Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Syndrome

Pain

Somatoform Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Not applicable. No intervention will be done. it is an observational study assessing pain after mastectomy and the quality of life as assessed from validated questionnaires given to the patients at regular intervals

Non interventional study

APARNA S CHATTERJEE, MD,FCARCSI

Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers in women. Incidence rises in early thirties, peaks at 50-64 years. Approximately 48% are below 50 years of age. Most present when symptoms develop, so are 2B and beyond. Treatment depends on the stage of the disease. Surgical removal of the tumour is part of the treatment attempting a cure.

Simple mastectomy involves removal of breast tissue without axillary lymph node dissection or removal of chest wall muscles. Radical mastectomy involves removal of the entire breast, skin, pectoralis major and minor muscles and ipsilateral axillary lymph nodes. Modified radical mastectomy involves removal of the breast and ipsilateral axillary lymph nodes. The pectoralis muscle is preserved. Breast conserving surgery involves removal of tumour with or without axillary dissection. The extent of surgery tells us about the nerve damage, local tissue handling. For example operating in upper and outer quadrant of breast and axilla increases nerve handling in that particular region. Local radiation also plays a role.

Persistent pain after mastectomy was first reported in the 1970s by Wood and defined by International Association for Study of Pain (IASP) as pain in the anterior aspect of the thorax, axilla, and/or upper half of the arm beginning after mastectomy or quadrantectomy and persisting for more than three months after surgery and known as Postmastectomy pain Syndrome (PMPS). It is a common problem, with a 25- 60% incidence. The pain is described as burning or tenderness with paroxysms of lancinating, shock-like pain, and also described by some as dysesthesia (perception of non noxious stimuli as painful). Risk factors for PMPS include age, raised Body mass index (BMI), severity of postoperative pain, type of surgery, susceptibility to pain with a history of other pains such as headache and dysmenorrhoea. Axillary hematoma and postoperative radiotherapy have also been implicated in the development of PMPS.

Tata Memorial Hospital, is a tertiary cancer institute in India. Around 4000 patients with suspected breast cancers register annually at the hospital and approximately 2800 breast cancer surgeries are performed yearly. Very few studies on PMPS in Indian population exist. We therefore plan to identify the incidence of PMPS in our patients and also the severity of pain along with its impact on daily function and quality of life

Tata Memorial Hospital, a 629 bed tertiary cancer institute conducts approximately 6000 surgeries per year. Approximately 4000 (4239 in 2015) patients with suspected breast cancers register annually at the hospital and around 2800 breast cancer surgeries are performed every year. Very few studies on PMPS in Indian population exist. The investigators therefore, aim to identify the incidence of post mastectomy pain syndrome PMPS) in this population. The investigators also aim to identify the severity of postmastectomy pain along with its impact on daily function and quality of life.

STUDY DESIGN:

Prospective study over 12 months with follow up until 6th month from enrollment with interim analysis in the month of November for presentation of the CoPI's thesis.

MATERIALS \& METHODS:

Prospective study over a period of 12 months from commencement of study after Institutional ethics committee approval, at Tata Memorial hospital and ACTREC. Female patients scheduled for undergoing surgery for breast cancer conservative and radical and willing to participate will be enrolled in the study after obtaining a written informed consent. Pain scores will be assessed using Numerical rating scale \[with pain score 1-3 mild, 4 to 6 moderate and 7 and above severe\]. History of predisposition to recurrent headaches and dysmenorrhea will be noted. Details of disease stage, chemotherapy and/or radiotherapy will also be documented from the Electronic medical records. Analgesia will be managed by the primary surgical team as is currently being done. The analgesia administered to the patient will also be recorded. participants noted to have moderate to severe pain despite analgesics prescribed by the surgical team will be referred to the acute pain service (APS) for further management.

Postoperative pain severity both the average \& worst pain will be recorded at discharge from hospital, 1st, 4th and 6th month after the surgery. The Details of postoperative pain analgesic use and effect on daily function will be documented with the help of postal cards with questionaires in envelop addressed to the investigators. Study will emphasize on the type, severity, the site of pain whether, lateral or anterior chest wall, axilla, ipsilateral medial upper arm or back, the type of pain (burning, tingling, shooting, stabbing etc) and effects on daily function and quality of life. Details of postoperative hematoma, infection, local recurrence will also be recorded from the history, electronic medical records and documents of participants. Details of postoperative chemotherapy and radiation will also be obtained from patient's notes and the electronic medical record All participants will be administered the short form of the Brief Pain inventory \[BPI\], EORTC QLQ 30, preoperatively, at 1 month, 4 months \& 6 months after surgery.

The Brief pain inventory {BPI} (obtained with permission from MD Anderson), which assesses the severity of pain and impact of pain on daily functions will be administered to the participant in the language familiar to them, preoperatively, at 1 month, 4th and 6th month postoperatively. The short form comprises of nine questions related to the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.It has been widely used and validated in several languages the world over.

