Lymphoma Clinical Trial
Official title:
Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment
Verified date | January 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - To be eligible, patients must be: age 18 or older - Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, head and neck cancer, or lymphoma - Within two weeks of starting treatment - Planning to receive care at Massachusetts General Hospital (MGH) - Verbally fluent in English - Residing within 50 miles of Massachusetts General Hospital Exclusion Criteria: - Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Medically Home |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants requiring a hospital admission or emergency department visit | Compare the difference between study arms using Fisher's exact tests, and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender). | baseline to 6 months | |
Secondary | Proportion of days participants spend outside of the hospital during the study period | Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Proportion of patients needing an urgent visit to clinic | Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Rate of treatment delays | Compare rates of treatment interruptions (e.g. delays) using Fisher's exact tests and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender). | baseline to 6 months | |
Secondary | Comparison of dose intensity | Compare dose intensity using linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Change in symptom burden (ESAS) | Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline up to 6 months | |
Secondary | Change in quality of life (FACT-G) | Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Change in psychological distress (HADS) | Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Change in care satisfaction (FAMCARE) | Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Change in Activities of Daily Living (ADLs) | Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months | |
Secondary | Change in Instrumental Activities of Daily Living (IADLs) | Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender). | baseline to 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |