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The case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the office of the Oncology Control Center Foundation (FCECON), using Samsung® gear VR virtual reality glasses and Samsung® smart watch.

The active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound in the office of the Oncology Control Center Foundation (FCECON), using a Samsung® smart watch.

The passive control group will perform meditation breathing exercises based on instructions and through an audio played from the health professional for 4 minutes in the office of the Oncology Control Center Foundation (FCECON), using a Samsung® smart watch.

Meditation will be taught through a video played on a Samsung® gear VR virtual reality glasses with monitoring of the patient's vital signs by the Samsung® smart watch to promote better quality of life and control cancer pain in patients treated at the Pain Therapy and Palliative Care Service.

Case group

Meditation will be taught through a video played on a Samsung® cell phone with monitoring of the patient's vital signs by the Samsung® smart watch to promote better quality of life and control cancer pain in patients treated at the Pain Therapy and Palliative Care Service.

Active control group

Meditation will be taught through a audio played on a Samsung® cell phone with monitoring of the patient's vital signs by the Samsung® smart watch to promote better quality of life and control cancer pain in patients treated at the Pain Therapy and Palliative Care Service.

Passive control group

Emily S Montarroyos

Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients.

This is a prospective, experimental, longitudinal study of the randomized controlled trial (RCT) type, carried out in three stages. Randomization will be carried out entirely using a specific application called Randomizer ® for Clinical Trial Lite. The defined sample was 39 participants per group. This would mean a total of 117 participants, divided into 3 groups of 39 participants each. Furthermore, considering the possibility of loss to follow-up, 12% was added to the final figure of 39 participants, due to the possibility of loss to follow-up, giving a final sample of 129 participants, divided into 3 groups: Experimental group; Passive control group and Active control group, with 43 participants in each group. At moment 1 (M1) all the patients will answer the sociodemographic and clinical questionnaire, and the other Quality of Life, Psychological Morbidity, pain scale and symptom scale instruments, after which they will perform the meditation used in the group to which they were randomly assigned, in the experimental case group (Group A) a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in a comfortable chair in the office of the Oncology Control Center Foundation (FCECON), using Samsung® gear virtual reality (VR) glasses and Samsung® smartwatch; in the active control group (Group B) a 7-minute video of mindfulness meditation on a cell phone with image and sound in a comfortable chair in the office of the Oncology Control Center Foundation (FCECON), using Samsung® smart watch; and in the passive control group (Group C) breathing exercises based on instructions from the health professional for 4 minutes in a comfortable chair in the office of the Oncology Control Center Foundation (FCECON), using Samsung® smart watch. After watching the video, all patients will answer the 4 Quality of Life, Psychological Morbidity, pain scale and symptom scale instruments and will receive instructions on how to perform the meditation, using a free app that offers mindfulness meditation videos for offline use with images and sound for 3 minutes three times for 4 weeks in a home environment. They will receive Short Message Service (SMS) alerts on their cell phones to remind them to do the video-guided home meditation on Mondays, Wednesdays and Fridays between 9am and 10am. A printed form will be given to each patient with the dates of the meditation to mark their satisfaction with the meditation by classifying it as totally dissatisfied - I hated it, dissatisfied - I didn't like it, indifferent, satisfied - I liked it or totally satisfied - I loved it. All the previous steps will be repeated in Moment 2 (M2), 4 weeks after Moment 1 (about 1 month), and in Moment 3 (M3): 8 weeks after Moment 1 (about 2 months). All patients, regardless of group, will be taught by different means to practice guided meditation regularly and will use the Samsung Smart watch Galaxy Watch6 LTE 44mm Super Active Matrix Organic Light Emitting Diode (AMOLED) Screen 1.47, Graphite, exclusively during the interview and meditation, handled by the researcher, at the Pain Therapy and Palliative Care Service of the Oncology Control Center Foundation (FCECON), at the three moments of the research. This watch has the following devices and capabilities: "BioActive Sensor - Optical Heartbeat, Electrocardiogram and Bioelectrical Impedance Analysis, in addition to the customizable heart rate zone, the Oximeter, Fall Detection and Emergency Call, and sleep quality monitoring". And it will be used to track quantitative variables: heart rate and blood oxygen saturation. It will also allow the patient to be monitored using the Brazilian version of the Distress Thermometer and Problem List from the National Comprehensive Cancer Network (NCCN), which is a free resource that identifies and addresses unpleasant experiences that can make it more difficult to deal with cancer, its symptoms or treatment. Finally, it will also be possible to use the smart watch to answer the visual pain scale for audio feedback. All participants will use their own Android cell phone with the functions installed for the use of the smartwatch and it will capture body movement data by acceleration signals, location with anonymized global positioning system (GPS) data, encrypted speech. The mobile questionnaire app, the visual pain scale and the Brazilian version of the Distress Thermometer and Problem List from the National Comprehensive Cancer Network (NCCN) - will be installed.