EORTC QLQ \[Quality of life Questionaries \] is an integrated system for assessing quality of life \[health related \]. This self administered questionnaires incorporates five functional scales, physical \[PF\], role \[RF\], cognitive \[CF\], emotional \[ef\], and social; three symptoms scale for fatigue, pain and nausea/vomiting; a global health quality of life scale and several single items for financial impact and additional symptoms like diarrhea, appetite loss, sleep disturbance. This would help identify the quality of life of the participants and its affection.

If a participant cannot follow up at the said intervals, the pain scores would be obtained telephonically and the BPI, EORTC QLQ 30 form in prepaid envelopes would be given to them at discharge which they would have to duly fill in and post them to the given address at the appropriate intervals. If the next follow up to the hospital coincides with the 4th or 6th postoperative month, the participant will visit the pain clinic for an assessment and completing the BPI.

Postmastectomy Pain Syndrome in an Indian Cancer Hospital

Post Mastectomy Pain Syndrome at an Indian Tertiary Cancer Centre: Incidence, Pain Severity, Impact on Daily Function and Quality of Life

presence of pain around the mastectomy site and ipsilateral arm after the mastectomy

How severe the pain is after mastectomy from the Pain intensity obtained from the Brief Pain inventory questionnaire

How severe the pain is after mastectomy from the pain intensity obtained from the Brief Pain inventory questionnaire

How the pain after mastectomy per se affects day to day functioning of the patient and how the quality of her life is affected. The impact of pain on daily life will be identified from the Brief Pain inventory questionnaire which the patient would have to complete at this time point.

The impact of the mastectomy on Quality of life of the patient would be assessed from the EORTC-QLQ 30 questionnaire completed by the patient

How the pain per se affects day to day functioning of the patient.The impact of pain on daily life will be identified from the Brief Pain inventory questionnaire which the patient would have to complete at this time point.

The impact of the mastectomy on the quality of life of the patient would be assessed from the EORTC-QLQ 30 questionnaire completed by the patient at his time point.

How the pain per se affects day to day functioning of the patient .The impact of pain on daily life will be identified from the Brief Pain inventory questionnaire which the patient would have to complete at this time point.

the impact of teh mastectomy on the quality of life of the patient would be assessed from the EORTC-QLQ 30 questionnaire completed by the patient at this time point.

Tata Memorial Centre

Professor

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

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

Neuroendocrine Tumor

Neuroepithelioma

Alfonso Medela, MsC

Jordi Barrachina, PhD

Jesús Gardeazabal, PhD

Rosa María Izu, PhD

Juan Antonio Ratón Nieto, PhD

Ana Sánchez Diez, PhD

Andy Aguilar, MsC

Taig Mac Carthy, MsC

Rosa María Ize, PhD

The goal of this Cross-sectional analytical observational study of clinical case series is to validate a Computer-aided diagnosis software developed by AI Labs Group for the identification of cutaneous melanoma in images of lesions taken with a dermatoscopic camera. This study will be carried out in patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces University Hospital and Basurto University Hospital. The main questions it aims to answer are:

* If the AI algorithm developed by AI Labs group is a valid tool to identify cutaneous melanoma in dermoscopic images with high reliability.
* Comparing the device\&#39;s performance with dermatologists, with primary care physicians\&#39; assessment to be considered in later phases.
* Assessing the utility and feasibility of the device in adverse environments with technical limitations.

In this way, patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces and Basurto University Hospitals will be recruited. Patients in this study will not receive any specific treatment as part of the research protocol. In addition, they will continue their regular prescribed medications and treatments as directed by their primary healthcare providers. This study does not require doing a follow-up of the subjects. Every patient only gets their skin lesions photographed at the time of visit.

Introduction Cutaneous melanoma (CM), a type of skin cancer, has seen a significant rise in incidence and mortality. It\&#39;s particularly aggressive and can metastasize rapidly, making it resistant to chemotherapy and radiotherapy. However, early detection through simple surgical excision is highly treatable. Differentiating between benign and malignant pigmented lesions, especially during visual examination, is challenging.

Due to low public awareness and limited access to dermatologists, melanoma often gets diagnosed at a later stage. To address this, there\&#39;s growing interest in computer-aided diagnostics (CAD) using Artificial intelligence (AI) for early melanoma detection. AI technologies have shown competence comparable to dermatologists in classifying lesions from photographs. Machine vision and AI present a significant opportunity for improving diagnosis.

Preventive activities and early diagnosis campaigns have improved patient survival, pointing at the fact that AI-based devices to assess skin lesion malignancy and distinguish between micro melanomas and other skin lesions like nevus and lentigines may further increase patient survival. This study aims to clinically validate the detection of cutaneous melanoma using computer vision and machine learning applications.

Objectives Hypothesis A CAD system powered by with machine vision allows early and non-invasive diagnosis of cutaneous melanoma in-vivo.

Primary objective

To validate that the artificial intelligence algorithm developed by AI Labs Group S.L. for the identification of cutaneous melanoma in images of lesions taken with a dermatoscopic camera achieves the following values:

* Area Under the Curve (AUC) greater than 0.8
* Sensitivity of 80% or higher
* Specificity of 70% or higher

Secondary objective

To compare the performance of the artificial intelligence algorithm developed by the manufacturer with the performance of healthcare professionals of different specializations:

Dermatologists Primary care physicians Validate the usefulness and feasibility of the artificial intelligence algorithm developed by the manufacturer in adverse environments with severe technical limitations, such as lack of instrumentation or lack of internet connection.

PRIMARY CARE PHYSICIANS The study does not compare the performance of the device against Primary care physicians; it only focuses on dermatologists. However, it is widely known that dermatologists have a significantly higher diagnostic success rate in the detection of melanoma.

Population Patients with skin lesions of suspected malignancy seen at the Dermatology Department of the Cruces and Basurto University Hospitals.

Design and Methods Design This is an analytical observational case series study for the performance of a diagnostic test study. Measurements are performed in a single case, so it is a cross-sectional study.

Number of Subjects The initial number of subjects for the study was 40. However, due to the need for a balanced dataset (i.e., same number of melanoma and non-melanoma images), we considered it necessary to collect cases of nevus and/or other types of skin lesions if necessary. For this reason, the proposed number of subjects was increased to approximately 200 people, of which at least 40 present cutaneous melanoma.

At the time of this report, a total of 96 subjects have been included in the study, 70 from Basurto University Hospital and 26 from Cruces University Hospital.

Initiation Date The date of inclusion of the first subject was September 17th, 2020.

Completion Date The last subject of the initial sample of 40 participants was included on March 24, 2021.

The readjusted target sample size (200 participants) has not been reached yet, with 96 subjects included at the time of the report.

Duration This study is estimated to have a recruitment period of 10 months for the inclusion of the first 40 patients. The recruitment period is extended by 12 months for the inclusion of patients up to a total of 200, with a minimum of 40 melanomas.

The total duration of the study is estimated at 36 months, including the time required after recruitment of the last subject for closing and editing the database, data analysis and preparation of the final study report.

Methods

All the skin lesions are photographed following these technical indications:

Uncompressed image format, such as PNG, HEIC or TIFF. Taken with the DermLite Foto X dermatoscope of the 3Gen Inc.

Taken from a Smartphone with the following characteristics:

With a camera with a minimum resolution of not less than 13 megapixels.

Taken with one of the following models:

* Google Pixel 3 and Google Pixel 3 XL.
* Samsung Galaxy Note 10, Samsung Galaxy S10, Samsung Galaxy S10E
* iPhone X and below
* Disabling all image post-processing, such as HDR, portrait mode, color filters or digital zoom.

On a monthly basis, the research team collects the images and verifies their correctness. If any image is not of sufficient quality, the investigator repeats the photograph. The research team also collects diagnostic data from the expert dermatologists.

Clinical Validation Study of an AI-based CAD System for Early Non-Invasive Detection of Cutaneous Melanoma

Clinical Validation Study of a CAD System With Artificial Intelligence Algorithms for Early Non-invasive Detection of in Vivo Cutaneous Melanoma

Number of images that every patient upload to the web app with tha AI algorithm

Quality of the uploaded image by patient. A bad quality will not be accepted for the study and the patient will be asked to upload an image with a better quality

Sensitivity of the algorithm to detect the presence of melanoma or not

Servicio Vasco de Salud Osakidetza, Spain

Osakidetza

Hospital de Basurto

Hospital de Cruces

AI Labs Group S.L

Nutritional and Metabolic Diseases

Wasting Syndrome

Cachexia

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Supervised patient-tailored intensity-modulated physical training

1. Supervised Physical Training in SeniorGym for 12 weeks: 1) Aerobic exercise: Patient-tailored intensity-modulated ergometer training for the limbs; 2) Resistance exercise: Patient-tailored resistance exercise by Theraband for the limbs
2. Nutrition intervention for 24 weeks: Dietitian consultation, education and intervention for 24 weeks

Physical training

Chih Chieh Yen, MD

Yi Hsuan Lin

Jui Hung Tsai, MD

I Ting Liu, MD

Ying Tzu Huang, MD

Shuen Ru Yang, MD

Sheng Fu Liang, Ph.D.

Li Chieh Kuo, Ph.D.

Chih Chun Lin, Ph.D.

The goal of the clinical trial is to evaluate the feasibility and efficacy of physical training for elderly cancer patients at risk of cancer cachexia. The main questions it aims to answer are:

* Whether a physical training program is feasible in elderly cancer patients with cachexia?
* What is the efficacy of a physical training program in reducing the severity of cancer cachexia in elderly cancer patients?

Participants will receive a 12-week supervised patient-tailored intensity-modulated physical training and being assessed for the severity of cancer cachexia before and after the training.

The trial is to investigate the feasibility and efficacy of an artificial intelligence-based patient-tailored intensity-modulated physical training for cancer patients aged over 65 at risk of cancer cachexia. The primary endpoint is simplified cancer CAchexia SCOre (MiniCASCO) reduction. Secondary endpoints include geriatric assessment, physical activity and sarcopenia. This is an open-label, single-arm, single-center phase II investigator-initiated trial. The investigators assume a reduction of MiniCASCO by 10% after trial intervention. Under a statistical power of 80% and a probability of type I error at 0.1 (two-tailed), a minimal of 49 participants will be enrolled. All participants will receive a 12-week supervised physical training and nutritional intervention. Efficacy assessments will be conducted at baseline (week 0), post-intervention (week 12) and follow-up period (week 24). The investigators anticipate that the optimal patient-tailored training program is feasible and improves the symptoms and severity of elderly cancer cachexia. The results may shed light on the debilitating and burdensome condition and provide information on future clinical trials.

Physical Training for Elderly Cancer Patients With Cachexia

Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01): a Prospective Clinical Trial

The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.

Health-related quality of life:

A total of 10 standardized questions from EORTC-QLQ C30 are asked to the participants. The answers are graded as none/not at all, a little/slightly, average/moderately, or a lot/considerably and each question is given 0, 0.25, 0.75 or 1.0 point, respectively. A sum-up score of 0 to 10 will be recorded and of those with a greater score indicate a poorer quality of life.

Nutrition:

A total of six questions on food intake, weight loss, mobility, psychological stress/acute disease, the presence of dementia/depression, and body mass index will be graded. A total score, ranging from 0 to 14, will be recorded and of those with a score ≤ 11 indicate a nutritional deficit.

A simplified version for the scoring of the severity of cancer cachexia:

A total score of 0 to 100 points are recorded and graded as minimal (0 to 14), mild (15 to 28), moderate (29 to 46) or severe cachexia (47 to 100)

Geriatric assessment:

A total of 6 domains (cognitive, mobility, nutrition, visual, hearing and depressive symptoms) are included and be given a score of 1 on each if screened positive (a total score from 0 to 6). Of those who scored greater than 2 will be considered "impaired".

Hand grip strength, Gait speed, Body mass index, Sit-to-stand, Back stretch, Sit reach, Single leg stand, Up-and-go, 2-minute step, 6-minute walk test and Timed up-and-go:

A total of 11 items will be recorded and calculated for the percentage difference, which is equivalent to the {\[absolute change between week 12 (end of training) and week 0 (trial enrollment) testing result\] / week 0 testing result } x 100 %. A mean percentage difference of the 11 items, ranging from 0 to 100%, will be calculated and of those with a greater mean percentage difference indicate a greater post intervention change.

National Cheng Kung University

National Cheng-Kung University Hospital

Principal investigator

Blood and Lymph Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Patients interviews and questionnaires about CML symptoms once.

Importance of symptoms to CML patients rated by physicians, nurses, patients, and caregivers.

Patients questionnaires about CML symptoms over 1 year using M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML)

30 Minute Interview about what it is like to have CML, followed by symptom questionnaire, quality-of-life questionnaire, and demographic questions taking another 10 minutes for all 3 questionnaires.

Interview & Questionnaires

Questionnaire developed in Part 1 to rate the relevance of symptom items, given to 3-5 physicians, 3-5 nurses, 2-4 patients and their family caregivers, taking about 10 minutes.

Rating Questionnaire

Patient questionnaires about CML symptoms over 1 year, completed in person or using Interactive Voice Response (IVR) system every 2 weeks.

MDASI-CML Questionnaire

Loretta A. Williams, PHD, MSN

Objectives:

The objective of this study is to measure and delineate the symptom burden experienced by patients with chronic myeloid leukemia (CML).

The Primary Aim is to develop and validate an M. D. Anderson Symptom Inventory (MDASI) module (the MDASI-CML), compliant with FDA standards for patient-reported outcomes (PROs), to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with CML.

The Secondary Aims are:

1. to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with CML;
2. to assess the impact of symptom severity in CML on standard functioning and quality of life (QOL) measures including Eastern Cooperative Oncology Group (ECOG) Performance Status and single-item QOL scale;
3. to evaluate the MDASI-CML as an estimate of functional status and QOL in patients with CML;
4. to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with CML;

5, to define the qualitative symptom burden of patients with CML;

6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring symptom severity and interference with daily activities over time in patients with CML.

Part 1:

Interview:

If you agree to take part in this study, while you are at the clinic for a visit, you will be interviewed about what it is like to have CML. The interview should take about 30 minutes to complete.

Questionnaires:

After the interview, you will be asked to answer a symptom questionnaire, a quality-of-life questionnaire, and some demographic questions such as your age and marital status. It will take about 10 minutes to complete all 3 questionnaires.

Length of Study:

After you have completed the interview and questionnaires, your participation on this study will be over.

Additional Information:

The interview will be digitally recorded. The electronic record of the interview will not have your name linked to it and it will be kept on a secure server at M. D. Anderson Cancer Center that is password protected. All study materials will be destroyed after data analysis is completed and study results reported.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study.

Up to 218 participants will take part in this study. Up to 40 will be enrolled in Part 1 of this study. All will be enrolled at MD Anderson.

Part 3:

Symptom Questionnaires:

If you agree to take part in this study, you will complete a questionnaire about any symptoms you are having every 2 weeks for 1 year. On the questionnaire, you will be asked to rate the level of discomfort caused by the symptoms you are having and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your clinic visits every 3 months. In between visits, you will be called every 2 weeks to complete the questionnaire by an automated telephone system.

You will decide a convenient time and place for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. You may also call the automated system if you miss a call. If you are not reached by the automated phone system after several tries, the study staff will call you.

You will be given a secure user name and identification number to use with the automated phone system. You will be shown how the automated phone system works by the study staff.

Two (2) days after the first visit, you will fill out the symptom questionnaire again. You will take it home with you from the clinic with a pre-addressed, stamped envelope given to you by the research staff so you can return it. The research staff will also ask for your telephone number so that they may contact you and remind you to complete the questionnaire.

Quality-of-Life/Demographic Questionnaires:

At the first visit and the 3-month clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.

At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.

Opinion Questionnaire:

If you are 1 of the first 30 patients enrolled in the study, at the first visit you will also complete a questionnaire about your opinion of the symptom questionnaire. For example, you will be asked if the symptom questionnaire was easy to understand and to complete and if there were any other questions that should be included. The study staff will use your opinion to decide if other important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

You will be on study for 1 year.

Additional Information:

The questionnaires will only use your study number and will not have your name linked to them. All questionnaires and study data will be kept in a locked cabinet at all times. All study materials will be destroyed after data analysis is completed and study results reported.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study.

Up to 218 participants will take part in this study. Up to 160 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.

Symptom Burden in Chronic Myeloid Leukemia (CML)

Symptom Burden of Patients With Chronic Myeloid Leukemia (CML)

Novartis Pharmaceuticals

M.D. Anderson Cancer Center

It is the systematically designed Video Assisted teaching program to educate cancer patients receiving chemotherapy under the experimental group about the management of chemotherapy related side effects at home .It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including Nausea, vomiting, Diarrhea, Constipation, Fever, Mucositis, Skin changes, and Alopecia related distress.

The participants were given video when they come to oncology day care and instruct the participants to watch the video at home. Knowledge, self efficacy and severity of chemotherapy related side effects were assessed after one week.

The main aim of this intervention is to educate the cancer patients receiving chemotherapy regarding the management of chemotherapy related side effects.

It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including nausea vomiting , Diarrhea , Fever , Mucositis , Skin changes , and Alopecia related distress.

The participants were given video when they comes to the Oncology day care and researcher instructs the participants to watch the video and at the same time the doubts asked by the participants were cleared by the researcher.

Video Assisted Self Management Program

Standard of care

Seema Ms Bisht, Nursing

A study to assess the effectiveness of video assisted Self Management Program on chemotherapy side effects in terms of Knowledge, Self Efficacy and Severity of side effects among the Cancer patient receiving chemotherapy at Oncology day care ILBS , New Delhi.

Primary Objective:

1. To assess the Knowledge, Self Efficacy and Severity of side effects of chemotherapy related side effects in the Experiment Vs. Comparison group among the cancer patients receiving chemotherapy.
2. To compare the knowledge and self efficacy scores in Experimental Vs. Comparison group after video assisted SMP among the cancer patients receiving chemotherapy.
3. To compare the severity of chemotherapy related side effects in Experiment Vs. Comparison group before and after video assisted SMP among the cancer patients receiving chemotherapy.

Secondary Objective To find the correlation between knowledge and self efficacy scores among the cancer patients receiving chemotherapy under Experimental Group.

2. To determine the association of Severity of side effects with the knowledge and self efficacy scores among the cancer patients receiving chemotherapy.

3. To determine the association of knowledge, self efficacy with the socio demographic and clinical variables among the cancer patients receiving chemotherapy.

The study assumes that:

1. Video assisted teaching is an accepted teaching strategy and enhances teaching learning activities.
2. Patients may have limited knowledge about the management of side effects related to chemotherapy including nausea, vomiting, diarrhea, Constipation, dry skin, fever, alopecia related distress and pain.
3. Patients may have decrease severity of chemotherapy related side effects including nausea, vomiting, diarrhea, Constipation , dry skin, fever , alopecia related distress and pain. After the self management program.

Effectiveness A measure of the extent to which a specific intervention, procedure, regimen, or service when deployed in the field of routine circumstances, does it intended to do for a specific population. (Wojtezak, 2002) In this study, effectiveness refers to the degree to which the video assisted SMP is successful in the management of chemotherapy related side effects in terms of gain in Knowledge, self efficacy scores and reducing the severity of side effects among the cancer patient receiving chemotherapy.

