluating the feasibility and the practicality of the couple interventions. The CARE-Pilot study aims to evaluate the feasibility and preliminary efficacy of an ACT-based couple intervention in reducing FCR, compared to a CBT-based couple intervention, in couples navigating cancer survivorship.

Routine LDL Exam For Cancer Survivors

This observational study will evaluate whether annual low-density lipoprotein cholesterol (LDL-C) testing is associated with improved cardiovascular preventive care and a lower risk of cardiovascular events among cancer survivors. The study will use nationwide health insurance and cancer registry data from Korea. Adults with a history of cancer who are alive at least 1 year after cancer diagnosis, have no prior major cardiovascular disease, and are not receiving statin therapy at the start of an eligible study period will be included. The investigators will compare cancer survivors who undergo LDL-C testing with similar cancer survivors who do not undergo LDL-C testing. Participants will not be assigned to receive testing or treatment by the investigators. Instead, routinely collected health care data will be analyzed. The main outcome will be major adverse cardiovascular and cerebrovascular events, including cardiovascular death, myocardial infarction, stroke, and coronary revascularization. The study will also examine whether LDL-C testing is associated with subsequent initiation of statin therapy. The findings may help determine whether routine lipid testing can support cardiovascular disease prevention as part of long-term survivorship care for people with cancer.

HematoCare: Feasibility of a Survivorship Care Plan for Hematologic Cancer Patients Undergoing HSCT

This is a feasibility study to implement a Survivorship Care (SC) Plan for patients with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT). The study evaluates if the intervention is feasible within the Italian national health system, focusing on retention rates, quality of life, unmet needs and caregiver burden

Project CASCADE: Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement

The purpose of this study is to implement a clinic-level cancer survivorship care delivery intervention in partnership with community health center clinicians, patients, and community representatives to test effectiveness of the intervention to improve patient and clinician outcomes and to evaluate implementation of the intervention using an iterative, concurrent mixed-methods approach guided by the Practice Change Model.

SBU-RESET: RElaxation, Stress Reduction and Epigenetics Trial in Cancer Survivors

Cancer survivors can experience health issues that cause chronic illness and lower quality of life. Yoga is a well-known holistic approach to health and overall well-being. Mindfulness has many benefits, including improved focus and less stress. This study aims to evaluate if yoga and/or mindfulness has a positive effect on cancer survivors social, emotional and physical well-being as well as their epigenetics. Epigenetics is how the environment can effect your genes; not by changing our DNA, but by turning genes on or off.

KanSurvive 2.0: Testing Enhanced Models of Cancer Survivorship Care for Rural Cancer Survivors in Primary Care Practice

Rural cancer survivors experience a higher risk of negative health outcomes and require coordinated care to address the many effects of cancer and its treatment. Primary care providers recognize the importance of providing high-quality, evidence-based survivorship care and are well-positioned to meet survivor needs, however, these needs are often unmet due to limitations in knowledge, lack of resources, and administrative demands. Practical strategies are needed to help PCPs improve cancer survivorship care, and this proposal will test implementation strategies to optimize the adoption of evidence-based practices for cancer survivorship care in rural primary care settings.