Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Melanoma

Head and Neck Neoplasms

Thoracic Neoplasms

Genital Neoplasms, Female

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neuroendocrine Tumor

Neuroepithelioma

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer

Participants will be enrolled into either IM@Home or enhanced usual care for the study duration of 12 weeks.

IM@Home is an online mind-body program consisted of a series of virtual, synchronous classes that offer a variety of rigorously tested mind-body therapies led by an Integrative Medicine Service (IMS) clinical therapist. The virtual mind-body group therapy sessions will be conducted using Zoom video conferencing platform.

IM@Home

Patients in the enhanced usual care will receive usual care. In addition, once enrolling into the trial, they will be given a handout to encourage them to visit the MSK's multimedia page on the Integrative Medicine website to access pre-recorded, on-demand meditation videos/audios

Enhanced usual care

Jun Mao, MD, MSCE

Tony Hung, MD

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.

A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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.

Memorial Sloan Kettering Cancer Center

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Brain Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Rectal Neoplasms

Urinary Bladder Neoplasms

Liver Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Esophageal Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Liver Diseases

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Breast Diseases

Esophageal Cancer

Pancreatic Cancer

Quality of Life

Hematinics

All Drugs and Chemicals

Liver Extracts

Radiation therapy on the CE marked and FDA approved MR-Linac

Radiation therapy

Tessa Leer

Tom Colonias

Clifton D Fuller

William A Hall

Sweet Ping

Robbe van den Begin

Arjun Sahgal

Michael Velec

Tine Schytte

Cihan Gani

Stefano Magrini

Filippo Alongi

Marlies N Nowee

Paul Jeene

Peter de Boer

Linda Kerkmeijer

Helena M Verkooijen, Prof, Dr

Shaista Hafeez

Ananya Choudhury

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

Rationale: Radiation therapy has become indispensable in cancer treatment. However, it is associated with severe side effects. Innovation in radiation therapy has resulted in the development of MR-guided radiation therapy (MRGRT) which allows high precision radiotherapy under real time MR visualization. High precision MRGRT has the potential of dose escalation and margin reduction and may potentially lead to higher cure rates and less toxicity. MRGRT can be delivered by the MRI guided Linear Accelerator (MR-Linac) which integrates a state-of-the-art linear accelerator, 1.5T diagnostic quality MRI and an online adaptive workflow.

Objective: The Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) aims to accelerate the technical and clinical development of Anatomic and Biologic MRGRT and facilitate the evidence-based introduction of the MR-Linac into clinical practice. In MOMENTUM, technical and clinical data are gathered in order to optimize software, evaluate treatment outcomes, toxicities and progression free, disease free, and overall survival per disease site, and create a repository of anatomical and biological MR sequences to develop new features.

Study design: A multi-institutional, international observational cohort study. Study population: Cancer patients ≥ 18 years receiving treatment and/or imaging on an MR-Linac machine are eligible for enrollment.

Main study parameters/endpoints: MOMENTUM will collect technical and clinical patient data. The technical patient data is defined as data generated by (the use of) the MR-Linac and will include data collection during scans performed during routine care as well as research MRIs. Clinical data will be categorized into six classes: demographic, disease characteristics, treatment classifiers, toxicity outcomes, cancer control outcomes and PROs.

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

Progression free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

Disease-free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.

Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.

Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive, and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.

Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.

Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.

Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.

Clinical tumor response in participating patients is obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.

Pathological tumor response in participating patients who undergo surgery are obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.

Disease-specific toxicity is obtained from the hospital information system.

The Netherlands Cancer Institute

Sunnybrook Health Sciences Centre

M.D. Anderson Cancer Center

The Christie NHS Foundation Trust

Royal Marsden NHS Foundation Trust

Medical College of Wisconsin

Elekta Limited

Odense University Hospital

Radboud University Medical Center

Radiotherapiegroep

Jules Bordet Institute

University Hospital Tuebingen

Radiotherapeutic Institute Friesland

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer	NCT05053230	Head and Neck C... Head and Neck T... Thoracic Tumor Thoracic Cancer Gynecologic Can... Gynecologic Tum... Melanoma	IM@Home Enhanced usual ...	18 Years -	Memorial Sloan Kettering Cancer Center
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study	NCT04075305	Oncology Breast Cancer Prostate Cancer Gynecologic Can... Brain Tumor Brain Cancer Gynecologic Tum... Prostate Tumor Prostate Neopla... Breast Tumor Radiation Toxic... Quality of Life Rectal Cancer Rectal Tumor Rectal Neoplasm... Lung Cancer Lung Tumor Lung Neoplasm Esophageal Canc... Esophagus Cance... Esophageal Tumo... Esophageal Neop... Esophagus Tumor Esophagus Neopl... Pancreatic Canc... Pancreatic Tumo... Pancreatic Neop... Head and Neck C... Head and Neck N... Head and Neck T... Tumor Neoplasms Bladder Cancer Bladder Neoplas... Liver Cancer Liver Neoplasms Liver Metastase... Oligometastases	Radiation thera...	18 Years -	UMC Utrecht

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