Head and Neck Cancer Clinical Trial
— IMPROVEOfficial title:
Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
The purpose of this study is to find out whether the Integrative Medicine at Home (IM@Home) program can help reduce patients' symptoms (such as tiredness, pain, or insomnia) and improve their satisfaction with treatment for their disease. The IM@Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice. Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 20, 2024 |
Est. primary completion date | September 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years or older - Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer - Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion - Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) - Karnofsky score 60 or greater - Life expectancy greater than six months - English speaking Exclusion Criteria: - Cognitive impairment that would preclude response to study assessments or require the use of Legally Authorized Representatives - Unwilling to accept random assignment - Concurrently enroll onto ongoing competing trials of integrative medicine interventions with symptom/toxicity as primary outcome. Note, however, patient will be allowed to enroll on other therapeutic protocols |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Fatigue Severity from the Brief Fatigue Inventory (BFI) | Primary outcome will be measured by the average fatigue severity measured by the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument designed to assess one construct of fatigue severity in cancer and non-cancer populations. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes."59 A composite fatigue severity score can be found by averaging the 9 item scores. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Recruiting |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 | |
Active, not recruiting |
NCT03688646 -
Efficacy of ONS Supplementation in HNC Outpatient Under Treatment
|
N/A |