Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Wasting Syndrome

Cachexia

Syndrome

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

2 g EPA/DHA via fish oil daily Regular dietary counselling Twice weekly strength and cardiovascular exercise

2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises

multimodal

Mette Holst, PhD

A single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. The effects of the intervention is compared to a historical control group

In a single arm intervention study, we will provide a multimodal intervention consisting of dietary counselling, physical exercises plan as well as fish oil.

The target of the dietary counselling is:

* 30 kcal/kg/d (in patients with BMI \<30) or 25 kcal/kg/d (in patients with BMI =\> 30)
* at least 1.0 g protein/kg/d
* three daily meals of at least 20 g of protein
* restrict overnight fasting to a maximum of 11 hours

The initial dietary counselling is at the first cycle of anti-neoplastic treatment. The patient will be provided an individual plan to meet the dietary targets tailored to the individual preferences and symptoms. At every cycle of anti-neoplastic treatment, the plan will be adjusted if needed. At every week the patients will be prompted by telephone to comply with the dietary plan.

The physical exercise consists of two exercises:

* strength training: a progressive sit-to-stand exercise which is a lower extremity exercise.
* cardio-vascular training: a progressive brisk walking plan. Patients are prompted to execute both exercises twice weekly. The individual targets are set at the first cycle of anti-neoplastic treatment and adjusted during the trial.

Fish oil:

The patients are instructed to ingest 10g of liquid fish oil (consisting of 2 g EPA/DHA) or 8 capsules of fish oil (consisting of 2 g EPA/DHA)

This is a single arm intervention study, comparing the results to that of a historical control Group.

Multimodal Intervention for Patients With Non-small Cell Lung Cancer

Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study

Recruitment rate is measured by dividing the number of patients consented by the number of patients screened

Retention rate is measured by dividing the number of patients completing the trial with the number of patients consented

The overall compliance was defined successful if at least half of the included patients reached at least 75 % of the nutrient target, consumed at least 75 % of the fish oil and conducted at least 50 % of the physical exercises

Change in skeletal muscle was measured using CT scans, analysed at the 3rd lumbar vertebra, expressed as actual change in square centimeter. Using an ordinal logistic regression model, patients were ordered in three Groups (muscle wasting: loss of at least 6 cm\^2 ; muscle maintenance: +/- 5.9 cm\^2; muscle gain: gain of at least 6.0 cm\^2). The baseline variables included in the model are age, gender, tumor stage, type of treatment, performance status, inflammatory score (mGPS) and cachexia. The possible prognostic factors included in the model is change in body weight, adherence to the anti-neoplastic treatment plan, treatment response, compliance to the multimodal intervention, number of Nutrition impact symptoms, days in between CT scans, energy and protein intake.

The change in body weight (measured at baseline and at the end of the trial using body weight scales, expressed as %

Change in skeletal muscle (measured using CT scans, expressed as actual muscle change at the 3rd lumbar vertebra in mean (SD) cm\^2

expressed as number of patients. Gaining defined as at least +6 Square centimeter skeletal muscle. Maintaining defined as: +/- 5.9 Square centimeter skeletal muscle. Wasting defined as: at least -6 Square centimeter skeletal muscle

assessed by timed-up-and-go test (expressed in number of seconds) and assessed by 30 seconds sit-to-stand test (expressed as number of stands).

Aalborg University Hospital

Ph.D. student

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

sentinel lymph node operation using radioisotope in the breast cancer patients

sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients

Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation

the mixture including indocyanine green

Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation

radioisotope

So-Youn Jung

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

1. Multimodal method enables to increase identification rate of SLNB
2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Indocyanine green Advantages: provides visualization of sentinel lymph node without incision

Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes

Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer

From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).

The number of participants with sentinel lymph node detection is assessed up to 13 months.

National Cancer Center, Korea

Medical Doctor

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Bevacizumab

Liver Extracts

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Chemotherapy regimens are determined based on the clinical experience of specialists

Chemotherapy regimens are determined based on the multimodal deep learning signature

AEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment

ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0

Jianmin Xu, Dr.

Wenju Chang, Dr.

Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.

Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

response rate will be assessed by local MDT every two months

progression free survival will be assessed by local MDT every two months during

overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment

Fudan University

Head of Colorectal Surgery

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.

The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.

The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.

The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.

The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.

The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.

Letter and informational sheet

The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.

Email

The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.

Phone

The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.

Multimodal

Jennifer Potter, MD

The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.

To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center

The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).

Fenway Community Health

Principal Investigator

Usual Care / Opportunistic Screening

The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.

Letter and informational sheet: The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.

Letter and Informational Sheet

The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.

Email: The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.

The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.

Phone: The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.

The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.

Multimodal: The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multimodal Intervention for Patients With Non-small Cell Lung Cancer	NCT04161794	Cachexia; Cance...	multimodal	18 Years -	Aalborg University Hospital
Multimodal Intervention for Patients With Non-small Cell Lung Cancer	NCT04161794	Cachexia; Cance...	multimodal	18 Years -	Aalborg University Hospital
Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer	NCT01856452	Breast Neoplasm...	the mixture inc... radioisotope	20 Years -	National Cancer Center, Korea
Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis	NCT05354674	Colorectal Canc... Liver Metastase...	Bevacizumab	18 Years - 79 Years	Fudan University
Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients	NCT02427399	Uterine Cervica...	Letter and info... Email Phone Multimodal	21 Years - 64 Years	Fenway Community Health

Spots Global Cancer Trial Database for multimodal

Every month we try and update this database with for multimodal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for multimodal

Every month we try and update this database with for multimodal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for multimodal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.