Behaviors and Mental Disorders

All Conditions

Quality of Life

Integrated Short-term Palliative Rehabilitation + usual care

Participants will be offered up to 3 manualised sessions (face to face and/or remotely, via telephone or video-conference) delivered by an expert rehabilitation practitioner (physiotherapist, occupational therapist,).

Core components focus on (i) self-management of symptoms, (ii) physical activities and fitness, and (iii) social participation. Delivery of rehabilitation intervention components will include explicit use of behaviour change techniques including goal setting and action planning to focus on outcomes that are meaningful for the person, their family, and clinicians.

Integrated Short-term Palliative Rehabilitation

INSPIRE Research Team

Inna Chen

Guillaume Economos

Augusto Caraceni

Stefania Costi

Line Oldervoll

Barry Laird

Rachel Byrne

Gareth Jones

Nicola Peat

Matthew Maddocks

Kirsty Bracewell

Lucy Fettes

The goal of this intervention trial is to determine if palliative rehabilitation in addition to usual care is more effective than usual care at improving health-related quality of life in patients with incurable solid cancer.

Background and study aims Cancer is one of the main causes of illness, burden and death in Europe. The Joint Research Centre (JRC) of the EU estimated 2.7 million new cancer cases. For all cancers, between 53-79% of men and 41-62% of women are diagnosed with incurable disease. Their cancer treatment is life-prolonging but will not cure the disease.

Cancer is also a major and growing contributor to disability (loss of function). Recent global estimates suggest a loss of 382 disability-adjusted life years per 1000 individuals. Disability is a poorly recognised and undertreated consequence of incurable cancer. Over time, loss of function results in people not being able to continue with valued roles and routines, to manage usual household and social activities, and to self-care. One-third of adults with cancer require assistance to perform basic activities like washing and dressing, and half need help with extended activities like shopping and transportation. Disability reduces quality of life and well-being. Disability related to daily activity is closely related to unplanned hospital admissions and mortality.

Palliative rehabilitation empowers people with incurable conditions to actively manage their condition themselves, enabling them to live fully and enjoy the best health-related quality of life possible, including cancer towards the end of life. It aims to reduce symptoms and help people to stay independent and socially active. WHO policy on Universal Health Coverage states both rehabilitation and palliative care as essential, quality health services. It recommends they be integrated within and between primary, secondary, and tertiary health systems using a multi-professional workforce. While integrated rehabilitation has been achieved for people with chronic respiratory, cardiac and stroke conditions, this is not the case for people with cancer, especially those living with incurable disease. Access to palliative care services has increased but access to rehabilitation remains varied.

In this study, the investigators are evaluating a rehabilitation intervention that has been designed to meet the needs of people living with advanced cancer. The study is taking place in countries across Europe, and the investigators plan to recruit 340 participants from hospitals. The investigators aim to find out if and how the rehabilitation intervention affects the participants who take part in the study. The investigators will also study how it fits in with current healthcare services.

Who can participate? This study is suitable for patients aged 18 or over, diagnosed with advanced solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments.

What does the study involve? After signing the informed consent, the participation in this trial will last 16 weeks. Participation in this trial is voluntary and the participants can withdraw any time.

During the first face to face visit, participants will be randomly allocated to receive either INSPIRE rehabilitation intervention + usual care or usual care only. The random allocation will be done using a software maintained by the King's Clinical Trials Unit.

The trial schedule depends on group allocation:

Participants allocated to usual care only will be asked to complete questionnaires at weeks 4, 8 and 16 either on their own, with a help of a friend or family member, or with the researcher over the telephone or in person. It should take 30 - 45 minutes to compete all the questions.

Participants allocated to the INSPIRE rehabilitation + usual care will be offered up to 3 rehabilitation visits in addition to the questionnaire completion at weeks 4, 8 and 16. Each visit will last 30 -90 minutes.