This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages.

Randomization will be carried out using a specific application called Randomizer ® for Clinical Trial Lite, which is a secure and validated application that works with encrypted network traffic using Transport Layer Security (TLS), a strong encryption. There will be 3 groups which will be divided into the Case Group, the Active Control Group and the Passive Control Group. Each patient will be seen individually wearing a Samsung® smartwatch and will not know about the other patients' meditation. The case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the Oncology Control Center Foundation (FCECON) office, using Samsung® gear VR virtual reality glasses. The active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound at the office. The passive control group will perform breathing exercises based on the healthcare professional's instructions for 4 minutes in the office.

Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service

Study With Cancer Patients at the CECON Foundation's Pain Therapy and Palliative Care Service: Meditation With Immersive Virtual Reality for Pain Relief

It has a body schema, in which the patient can mark the location of the pain, as well as 8 questions relating to pain intensity, on a scale of 0 to 10, the higher the score on the inventory, the worse the pain intensity.

Made up of 16 items, divided into domains: physical well-being, psychological well-being, existential well-being, support and physical symptoms. It has a single-item scale that measures overall quality of life, which is not included in the score, but is used to compare scores. It also has an open question for the patient to name the things that have had the greatest effect on their quality of life. The scale has eleven points from 0 to 10, and the higher the final score, the better the quality of life.

A 14-item instrument with two sub-scales, anxiety and depression, with seven items each to assess depression and anxiety. The score for each item can vary from zero to three, with a maximum score of 21 points for each sub-scale (anxiety and depression). Patients with no anxiety/depression are considered to score from 0 to 8, and ≥ 9 have anxiety/depression.

The ESAS is a simple, self-reported questionnaire designed to indicate objective and subjective symptoms. On this scale, the patient or their caregiver/family member assigns a score from 0 to 10 for each symptom, with 0 being the absence and 10 the greatest intensity of the symptom.

The National Comprehensive Cancer Network® (NCCN) Distress Thermometer will be applied as a questionnaire during the 3 moments. It is a translated and validated NCCN tool used to measure the "temperature" of the mental health of people with cancer. The Brazilian version of the NCCN Distress Thermometer and Problem List.

AC Camargo Cancer Center

Emily Santos Montarroyos

physician

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Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.

Case group includes patients with druggable ctDNA abnormality.

Control group

Druggable ctDNA alterations-guided therapy

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.

This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.

Peripheral blood lymphocytes (PBL) and plasma

Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer

Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer

The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.

The survival time between the beginning of treatment to death or the progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service	NCT06328751	Cancer Pain Quality of Life Palliative Medi...	Case group Active control ... Passive control...	18 Years - 75 Years	FUNDAÇÃO CENTRO DE CONTROLE DE ONCOLOGIA DO ESTADO DO AMAZONAS
Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer	NCT05427617	Metastatic Brea... Circulating Tum... Gene Abnormalit...	Control group Case group	18 Years - 70 Years	Hunan Cancer Hospital

Spots Global Cancer Trial Database for case group

Every month we try and update this database with for case group 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 case group

Every month we try and update this database with for case group 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 case group 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.