Video Assisted Self Management Program It referred to an instructional aid which incorporates visual and auditory information on a topic for individual to understand and learn. (MedCrave 2016) In this study it refers to the systematically designed Video Assisted teaching program to educate cancer patients receiving chemotherapy under the experimental group about the management of chemotherapy related side effects at home .It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including Nausea, vomiting , Diarrhea ,Constipation, Fever , Mucositis , Skin changes , and Alopecia related distress.

Chemotherapy side effects It is the unintended effect occurring at normal dose related to the pharmacological properties. (WHO) In this study it refers to the commonly reported chemotherapy related side effects by the patients receiving chemotherapy including nausea vomiting, Diarrhea, Constipation, Fever, Mucositis, Dry skin, and Alopecia related distress in cancer patients after receiving chemotherapy.

Knowledge It is defined as the familiarity, awareness, or understanding of someone or something such as facts, skills or objects. (Plato) In this study it refers to the correct response of the patient to the questionnaire regarding the self management of the side effects of chemotherapy. It will be assessed by the Structured Questionnaire on self management of chemotherapy related side effects with 20 items. The scores will be analyzed in the form of means.

Cancer Patients Cancer Patient is defined as a person receiving or registered to receive medical treatment in the Hospital for Cancer. (American Cancer Society) In this study it refers to the person either male or female who is suffering from any type of cancer that includes but not limited to Head and Neck, Pancreas, Liver, Gall bladder, Breast, Stomach, and mouth cancer and receiving chemotherapy at Onco day care ILBS, New Delhi at the time of data collection.

Self Efficacy It refers to an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments. It reflects confidence in the ability to exert control over one's own motivation, behavior and social environment. (Bandura, 1977) In this study it refers to the level of confidence of the cancer patients about their ability to manage the chemotherapy related side effects at home. It will be assessed by the structured symptom management self efficacy tool consisting of Twelve items. The mean score of self efficacy will be used to compare the Experimental and Comparison groups.

Severity of Chemotherapy Related Side Effects It refers to the degree to which a single side effect affects the patient graded on a scale of three. (Aakshdeep batra AIIMS) In this study it refers to the magnitude or the intensity (Grading) of the chemotherapy related side effects among the cancer patients receiving chemotherapy. It will be assessed by the Common Terminology Criteria for the Adverse Events (CTCAE) Version -5 and the Chemotherapy related side effects will be assessed in terms of their presence and the severity from the day of last chemotherapy cycle to the day of present cycle. It will be a recall basis assessment.

Hypothesis

All hypotheses were tested at 0.05 level of significance:

H1: There will be a significant difference between the Experimental and comparison group in terms of their mean gain in knowledge scores after video assisted SMP as assessed by the structured knowledge questionnaire.

H2 : There will be a significant difference between the Experimental and Comparison group in terms of their mean gain in Self efficacy scores after video assisted SMP as assessed by the self efficacy scale.

H3: There will be a significant difference between the Experimental and Comparison group in terms of their mean scores of Severity of the side effects after video assisted SMP as assessed by the CTCAE criteria.

H4: There will be a significant correlation of knowledge and self Efficacy scores in Experimental group among the cancer patients receiving chemotherapy.

H5: There will be a significant association of severity of chemotherapy related side effects with the knowledge and self efficacy scores among the cancer patients receiving chemotherapy.

H6: There will be a significant association of knowledge and self efficacy scores with the sociodemographic and clinical variables among the cancer patients receiving chemotherapy.

Delimitations of the study The study was delimited to

• Patients who are receiving chemotherapy at Oncology Day care in ILBS, New Delhi.

Variables under Study Independent Variables In the present study, the independent variable was the Video assisted Self Management Program. The protocol used in this study was prepared after an extensive review of literature.

Dependent Variables In the present study, the dependent variables were Knowledge, self efficacy and severity.

Socio Demographic Variables In the present study, the socio demographic variables studied were Age, Gender, Marital status, Education, Occupation, Religion, Family monthly income.

Clinical Variables The clinical variables are Type of Cancer, duration of time since diagnosis, Last chemotherapy cycle received, Stage of cancer , No of present chemotherapy cycle received, Any Family members/ closed relatives / friends received chemotherapy ever , Any training received on management of side effects.

Research Settings The setting for the present study is Institute of Liver and Biliary Sciences. It is a super specialty hospital specialized in Liver and biliary sciences .The hospital has facilities like Emergency Unit, Transplant Intensive care Unit, Operation Theatres, Liver coma Intensive care Unit. The hospital also has the facility of Onco Day care where chemotherapy is provided.

The study was conducted at the Oncology Day care. The Oncology Day care unit is a 9 bedded unit. The rationale for selecting the setting was easy availability of the sample of interest , feasibility of conducting the study and familiarity with the setting.