1. st rehabilitation visit will be face to face and will be scheduled no later than 14 days after joining the trial. During this visit, a rehabilitation action plan will be put together.
2. nd rehabilitation will be scheduled around 4 weeks, but no later than 5 weeks after joining the trial.
3. rd rehabilitation visit will be scheduled around 6 weeks, but no later than 7 weeks after joining the trial.

Both visits 2 and 3 can be face to face, via telephone or via video call and participants will have the opportunity to review and, if needed, change their rehabilitation action plan.

There won't be any changes in usual care for participants that have been allocated to the rehabilitation intervention group.

Participants allocated to the INSPIRE rehabilitation intervention may also be invited to an optional one-to-one interview with a member of a research team. The interview will last around 30-60 minutes. At the week 28 the research team will look at the participants medical notes to see how they're getting on; however participants will not need to do anything at this time.

The trial team will collect participants' medical history and demographic data; however demographic data will be anonymised and only year of birth and initials will be shared with the research teams. All data will be stored on a password-protected database to which only authorised individuals will have access.

What are the possible benefits and risks of participating? The study is designed to help us understand if the rehabilitation intervention can benefit people living with advanced cancer. This is a very low risk study. This study will require attending appointments and complete questionnaires which might be tiring for some people. It is not yet clear if taking part in this study will be directly beneficial for the study participants. however, taking part should help to improve future care and research, to help care for people with similar conditions in the future.

Where is the study run from? INSPIRE is coordinated by King's College London (UK) with centres in the UK, Italy, Denmark, Norway, and France.

When is the study starting and how long is it expected to run for? September 2022 to August 2026

Who is funding the study? Funding to conduct the trial in the European Union is provided by HORIZON-HLTH-2021-DISEASE-04. In the UK this study is funded by UKRI Innovate (UKRI Reference Number: 10047799)

Who is the main contact? INSPIRE Trial Manager: INSPIRE@kcl.ac.uk

Multinational, parallel group, randomised, controlled, assessor blind, superiority trial

Owing to the nature of the intervention, it is not possible to blind participants or intervention practitioners. Individual participants are allocated on a 1:1 basis to receive either palliative rehabilitation plus usual care or usual care. Treatment allocation will not be disclosed to the CTRU KCTU trial team or to other members of the research teams involved in data analysis to maintain blinding during outcome assessment and to minimise possible bias. Individual participants are allocated on a 1:1 basis to receive either palliative rehabilitation plus usual care or usual care. A computer-generated minimisation programme that incorporates a random element will be used to ensure that treatment groups are well balanced for: trial country ,baseline FACT-G score (\<=64, 65-79, 80+), ECOG performance status (2, 3) in order to guard against chance bias in patient allocation for prognostic factors.

Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

Integrated Short-term Palliative Rehabilitation to Improve Quality of Life and Equitable Care Access in Incurable Cancer: A Multi-national Randomised Controlled Trial

Acceptability of Intervention Measure (AIM) is a 4-item scale that measures the perception of satisfaction and agreeability of an intervention. Items are rated using a Likert-type semantic differential scale, ranging from 1 to 5. The AIM has a Cronbach's alpha of 0.85

The Intervention Appropriateness Measure (IAM), a 4-item scale measuring the perceived relevance and compatibility of the intervention. Items are rated using a Likert-type semantic differential scale, ranging from 1 to 5. The IAM has a Cronbach's alpha of 0.91

Qualitative interviews will be conducted to assess the acceptability and the appropriateness of the intervention from the patients' point of view. These will allow patients to offer their opinion and feelings about the intervention, to identify convergences and divergences between the quantitative and qualitative parts, and finally to deepen our implementation evaluation of the acceptability and appropriateness aspects.

A bespoke quantitative questionnaire was designed using adapted items from our literature review of published implementation questionnaires (https://implementationoutcomerepository.org/), rated based on a semantic differential scale (Likert-type), to fit with the ratings used for AIM and IAM

Assessed using Functional Assessment of Cancer Therapy (FACT-G) General scale, where high score indicates better functional well-being and quality of life for cancer patients. Lower scores may indicate a greater burden of symptoms, reduced ability to perform daily activities, and overall lower satisfaction with life during the cancer journey.

