Survivors

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

This research aims to monitor participants who previously received TSC-100 or TSC-101 T-cell receptor engineered T-cell (TCR-T) therapies in the TSCAN-001 study. The goal is to assess the long-term safety and efficacy of these investigational treatments over a 15-year period following their administration, focusing on people treated for conditions such as AML, ALL, and MDS. Participants will not receive any new study drug during this long-term follow-up study. Instead, they will be observed after completing the initial TSCAN-001 trial, while continuing any other cancer treatments as necessary. Monitoring will include a period lasting 15 years from the date of their original TCR-T cell therapy. During the study, participants will be evaluated for treatment-emergent adverse events to assess safety and tolerability. Researchers will also monitor overall survival, relapse-free survival, and progression-free survival over the 15 years. This observational study involves regular assessments to track long-term outcomes without administering additional investigational treatments.

Researchers are evaluating the use of CD19 CAR-T cell therapy in adult patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This open-label, multicenter study aims to assess how effective and safe this treatment is for this specific group of leukemia patients. Additional goals include studying how the CAR-T cells grow and persist in the body, as well as their effect on B-cell levels. Participants will receive an intravenous infusion of CD19 CAR-T cells at a dose of 2 x 10^6 CAR+ T cells per kilogram of body weight. The study includes approximately 50 adult patients and is designed as a single-arm trial without a comparison group. The treatment is administered once, followed by monitoring and evaluation periods. During the study, patients will be closely monitored for treatment response and safety. Key assessments include measuring the complete molecular response rate 28 days after infusion and tracking outcomes such as leukemia-free survival, overall survival, and relapse incidence over two years. Patients will undergo blood tests, genetic testing, heart function evaluations, and be observed for any infections or other health changes. Participation involves signing informed consent and agreeing to contraception measures if of childbearing potential.

Researchers are investigating the use of hyperbaric oxygen (HBO) therapy to improve umbilical cord blood (UCB) stem cell transplant outcomes for blood and lymph gland cancers such as AML, NHL, Hodgkin Disease, and myelodysplastic syndrome. UCB transplant has advantages like easier access and lower risk of infections and graft versus host disease, but challenges include limited stem cell doses and problems with homing, where stem cells lodge in the bone marrow. This study aims to see if HBO given before transplant can improve homing and engraftment by reducing a hormone that may impair this process. Participants in this randomized phase II trial will be assigned to either receive hyperbaric oxygen therapy or no additional intervention before their UCB transplant. HBO therapy involves breathing 100% oxygen in a pressurized chamber at 2.5 times normal atmospheric pressure. The study compares time to neutrophil recovery and other blood count and transplant success measures within 100 days after transplant between the two groups. Participants will be monitored closely with blood tests to track recovery and engraftment, including neutrophil and platelet counts and donor cell presence. Safety assessments and evaluations of transplant outcomes will occur regularly during the first 100 days post-transplant. The study runs until June 2027 and aims to provide important information on whether HBO therapy improves transplant success and immune recovery.

Researchers are evaluating whether using a digital smartphone application can help adults with chronic kidney disease (CKD) better follow the 2024 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The study focuses especially on young adults transitioning from pediatric to adult nephrology care, who face higher risks and challenges during this vulnerable period. The research aims to improve treatment adherence and health outcomes by addressing gaps in current care and guideline implementation. Participants will use a modified version of the St. James's Hospital Renal App, which has been adapted to align with the KDIGO 2024 guidelines. The app provides tailored recommendations, reminders, educational materials, and collects patient-reported outcomes. The study uses a randomized stepped wedge design where patients receive first exposure and later continued use of the app. The intervention supports healthcare providers by highlighting opportunities for evidence-based therapies and helps patients manage their care digitally. During the study, participants will be monitored for changes in adherence to KDIGO guidelines over 18 months. Assessments will include patient engagement, clinical data integration via electronic health records, and patient-reported measures. The app also supports appointment management and medication reminders, aiming to enhance self-management and slow CKD progression. The research includes diverse patient subgroups and considers cultural and linguistic needs to promote equitable care.