Intervention Description of Video Assisted Self Management Program It is a intervention which was designed by the principal investigator In this study it refers to the systematically designed Video Assisted teaching program to educate cancer patients receiving chemotherapy under the experimental group about the management of chemotherapy related side effects at home. After extensive review of literature under the guidance of guide and Medical Oncologist. The Video Assisted teaching program was validated by the Medical oncologist and other experts.

The main aim of this intervention is to educate the cancer patients receiving chemotherapy regarding the management of chemotherapy related side effects.

It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including nausea vomiting , Diarrhea , Fever , Mucositis , Skin changes , and Alopecia related distress.

The participants were given video when they comes to the Oncology day care and researcher instructs the participants to watch the video and at the same time the doubts asked by the participants were cleared by the researcher.

Effectiveness of Video Assisted Self Management Program on Chemotherapy Related Side Effects .

Effectiveness of Video Assisted Self Management Program on Chemotherapy Side Effects in Terms of Knowledge, Self Efficacy and Severity of Side Effects Among the Cancer Patient Receiving Chemotherapy at Oncology Day Care

A structured 20 item knowledge questionnaire developed for assessment of knowledge among the cancer patients receiving chemotherapy at Onco day care Ilbs. The knowledge questionnaire will be self reported by the subjects.

The Structured Symptom-Management Self-Efficacy Scale derived from - Symptom-Management Self-Efficacy Scale Breast Cancer (SMSES-Breast Ca.) It was developed by SY Liang et al., in 2015 that measure perceived self efficacy in terms of respondent's ability to self manage the symptoms of chemotherapy. It is an 11-point Likert scale was used for each item that ranged from 0 (not confident at all) to 10 (completely confident), with higher scores representing higher perceived self-efficacy.

It consists of grades which are used to assess the severity of adverse events. Grades ranges from 0 to 5. The scores assessed by the researcher for the severity of side effects will be verified by the doctors on duty.

The Distress thermometer was developed as a simple tool to effectively screen for symptom of Alopecia related distress. It is a self reported tool using a 0-10 rating scale. The scale was explained to all the participants and participants were asked to circle or pick a number 0-10 from the drop down box that best describes how much distress patient have been experiencing in the past weeks including today.

Institute of Liver and Biliary Sciences, India

Diseases and Abnormalities at or Before Birth

Keratosis, Actinic

Keratosis

Congenital Abnormalities

Abnormalities, Multiple

Darier Disease

Precancerous Conditions

Skin Diseases, Genetic

Genetic Diseases, Inborn

All Drugs and Chemicals

Anti-Infective Agents

Dermatologic Agents

Antiemetics

Gastrointestinal Agents

Hyaluronic Acid

Salicylic Acid

Dimenhydrinate

Carbamide Peroxide

Emollients

Immunoglobulin A

KP Scoring Day Participants

Participants who attend the one-day scoring session in August 2022.

KP Follow-up Scoring (September)

Participants who attended the scoring day in August will be invited to attend a follow-up scoring session in September - October 2022. The purpose of this scoring session is to see how stable their condition is and take baseline photographs of their skin to monitor their condition.

Four assessors will score the participants in 5-minute intervals with the proposed scoring system KPAI and the KP-IGA. Participants will be offered free samples of Cerave Salicylic Acid Smoothing Cleanser and Cream to try.

KP Follow-up Scoring (November)

Participants who attend the September scoring session will be invited to return for another rescoring in November - December 2022 to see if there is any improvement in their KP and if the score is responsive to change.

Participants will be given free samples of Propaira 30% Urea exfoliating emollient and Propaira 20% Lactic acid exfoliating lotion to try.

KP Follow-up Scoring (December)

Participants who attend the November scoring session will be invited to return for another rescoring in December 2022 to monitor their progress, and see if there is any improvement in their KP and if the score is responsive to change.

The CeraVe Salicylic Acid (SA) Smoothing Cleanser is formulated with salicylic acid to help exfoliate the skin and remove dirt and dead skin cells on the skin without compromising or striping moisture from the skin's natural barrier, leaving the skin feeling clean, smooth and hydrated. This salicylic acid cleanser is also formulated to include hyaluronic acid to hydrate and retain moisture and 3 essential ceramides to moisturise and help support the skin's barrier.

CeraVe SA Smoothing Cleanser

The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides.

CeraVe SA Smoothing Cream

Propaira 20% Lactic Acid Exfoliating Lotion

30% Urea, 7% Glycerin to smoothen rough skin.

Propaira 30% Urea Exfoliating Emollient

The proposed score, Keratosis Pilaris Area Index (KPAI), is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100.

KPAI

A standard 5-point IGA score (0-4) defined specifically for KP

KP-IGA

Bianca Wills, BMedSci

Madeline Wang

Anna Wilson

Dédée Murrell

This validation study aims to develop a standardised investigator global assessment (IGA) score for keratosis pilaris and test the validity and reliability of the score through a one-day scoring exercise held at a private practice and compare it to a standard 0-4 IGA score specifically defined for keratosis pilaris.