Functional Assessment of Cancer Therapy (FACT) General scale at 4 and 16 weeks, where high score indicates better functional well-being and quality of life for cancer patients. Lower scores may indicate a greater burden of symptoms, reduced ability to perform daily activities, and overall lower satisfaction with life during the cancer journey.

Higher scores reflect more significant disability, while lower scores indicate better functional status and less disability. It is used to measure and assess the impact of health conditions or disabilities on a participant's ability to function in their daily life.

Symptoms- Palliative Outcomes Scale - Symptoms (POS-S): designed to evaluate the severity and impact of various symptoms on the participant's quality of life. Higher scores indicate more severe symptoms and a greater impact on the patient's well-being, while lower scores indicate milder symptoms and less disruption in daily life.

Goal attainment- Goal attainment scale (GAS-Light): is a tool used to measure the extent to which an participant has achieved specific goals or objectives.

Client Service Receipt Inventory at 8 and 16 weeks

Hospices Civils de Lyon

University of Bergen

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Research Unit for General Practice, Aarhus University

University of Edinburgh

EAPC

Azienda USL - IRCCS di Reggio Emilia

King's College London

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Subjects will be referred to specialists and/or supportive care interventions based on issues/deficits identified on a baseline geriatric assessment. These interventions will be selected based on deficits or problems identified on baseline assessments. These include referral to physical/occupational therapy for those with physical deficits (Activities of Daily Living impairment, Instrumental Activities of Daily Living impairment, Timed Up and Go, or falls), to optometry/ophthalmology (for visual impairment), to audiology (for hearing impairment), to pharmacist (for polypharmacy), and to cancer center support program (for Mental Health Index 13 criteria).

Supportive care interventions

Christopher E Jensen, MD

Myeloma is the second most common type of blood cancer in the United States. Myeloma most commonly affects older adults. While some younger individuals do get myeloma, the average age when people are first diagnosed with myeloma is around 69 to 70.

Along with having a higher risk for myeloma, older adults have an increased chance of developing other health problems or issues. However, not everyone ages in the same way. Some older adults experience major changes in health or degree of independence at relatively younger ages, while others remain quite healthy for many years. The specific issues that develop with age can also vary from person to person. One older adult may face difficulties with vision or hearing, while another may develop memory problems.

Historically, cancer doctors have not done a very good job identifying these non-cancer issues. As a result, research has focused on better ways to systematically pick up on issues that may impact cancer outcomes or quality of life. The outgrowth of this research is assessments and questionnaires referred to as "comprehensive geriatric assessments," which evaluate the health and functionality of older adults thoroughly but efficiently. In both myeloma and other types of cancer, problems identified through geriatric assessments have been shown to predict how likely people are to develop side effects of cancer treatment and predict how long people are likely to live with cancer.

Prior research has not addressed how best to help with the issues picked up through a geriatric assessment among patients undergoing treatment for myeloma, although a number of effective interventions have been shown to benefit older adults with similar problems in other settings. Therefore, the current study will test a strategy of systematically screening older adults undergoing myeloma treatment for geriatric-assessment-related deficits and referring participants to appropriate services and resources. The geriatric assessment in this study includes tests of mobility, memory, vision, hearing, and nutrition as well as questions about symptoms and social support. Individuals who have deficits in one of these areas will be referred to relevant services and resources such as physical therapy, a pharmacist, or the cancer center support program. They will then repeat the same assessment three months later, and the results will be compared to their original assessment to see if the deficit has improved, with particular attention to mobility and social support.

STUDY OUTLINE

Study participants complete a baseline Geriatric Assessment and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ) Core 30 (C30) and Myeloma supplement (MY20) questionnaires, either at the time of enrollment or as part of previous research studies.

Based on these assessments, an intervention strategy is developed by Study Team. These interventions largely consist of referrals to relevant specialists and existing services. These recommendations are communicated to the study participant, and participant-approved intervention referrals are made.

