Behaviors and Mental Disorders

All Conditions

Nervous System Diseases

Neoplasms

Rare Diseases

Depression

Depressive Disorder

Brain Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Diseases

Quality of Life

Neuroepithelioma

no treatment

Karin Piil, PhD

This study builds on the limited body of existing literature combined with the results from the investigators' previous research conducted with 30 newly diagnosed patients with high-grade glioma (HGG) and 33 of their caregivers. This research established an overview of the daily life experiences when diagnosed with a HGG or being a caregiver. Descriptions of needs and preferences from time of diagnosis to one year exist. However, such data are still lacking the representation from long-term survivors (LTS) and their caregivers.

This mixed methods study aims to address perspectives on daily life experiences of long-term survivors with HGG and their caregivers as well as the needs and preferences for support, rehabilitation and palliation.

Separate telephone interviews with patients and their caregivers and self-reported questionnaires for patients will be conducted. The mixed methods design is a convergent sequential design using an identical sampling.

The dominant status relies on the qualitative data as the interviews are emphasized as the best suited method to address the primary aim of this study. The interviews follow a semi-structured interview guide for patients and for caregivers.

Information about socio-economic conditions, disease and treatment variables will be obtained by the investigator at baseline. Disease, treatment and clinical variables will be collected including the World Health Organization (WHO) performance scale (PS) which will be obtained by medical chart review. The self-reported questionnaires (quantitative data) are viewed as a useful supplemental data source, and embrace the topics as distress, anxiety and depressive symptoms.

Theoretical Framework The qualitative and quantitative research components represent different paradigmatic traditions including diverse ontological, epistemological and methodological assumptions. However, these paradigms are not necessarily incompatible. This study applied a pragmatic paradigm, reflecting a pluralistic view using both inductive and deductive reasoning. Applying a qualitative perspective, the present interviews seek to capture the subjective experiences of the study participants related to their life situation.

Analysis The semi-structured interviews will be recorded and transcribed in full length by the interviewer. Interview data will be transferred to NVivo 10 (qualitative data analysis computer software package) software program. A thematic analysis will be conducted for the analysis of the semi-structured interviews. Thematic analysis is a basic method for qualitative analysis as it identifies, analyzes and reports themes and patterns within data. The findings will be presented in themes and subthemes. A theme is an expression or context being defined as important by the researchers. In this study a theme is not necessarily dependent on quantifiable measures, but rather captures an important meaning in relation to the research questions and aims. Data from the interviews are descriptive in nature and reflect the subjective experience of the life situation of patients with HGG and their caregivers. The steps for thematic analysis are inspired by Braun and Clarke and as follows; Step 1) Data are transcribed immediately after an interview by the investigator or a research assistant. Transcriptions are read several times until the investigators are familiar with the depth and extent of the content. This process guides the investigators to the next level of analysis. Step 2) The text is read and divided into units of meanings, which are identified by the investigators. Some meaning units are sentences, others a whole paragraph. In this process data are coded in order to organize them into meaningful groups. This process assures that the whole dataset is systematically worked through by the investigators. Step 3) Then, the codes are analyzed in order to consider if different codes can be combined into mutual themes. This three step process will result in a collection of themes and sub-themes.

Statistical analysis The PS, the The Hospital Anxiety and Depression Scale (HADS) sub-scales, the The Functional Assessment of Cancer Therapy, General and brain cancer (FACT-G and FACT-Br) sub-scales and the responses to the ordinal items of the leisure time physical activity scale will be analysed separately. Socio-economic information and data from questionnaires will be entered into a database. The questionnaires will be analyzed according to their manuals. Categorical variables will be reported as frequencies and percentages, while continuous variables are reported as mean and standard deviations (s.d.) using a significance level of p\\0.05. HADS and FACT-Br data refer to the normative values. The statistical analysis will be performed with SAS (Statistical Analysis System) statistical software, version 9.3.

Long Term Survivors of High-grade Glioma and Their Caregivers

Long-term Survivors of High-grade Glioma

The results from the thematic analysis of the interviews will be discussed with other researchers

Interviews seek to explore the perspectives on the life situation and quality of life Analysis of the interviews identified three main themes, shared by all the patients : (1) Searching for meaningful activities. (2) Selecting information that enhances self-management strategies. (3) Protection for safety reasons.

The questionnaire is divided into two sub-scales for anxiety and depression with seven questions each all; 14 questions are rated on a four-point scale representing the degree of distress \[0 = none, 4 = unbearable\]. The responses from HADS are presented as mean scores for anxiety and depression.