Researchers are evaluating how music therapy and cognitive behavioral therapy (CBT), both delivered virtually, may reduce anxiety in people who have survived cancer. This study also aims to understand if factors like age, sex, race, education, and expectations about therapy affect how well participants respond to these treatments. The trial is a Phase 4 study comparing these two non-drug therapies for cancer-related anxiety. Participants will be randomly assigned to receive either music therapy or cognitive behavioral therapy. Both treatments consist of seven weekly 60-minute group sessions conducted through a secure online platform (Zoom). Music therapy sessions involve personalized musical experiences guided by certified music therapists, including relaxation and musical engagement activities. CBT sessions focus on the connection between thoughts, behaviors, and emotions, led by licensed mental health providers. The study also includes a subgroup completing optional interviews and follows all participants for 26 weeks. Before randomization and at several points up to 26 weeks, participants will complete assessments measuring anxiety using the Hospital Anxiety and Depression Scale (HADS). Researchers will track changes in anxiety scores at 8 and 26 weeks. Participants must have access to Zoom and a private location for sessions. Safety and adherence are monitored throughout, with the study sponsored by Memorial Sloan Kettering Cancer Center.

Researchers are studying how thinking and memory abilities change over time in women who have survived breast cancer compared to women of the same age without cancer. The study looks at mental functions like memory, attention, and how information is processed. It aims to understand differences in cognitive function as people age, especially focusing on breast cancer survivors. Participants will complete a one-time, remote cognitive testing session using the CogSuite Neurocognitive Battery, which includes online tests of memory and thinking skills, along with standard neuropsychological measures. Additionally, participants will provide saliva samples by mail to analyze their Apolipoprotein E (APOE) gene status. Both breast cancer survivors and healthy volunteers will undergo this assessment. During the study, participants will answer questions about their demographics and health, and complete cognitive tests remotely. The primary measurement is to examine cognitive effects within 45 days of consenting. Researchers will also measure smoking exposure levels within the same timeframe. The study is observational and involves no treatment; participation is remote and designed to be convenient, with all activities completed once.

Researchers are evaluating whether combining motivational sessions with time-restricted eating (TRE) can help adult survivors of childhood cancer lose weight and reduce cardiometabolic risk. The study compares this approach to the usual care, which consists of reviewing educational materials and monthly weight measurements. This research focuses on weight management and does not provide treatment for any cancer or disease. Participants in the intervention group will gradually build up to a daily 16-hour fasting period, avoiding calorie-containing foods and drinks during this time. They will receive motivational coaching calls bi-weekly for the first three months, then monthly, along with daily text reminders and monthly weight checks. The comparison group will receive standard educational materials and monthly weight monitoring through an online platform. During the study, participants will complete questionnaires about health beliefs, worry, and physical activity. They will also provide dried blood spot samples at home to measure glucose, insulin, hemoglobin A1c, and lipids. Weight and other body measurements will be collected remotely. The main outcome is the percent change in weight after 12 months, with additional measures including changes in glucose, insulin, and hemoglobin A1c levels. The study will monitor participants over a 12-month period with regular check-ins and data collection.

Researchers are evaluating a new combination treatment using GI-102 and GIB-7 to target key aging-related issues such as immune system aging, metabolic problems, and gut-brain-muscle interactions. This Phase 2a study focuses on healthy adults and cancer survivors to explore whether this dual approach can support healthier aging by addressing inflammation and bodily system balance. GI-102 is an intravenous protein drug given once every four weeks, designed to reactivate the immune system and reduce inflammation associated with aging. GIB-7 is an oral synbiotic containing probiotic strains that support gut health, circadian rhythms, and muscle and cognitive function. Participants receive either the combination of GI-102 and GIB-7 or a placebo over an 8-week period in a randomized, single-blinded setup. Participants will undergo assessments of immune response, muscle function, sleep quality, and quality of life from the start through 10 weeks. Researchers will monitor safety by tracking adverse events and laboratory data. This study lasts about 10 weeks, including treatment and follow-up visits, to evaluate changes in immune cells and physical performance measures.

Researchers are evaluating a mobile health (mHealth) application designed to help children aged 9 to 16 who are in the early stage of cancer survivorship, along with their primary caregivers. The study aims to see if using this symptom management app can improve children's physical function, reduce anxiety, depression, fatigue, and pain interference, and enhance peer relationships. It also assesses whether caregivers experience better quality of life after using the app. This randomized controlled trial includes personalized nurse support and is sponsored by the Chinese University of Hong Kong. Participants in the intervention group will use the mHealth app for 12 weeks, which provides interactive symptom management support guided by the theory of unpleasant symptoms. The app includes educational materials about cancer treatment side effects and symptom management. Caregivers and children will communicate with nurses through the app, while participants in the wait-list control group will receive the same intervention after completing all assessments, ensuring fair access. During the study, children and their caregivers will complete questionnaires at baseline and monthly for three months using the app's electronic system. Researchers will conduct semi-structured interviews to assess the app's usability, feasibility, and acceptability. The primary outcome is the severity of the child's symptoms measured three months after starting the intervention. Secondary outcomes include symptom severity at one and two months and caregiver quality of life measured monthly. The total participation spans at least three months following the intervention start.