Following an initial appointment with these specialists, further follow-up will be determined based on the subject and specialist without input from the Study Team.

At three months from enrollment, study participants will be asked to complete a follow-up geriatric assessment, repeat EORTC questionnaires, and a satisfaction /feedback survey.

Duration of Therapy:

For patients referred to specialists as above, the duration of treatment or care with the specialist will be determined based on an agreement between the specialist and study participant.

Duration of Follow-up:

As part of this study, participants will only be followed through the three-month follow-up assessment described above. For subjects participating in or recruited from other research studies, follow-up according to those other protocols will continue.

Single-arm pilot study of supportive care interventions

Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma

Geriatric-assessment-guided Interventions to Address Functional Deficits in Older Adults Undergoing Treatment for Multiple Myeloma

Preliminary efficacy with respect to physical function will be evaluated via changes in EORTC Quality of Life of Cancer Patients (C30) questionnaire physical function scores. The change in mean score from baseline to 3 month follow up among study participants will be reported.

Preliminary efficacy with respect to psychosocial function will be evaluated via changes in PROMIS Social Isolation score (evaluated using Social Health v2.0 instruments- Social Isolation 4a). The change in mean score from baseline to 3 month follow up among study participants will be reported.

Attendance at at least one appointment for a specialty / supportive care resource to which the subject is referred. This will be reported as the percentage of participants who attend at least one such appointment.

Subject satisfaction with the intervention program, which will be assessed by a single-item 5-point Likert scale response, with higher scores indicating greater satisfaction. The mean score reported by study participants will be reported.

Conquer Cancer Foundation

UNC Lineberger Comprehensive Cancer Center

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Chronic Pain

Neuralgia

Pain

Breast Diseases

Skin Diseases

Neurologic Manifestations

Peripheral Nervous System Diseases

Neuromuscular Diseases

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) program following medical treatment optimization. The MBSR program will be composed of eight weekly 2.5 hour sessions and one 6 hour session midway through the course.

Participants assigned to this group after medical treatment optimization will act as wait-list controls for the MBSR group. They will be enrolled in the MBSR workshop 3 months after the corresponding intervention group completes the program.

Consists of eight weekly 2.5 hour sessions and one 6 hour session midway through the course. All sessions will be conducted by a psychologist or social worker with experience in chronic pain, formal MBSR training and 5 years of experience leading MBSR groups. To assess therapist adherence to the protocol, sessions will be recorded. A random selection of 50% of sessions will be rated by an MBSR trainer who completed the University of Massachusetts Centre for Mindfulness in Medicine, Health Care and Society Teacher Development Intensive using a checklist of specified treatment components. A percentage score for each session rated will be calculated to determine therapist adherence.

Mindfulness-Based Stress Reduction

Patricia Poulin, PhD

Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.

The investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in MBSR.

The primary outcome is pain interference. The investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the Brief Pain Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain Inventory Interference score) in the interdisciplinary program in comparison to medical treatment alone.

The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain

The Effect of an Inter-Disciplinary Program, Including Mindfulness-Based Stress Reduction, on Psychosocial Function, Pain Perception, Disability and Quality of Life in Breast Cancer Survivors With Chronic Neuropathic Pain

The primary outcome is pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale. The Brief Pain Inventory (BPI) - Pain Interference consists of 7 numerical scales (0 to 10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life.

Neuropathic pain intensity will be measured using the Neuropathic Pain Symptom Inventory (NPSI), a self-report questionnaire that consists of 10 pain descriptors and two temporal items. Responses are rated on a numerical scale (0-10) and a total intensity score is calculated. Five sub-scores are also derived: spontaneous burning pain, spontaneous pressing pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia.

Pain Severity will be measured using the Brief Pain Inventory (BPI) - Pain Severity. The BPI consists of 4 numerical scales (0 to 10) rating pain severity at its worst, at its least, on average, and at the time of filling out the measure. Each severity question is analyzed individually.