Higher scores indicating worse outcome for depression (range 0.00-16.00) and anxiety (range 0.00-16.00).

The Performance Scale covers a rating from 0 to 5; 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5= Dead

FACT-Br total score range 84.00-195.67 The FACT-G total score provides a summary of the overall HRQOL \[range 0-108\]. The higher the score, the better HRQOL.

0=fully active; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry but any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, 4=bedbound, completely disabled

Novo Nordisk A/S

Rigshospitalet, Denmark

Principal Investigator

adverse events were not monitored/assessed

single-group study- long term survivors

no treatment: no treatment

HGG Patients

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

HGG patients diagnosed for more than 3 years ago

Karin Piil

single-group study- long term survivors

no treatment: no treatment Analysis of the interviews identified three main themes, shared by patients and their caregivers: (1) Searching for meaningful activities. (2) Selecting information that enhances self-management strategies. (3) Protection for safety reasons.

The dataset was analysed according to the steps described by Braun and Clarke in "Using Thematic analysis in psychology".

Number of Participants Identifying With the Three Main Themes Identified

anxiety

depression

The Hospital Anxiety and Depression Scale (HADS)

The WHO Performance Scale

FACT-G

FACT-Br

The Functional Assessment of Cancer Therapy, General (FACT-G)

Leisure time I

Leisure time II

Leisure time III

Leisure time IV

single-group study- long term survivors

no treatment: no treatment

Concerning depression, HADS showed moderate depressive symptoms in one patient (10%), and none of the patients reported having severe symptoms. Our data seem to be lower for anxiety (5.5±5.17) compared with the normative value (of 6.14±3.76), and higher for depression (4.15±4.0) compared with the normative value (of 3.68±3.07).

Questionnaire on Leisure Time Physical Activity Level

Overall Study

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Anxiety Disorders

Fatigue

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

During the initial week of intervention, sessions will be mainly carried on horseback. We will use the movement of the horse: (i) to allow patient re-appropriating her body and find harmony; (ii) to initiate rehabilitation of movements (shoulder, neck, upper extremity, whole body), gesture and femininity. The goal is to reconstruct a harmonic body image both in the private and public sphere, through different techniques. A few walking sessions may be needed to reinforce some landmarks.

During the short stages the work will be mainly done by walking alongside the horse. These reinforcement periods act like a trampoline, necessary to have a new momentum providing the opportunity to take a step back from the everyday, to regenerate somehow. The reaction time is generally optimized considering the imprint done during the initial long stage. One of the main themes that come up during this period is fear (relapse, the future, not achieving the goals, pain, relationship issues, etc.).

Patients in the control group are followed by dedicated personnel of the Montpellier Institut du Sein. This personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

The horse is an excellent collaborator in situations of physical and mental disability, whether temporary or consolidated. It provides support to humans towards an impairment (anatomical or physiological), a disability, or a restriction of participation as defined by the WHO in 2001. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on their cognitive capacities, such as attention, memory, psychomotricity, emotions, perceptions, the sequencing of complex movements, or the experience of oneself and the functions of time. Overall, the strong demand from the sensitive, sensory and motor spheres promotes and interacts with the mechanisms linked to the execution of tasks in the cognitive domain (memory, attention, executive functions, speed of information processing, etc.) through the interactions of several neural networks.

Hippotherapy

Personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

Conventional therapy

Manuel Gaviria, MD, PhD

Breast cancer is the most common women's cancer and the third leading cause of death. Advances in prevention, detection and primary treatment have improved overall survival leading to its growing acceptance as a long-term disease. Following the announcement of breast cancer, but also after primary treatment, some symptoms appear directly compromising psychic and physical spheres. Hippotherapy is an emerging specialized rehabilitation approach performed through specially trained horses by accredited health professionals. The proposed hippotherapy program offers key elements for physical, psychic and social reinforcement, complementing conventional care. The aim is to provide patients with tools to consolidate their self-awareness and thus strengthen their ability to cope with the disease.