This is a prospective validation study aiming to develop and validate a standardised IGA score for KP. Firstly, a preliminary score will be developed using deidentified photos of patients with KP. These photos will only be used to create the training slide for the assessors. The proposed score, Keratosis Pilaris Area Index (KPAI), is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100. This will be compared to a standard 0-4 IGA score, defined specifically for KP, known as a KP-IGA.

The one-day scoring exercise has been modified from the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) validation (Loh et al., 2014). It will take place at Premier Specialists, Kogarah, Sydney with all co-investigators conducting the study in person at this single study site. Each dermatologist and medical professional involved will receive training on using the scores through a slideshow of training photos prior to the live scoring session. Five dermatologists and four medical professionals will be randomly assigned to assess 20 KP patients in 5-minute intervals, using the proposed scoring system, KPAI, and the KP-IGA score. This data will be used to assess inter-rater reliability.

Each dermatologist or medical professional will be randomly assigned to rescore two patients after seeing other patients to minimise recall bias. The randomisation will be done by an investigator who is uninvolved in the scoring session and has had no interaction with both patients and assessors. Data gathered from this section is used to determine intra-rater reliability.

Every participant will also complete two QOL questionnaires: the DLQI/CDLQI and HADS. This data will be used to provide insight of patient's subjective perceptions of KP and the psychological impact it may have on them.

Participants who attended the scoring day will be invited to attend a follow-up scoring session in September - October 2022. The purpose of this scoring session is to see how stable their condition is and take baseline photographs of their skin to monitor their condition.

Four assessors will score the participants in 5-minute intervals with the proposed scoring system KPAI and the KP-IGA. Participants will be offered free samples of Cerave Salicylic Acid Smoothing Cleanser and Cream to try. They will be invited to return for another rescoring in November - December 2022 to see if there is any improvement in their KP and if the score is responsive to change.

In the November - December 2022 scoring session, participants will be given free samples of Propaira 30% Urea exfoliating emollient and Propaira 20% Lactic acid exfoliating lotion to try. They will be invited to return for a fourth scoring session in December to monitor their progress and see if the scores improve.

Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris

This study aims to develop and validate an IGA score for evaluating KP (KPAI) by determining the intra-rater and inter-rater reliability through testing the composite IGA score on patients and comparing it to a standard 0-4 IGA that will be defined specifically for KP.

The secondary aim of the study is to explore the impact KP may have on patients' QOL by using the (Child) Dermatology Life Quality (DLQI/CDLQI) Index questionnaires.

The secondary aim of the study is to explore the impact KP may have on patients' QOL by using the hospital anxiety and depression scale (HADS) questionnaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postmastectomy Pain Syndrome in an Indian Cancer Hospital	NCT03067922	Pain Syndrome Mastectomy Quality of Life	Non interventio...	18 Years - 80 Years	Tata Memorial Centre
Postmastectomy Pain Syndrome in an Indian Cancer Hospital	NCT03067922	Pain Syndrome Mastectomy Quality of Life	Non interventio...	18 Years - 80 Years	Tata Memorial Centre
Clinical Validation Study of an AI-based CAD System for Early Non-Invasive Detection of Cutaneous Melanoma	NCT06221397	Melanoma Melanoma, Skin		18 Years -	AI Labs Group S.L
Clinical Validation Study of an AI-based CAD System for Early Non-Invasive Detection of Cutaneous Melanoma	NCT06221397	Melanoma Melanoma, Skin		18 Years -	AI Labs Group S.L
Physical Training for Elderly Cancer Patients With Cachexia	NCT05915325	Geriatric Asses... Cancer Cancer Cachexia	Physical traini...	65 Years -	National Cheng-Kung University Hospital
Symptom Burden in Chronic Myeloid Leukemia (CML)	NCT01046305	Leukemia	Interview & Que... Rating Question... MDASI-CML Quest...	18 Years -	M.D. Anderson Cancer Center
Effectiveness of Video Assisted Self Management Program on Chemotherapy Related Side Effects .	NCT05368116	Cancer Patients	Video Assisted ... Standard of car...	18 Years - 65 Years	Institute of Liver and Biliary Sciences, India
Postmastectomy Pain Syndrome in an Indian Cancer Hospital	NCT03067922	Pain Syndrome Mastectomy Quality of Life	Non interventio...	18 Years - 80 Years	Tata Memorial Centre
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris	NCT05535517	Keratosis Pilar...	CeraVe SA Smoot... CeraVe SA Smoot... Propaira 20% La... Propaira 30% Ur... KPAI KP-IGA	12 Years - 80 Years	Premier Specialists, Australia
Effectiveness of Video Assisted Self Management Program on Chemotherapy Related Side Effects .	NCT05368116	Cancer Patients	Video Assisted ... Standard of car...	18 Years - 65 Years	Institute of Liver and Biliary Sciences, India

Spots Global Cancer Trial Database for severity

Every month we try and update this database with for severity 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 severity

Every month we try and update this database with for severity 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 severity 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.