The Profile of Mood States (POMS-2A) will be used to measure mood disturbance. Participants are asked to rate 65 adjectives using a 5-point likert scale ( 0= not at all, to 4 = extremely) based on how they have been feeling during the past week, including the day they are filling out the questionnaire. A total mood disturbance score is calculated, as well as scores for 6 subscales: depression, tension-anxiety, anger-hostility, vigor-activity, fatigue, confusion-bewilderment.

The participants' perceived degree of change in overall status will be measured using the Patient Global Impression of Change (PGIC) scale. The PGIC uses a 7-point likert scale (very much worse, to very much better) to measure how much the participant feels their overall status has changed since the start of the study.

The Perceived Stress Scale (PSS) will be used to measure the participants' perceived stress levels. The PSS uses a 5-point likert scale (0=Never, to 4=Very often) to measure the degree of stress a participant has experienced over the past month. A total perceived stress score is obtained by reversing the scores on items 4, 5, 7, and 8, and then summing across all 10 items. Higher scores indicate higher perceived stress.

The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item scale used to assess the severity of depressive symptoms over the past two weeks and is based on Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for major depression. Total scores range from 0 to 27, and clinical cut-points correspond to mild, moderate, moderately severe, and severe depression.

The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).

Mindfulness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.

Quality of life will be measured by the Short-Form-12 Health Survey (SF-12v.2). The SF-12v2 is a brief, twelve-item self-report measure based on the Short-Form-36. It includes items assessing eight health domains, such as bodily pain, social functioning, role limitations due to physical health, and general health perceptions. Two summary scores, the physical composite scale (PCS) and mental composite scale (MCS) are computed based on the 12 items. Scores range from 0 to 100, with higher scores indicating greater quality of life.

Cortisol is a useful biomarker of stress levels. One cm hair samples will allow us to collect data on cortisol exposure over the past month.

Six mL whole blood samples will be obtained from participants and the measurement of cytokine secretion and CRP will be performed. The concentrations of interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor - alpha (TNF-α), as well as C reactive protein (CRP) production will be quantified and recorded. All samples and standards will be analyzed in duplicate.

Total genomic DNA will be extracted from 0.2 mL of whole blood. The relative average Telomere Length (TL) will be determined and recorded. Samples will be analyzed in triplicate.

Changes in participants' neuronal health will be measured with MRI sessions that include diffusion tensor imaging (DTI). These imaging sessions will provide measures of white matter integrity (fractional anisotropy, mean diffusivity, radial diffusivity).

Changes in blood flow to areas of participants' brains known to be associated with emotional regulation will be measured using functional magnetic imaging (fMRI).

High resolution magnetic resonance imaging will be used to look at the anatomy of participants' brains and measure changes in structural volume.

Canadian Breast Cancer Foundation

Canadian Institutes of Health Research (CIHR)

Ottawa Hospital Research Institute

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Sclerosis

Neoplasm Metastasis

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Neoplastic Processes

Chronic Disease

Disease Attributes

Antipyretics

Analgesics

Antineoplastic Agents

Antirheumatic Agents

Hematinics

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Anti-Infective Agents

Anti-Allergic Agents

Dermatologic Agents

Acetaminophen

Rituximab

Prednisolone

Liver Extracts

Methylprednisolone

Carbamide Peroxide

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glatiramer Acetate

(T,G)-A-L

Chlorpheniramine

Antineoplastic Agents, Immunological

Immunologic Factors

Adjuvants, Immunologic

Immunosuppressive Agents

Patients in this group will receive 1g of rituximab in 500 cc normal saline serum through intravenous infusion as one treatment course. The treatment course will be repeated in 6 months. Along with rituximab, 100 mg methylprednisolone, 10 mg chlorpheniramine, and 500 mg acetaminophen will also be injected to decrease side effects of rituximab.

Patients in this group will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection.