Following the announcement and evolution of breast cancer, but also in response to primary treatment, some symptoms appear to directly compromise the psychic and/or physical sphere of the individual. Current rehabilitation programs are not sufficiently oriented to solve most of these symptoms. Hippotherapy is an emerging specialized rehabilitation approach, performed on a specially trained horse by accredited health professionals (e.g. medical doctors, physical therapists, occupational therapists, psychomotricians, speech-language pathologists, clinical psychologists). The horse is an excellent collaborator in situations of physical and psychic disability, whether temporary or consolidated. It provides human support for impairments (anatomical or physiological), activity limitations, and participation restrictions as defined by WHO. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on his cognitive abilities, i.e. attention, memory, psychomotricity, emotion, perception, sequencing of complex movements, self-experience, psychic temporality. Overall, the strong solicitation of the sensory and motor spheres promotes and interacts with the mechanisms related to the execution of tasks in the cognitive domain through the interactions of several neural networks. A randomized simple-blinded controlled trial on hippotherapy versus conventional care will be carried out. After giving their informed consent, patients will be enrolled in the trial. The 6-months program includes 1-week daily sessions of hippotherapy by the end of the initial cancer treatment followed by three short 2-days sessions with an interval of 2 months between each. The study will focus on 86 patients. Recruitment will be done over a 48-months' period. A battery of self-administered questionnaires will allow to study both the functional and psychological outcome. The primary end point will be quality of life, whereas body image, fatigue, anxiety, depression and cognitive performances will be the secondary end points.

A randomized simple-blind controlled trial on efficacy of the hippotherapy treatment against conventional one will be conducted. Patients selected will be randomly divided into 2 groups: hippotherapy treated group versus control group. To ensure that patients in the 2 groups are similar in all respects, except for the planned intervention, the randomization will be stratified by age representing respectively two stages: 1) Pre-menopause; 2) Post-menopause; and by type of treatment: A) Single treatment: surgery or chemotherapy or hormone therapy or radiotherapy; B) Two or more treatments.

Data will be collected on the Montpellier Institut du Sein site by relying on the CRA who will follow up and check the information in due time of the self-questionnaires. The data will be duly anonymized and handled blindly. Data will be centralized on a secure server at the Equiphoria Institute. Their processing and analysis will be carried out blindly by the PI or by a private service provider (Biostatem France)

Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer

Effect of Multidisciplinary Management by Hippotherapy on the Quality of Life of Women With a Diagnosis of Breast Cancer: Randomized Controlled Clinical Trial on the Effectiveness of the Therapeutic Intervention

Dissemination of study results will be done through a classic strategy for publications (reports, scientific publications) and communications (congresses, meetings). The coordinator will be in charge of the dissemination strategy. Controlled access to the final trial dataset will be given when a reasonable request has a precise and valid scientific aim. Thus, we will protect the rights of patients and the intellectual property of the scientists who designed the trial and collected the data.

This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores ranges from 0 to 100, a higher score represents a higher ("better") level of functioning.

The questionnaire focuses on patients' emotional and behavioral experiences of their body image, resulting from cancer and treatment, including aspects of perceived physical appearance, body integrity, and seduction capacity. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.

MFI seems to be one of the best questionnaires to provide a fatigue profile. Its psychometric properties have been studied in different populations and it is easy to administer. Score ranges from 0 to 100. Higher total scores correspond with more acute levels of fatigue.

This scale was constructed excluding any item concerning somatic aspects, aspects that could be confused between physical and mental illness. It is a self-questionnaire to be completed according to oneself condition during the past week. Score ranges from 0 to 21 for each item. Higher total scores correspond to presence of the respective state.

The questions are grouped into six cognitive domains (memory, verbal fluency, concentration, mental sharpness, resistance to interference, multitasking ability) and two sub-criteria (visibility of the disorder by the entourage, impact on the quality of life). 37-item ranging from 0 to 4 consist of four subscales. Higher scores represent better functioning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long Term Survivors of High-grade Glioma and Their Caregivers	NCT02965144	Quality of Life Brain Diseases Depression Physical Impair...	no treatment	18 Years -	Rigshospitalet, Denmark
Long Term Survivors of High-grade Glioma and Their Caregivers	NCT02965144	Quality of Life Brain Diseases Depression Physical Impair...	no treatment	18 Years -	Rigshospitalet, Denmark
Long Term Survivors of High-grade Glioma and Their Caregivers	NCT02965144	Quality of Life Brain Diseases Depression Physical Impair...	no treatment	18 Years -	Rigshospitalet, Denmark
Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer	NCT04350398	Breast Cancer F... Side Effects Psychological D... Physical Disabi...	Hippotherapy Conventional th...	18 Years - 80 Years	Alliance Equiphoria

Spots Global Cancer Trial Database for physical impairment