Patients will receive 1 g of rituximab (two vials of Zytux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion as one treatment cycle. This cycle will be repeated every 6 months. Along with rituximab, patients will receive 100 mg of methylprednisolone, 10 mg of chlorpheniramine, and 500 mg of acetaminophen. Before each cycle, patients will be evaluated regarding complete blood count (CBC)-diff, blood urea nitrogen (BUN), Cr, and liver function tests.

Patients will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection. Patients will undergo electrocardiography before starting the treatment to find any abnormal finding. Also, lab tests will be checked for them prior to the treatment, including CBC-diff, BUN, Cr, and liver function tests.

Vahid Shaygannejad, M.D.

The purpose of this study is to compare expanded disability status scale, annualized relapse rate, Gad-enhanced brain lesions, and side effects after administration of rituximab and glatiramer acetate among patients with active secondary progressive multiple sclerosis during a one year follow up through a randomized clinical trial.

Multiple sclerosis (MS) is an autoimmune inflammatory demyelinative disease of central nervous system. Active secondary progressive MS means progressive accumulation of disability after an initial relapsing course which is also associated with clinical relapses and/or new/enlarged Gad-enhanced brain lesions. This form of the disease leads to high rates of morbidity and mortality among patients. Different immunosuppressive and immunomodulatory agents are recommended by researchers to decrease relapses and improve disability among MS patients. The effect of these medications on different phenotypes of MS are mostly investigated solely and very small number of comparative studies are conducted to evaluate the superiority of these medications on each other.

Glatiramer acetate is one of the known MS medications which is being used to control relapses from a long time ago and different clinical trials have shown its partial efficacy among MS patients. On the other hand, rituximab is one of the medications which is recently suggested for treatment of MS and currently phase II clinical trials are conducted to evaluate the efficacy of this medication among patients. As previously stated, there is a lack of clinical trials to compare the efficacy of suggested medications among secondary progressive patients. To fill this gap, we aimed to compare the efficacy of these two medications on disability, annualized relapse rate, and Gad-enhanced brain lesions among patients with active secondary progressive MS through a randomized clinical trial during a one-year follow-up period.

Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients

Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate

We may share the individual participant data (anonymously) on request of qualified investigators.

expanded disability status scale will be measured in the baseline and after 12 months of intervention. This scale measures the disability of patients with a score, ranging from 0 (normal neurological exam) to 10 (death due to MS). This score is assigned to the patient by the neurologist and after neurological examination. The patient will be given a score in this scale according to the observed disability. The scores will be compared at the end of study.

adverse drug reactions will be observed closely and reported during the intervention. We will compare the number of adverse drug reactions in two groups. Also, adverse drug reactions will be described by details in each group.

patients will undergo brain MRI before and after the study and number of Gad-enhanced brain lesions will compared before and after intervention.

annualized relapse rate will be measured in the baseline (according to patients' history in the last year) and after 12 months of intervention.

Isfahan University of Medical Sciences

Professor of Neurology

Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) course directly following medical treatment optimization. The MBSR course consists of eight weekly 2-hour sessions and one 6 hour session midway through the course and involves psychoeducation, relaxation techniques, gentle stretching (very mild form of yoga), and different forms of meditation. Participants will learn ways to better cope with their pain and the disability and distress related to it with a goal of reducing the stress response that is our body's normal reaction to pain. All sessions will be conducted by a psychologist or social worker with a minimum of 2 years of experience in chronic pain management, formal MBSR training and 2 years of experience leading MBSR groups.

Mindfulness-Based Stress Reduction (MBSR)

Patricia Poulin, Ph.D

This randomized controlled trial will evaluate the effectiveness of an interdisciplinary treatment approach combining medical management with an online Mindfulness-Based Stress Reduction (MBSR) program in reducing disability and improving quality of life among cancer survivors living with moderate to severe chronic neuropathic pain.

Chronic neuropathic pain (CNP) affects close to 50% of cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. In our recent survey with cancer survivors, we found that the capacity to be aware of different aspects of one's day-to-day experiences, without judgment or reactivity (i.e., being mindful) predicted decreased pain intensity, pain related disability, and increased health-related quality of life among cancer survivors with CNP. Building on these findings, the present randomized controlled trial will evaluate the effectiveness of an online Mindfulness-Based Stress Reduction (MBSR) program for cancer survivors with moderate to severe CNP. The program will benefit patients in rural and remote regions and patients with mobility issues.

We will recruit 100 cancer survivors. All will have their medical treatment optimized by a pain specialist. Additionally, they will complete an 8-week online MBSR program. We hypothesize that the online MBSR program will result in less pain perception, better function and increased health-related quality of life. We will also examine the effects of the MBSR training on biomarkers of stress and immune function.

Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain

The Effects of an Online Mindfulness-Based Stress Reduction (MBSR) Program on Quality of Life and Immune Function Among Cancer Survivors With Chronic Neuropathic Pain

The Profile of Mood States (POMS-2A) will be used to measure mood disturbance. Participants are asked to rate 65 adjectives using a 5-point likert scale ( 0= not at all, to 4 = extremely) based on how they have been feeling during the past week, including the day they are filling out the questionnaire. A total mood disturbance score is calculated, as well as scores for 6 sub-scales: depression, tension-anxiety, anger-hostility, vigor-activity, fatigue, confusion-bewilderment.

Quality of life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G). The FACT-G is a 27-item instrument containing general statements which fall within four domains of quality of life: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Participants are asked to respond to each statement using a 5-point Likert scale from 0 (not at all) to 4 (very much) to indicate how true the statement is for them over the previous seven days.

Fatigue will be measured using the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument that measures fatigue severity and the impact it has had on participants' day-to-day functioning in the previous 24 hours. Participants are asked to rate their fatigue at the time of completion as well as their average fatigue and worst fatigue over the previous 24 hours on an 11-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine), and the degree to which their fatigue has interfered with their general activity, mood, walking ability, normal work, relations with others, and enjoyment of life over the previous 24 hours on an 11-point Likert scale from 0 (does not interfere) to 10 (completely interferes).

Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item instrument that measures seven factors of cancer recurrence: triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. Participants respond to questions using a 5-point Likert scale from 0 (not at all or never) to 4 (a great deal or all the time). The scale provides a global score as well as seven sub-scale scores; one for each factor. A higher score indicates higher levels of fear of cancer recurrence.

Immune function, with particular attention to the following parameters: tumor necrosis factor - alpha (TNF-α), interleukin-6 (IL-6), interleukin-4 (IL-4), interleukin-10 (IL-10), and c-reactive protein (CRP) will be measured from participant blood samples. Six mL whole blood samples will be obtained from participants and the concentration of these parameters will be quantified and recorded. All samples and standards will be analyzed in duplicate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrated Short-Term Palliative Rehabilitation in Incurable Cancer	NCT05984797	Cancer	Integrated Shor...	18 Years -	King's College London
Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma	NCT04999085	Multiple Myelom... Myeloma Disability Phys... Disabilities Mu...	Supportive care...	60 Years -	UNC Lineberger Comprehensive Cancer Center
The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain	NCT02125006	Breast Cancer Painful Neuropa... Chronic Pain Worries; Pain o... Quality of Life	Mindfulness-Bas...	18 Years -	Ottawa Hospital Research Institute
Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients	NCT03315923	Secondary Progr...	Rituximab Glatiramer Acet...	18 Years - 55 Years	Isfahan University of Medical Sciences
Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma	NCT04999085	Multiple Myelom... Myeloma Disability Phys... Disabilities Mu...	Supportive care...	60 Years -	UNC Lineberger Comprehensive Cancer Center
The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain	NCT02125006	Breast Cancer Painful Neuropa... Chronic Pain Worries; Pain o... Quality of Life	Mindfulness-Bas...	18 Years -	Ottawa Hospital Research Institute
Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain	NCT02758197	Cancer Painful Neuropa... Chronic Pain Worries; Pain o...	Mindfulness-Bas...	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for disability

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

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