Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphosarcoma

Acute Graft Versus Host Disease

Children and adolescents at the end of acute treatment for leukemia and non-Hodgkin lymphoma without any exercise intervention

Participants perform a test battery to assess the capability to accomplish Activities of Daily Living that includes a standardized and validated questionnaire, a parcour with tasks based on Activities of Daily Living and a motor performance test.

Assessment of the accomplishment regarding Activities of Daily Living at the end of acute treatment

Sabine Kesting

Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. This associated investigation to the study with the ClinicalTrials.gov Identifier NCT03934060 aims at collecting data in a comparison cohort with respect to ADLs in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.

ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma

Activities of Daily Living at the End of Acute Treatment for Acute Leukemia or Non-Hodgkin Lymphona During Childhood and Adolescence

The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions and the current status of accomplishment of activities of daily living. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer).

Motor performance is assessed by the MOON-test (Motor performance test in Pediatiric Oncology), a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children.

A standardized parkour with tasks imitating activities of daily living is used to objectively verify the ASK score. Points from 0-4 are counted for each task depending on quality of movement (0 = task can not be completed, 1 = task can be completed with help, 2 = task can be completed with several attempts, 3 = task can be completed with only little effort, 4 = task can be completed without any problems or effort). There are no reference values for the parkour, but intra-individual changes are analyzed.

Ludwig-Maximilians - University of Munich

Technical University of Munich

Principal Investigator

Mouth and Tooth Diseases

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Dental Caries

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

Patients with five or more brain metastasis assigned by randomization to Stereotactic RadioSurgery (SRS) or Stereotactic Body RadioTherapy (SBRT) will be treated with a highly-conformal metastasis-directed single dose between 15 and 24 Gy or fractionated dose (e.g. 27 Gy in 3 fractions), respectively, depending on lesion size, while sparing clinically negative brain. The treatment will be delivered using five non-coplanar arcs and a mono-isocentric technique.

Patients with five or more brain metastasis assigned by randomization to Whole Brain Irradiation (WBI) will be treated using a 3D-Conformal RadioTherapy technique for a uniform dose delivery of 30 Gy in 10 daily/fractions to the target, that is entire brain.

To treat only brain metastasis identified through Magnetic Resonance imaging by means of stereotactic radiotherapy (experimental intervention) to determine if sparing of clinically uninvolved brain implies a better neurocognitive performance, quality of life and level of autonomy in activities of daily living respect to Whole Brain Irradiation (active comparator).

Stereotactic RadioTherapy

To irradiate the entire brain, site of at least 5 parenchymal metastasis.

Whole Brain Irradiation

Gianluca Ferini

Irene R. Cravagno, Chief Radiation Oncology Unit

Anna Viola, Radiation Oncologist

Gianluca Ferini, Chief Radiation Oncology Unit

Vito Valenti

Antonella Tripoli

Silvana Parisi

Stefano Pergolizzi

Antonio Pontoriero

Alberto Cacciola

Sara Lillo

Gianluca Mortellaro

Giuseppe Ferrera

This work aims to evaluate neurocognitive performance, daily activity and quality of life and local control among patients with brain metastasis (MBM) ≥ 5 due to solid tumors treated with Stereotactic RadioSurgery (SRS) or Whole Brain RadioTherapy (WBRT). This multicentric randomised controlled trial will be conducted at the Fondazione IOM (Viagrande) in collaboration with REM (Viagrande), Hospital G. Martino (Messina) and Hospital Civico ARNAS (Palermo). It will involve, within 5 years starting from 15 September 2020, the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy \> 3 months, histological confirmation of primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) of 20/30, Barthel Activities of Daily Living score 90/100, to be subjected to SRS on each brain lesion by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBRT (control arm). The primary endpoints are neurocognitive performance, quality of life and autonomy in daily-life activities variations, the first one assessed by Moca Score and Hopkins Verbal Learning Test - Revised, the second one through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL) and Brain Neoplasm (BN-20) questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatments frequency, acute and late toxicities, KPS decrease. It will be considered significant a statistical difference of at least 29% between the two arms (statistical power of 80% with a significance level of 95%). This trial has been approved by the local ethics committee on July 7th 2020 (record 70). Several studies debate what is the predominant factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiotherapy, especially if extended to the entire brain, or intracranial disease progression? Answer to this question may come from current opportunity, thanks to recent technological advancement, to treat, with significant time savings, improved patient comfort and at the same time minimizing the dose to healthy brain tissue, Multiple Brain Metastasis simultaneously, otherwise attackable only by panencephalic irradiation. The pursuit of a local control rate comparable to that obtainable with WBRT remains the fundamental prerequisite for the aforementioned related assessments.

WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)

WHOle Brain Irradiation and STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER): a Prospective Comparative Study of Neurocognitive Outcomes, Level of Autonomy in Daily Activities and Quality of Life

To assess how neurocognitive performance changes after SRS/SBRT compared to WBI

To assess how level of autonomy in activities of daily living changes after SRS/SBRT compared to WBI

To assess how quality of life changes after SRS/SBRT compared to WBI

Time between treatment and cerebral disease progression detected through Magnetic Resonance imaging

Time from the first day of treatment to exitus

Difference in needing further subsequent radiotherapy treatment between SRS/SBRT and WBI arms

Toxicities registered within three months from treatment

Toxicities registered after three months from treatment

Evaluation of how patient's performance status modifies after treatment

University of Messina

University of Palermo

Mediterranean Institute of Oncology

Fatigue

The control group received routine treatment and nursing care

Fatigue Self-management Programme

Zeynep Özer

The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.

This is a randomized controlled trial consisting of two groups: experimental and control.

The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients

The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients

The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.

The Katz Index of Independence is a validated, self reported instrument assessing average daily living activities.

Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being.

Akdeniz University

Research Assistant

One or more of the following:

* prioritisation of resources and everyday activities
* adaptation of activities
* adaptation of posture and seating positioning
* provision of assistive devices
* modification of the physical home environment And usual care from hospital and municipality

Usual care from hospital and municipality

Adaptive interventions aiming at compensating for functional limitations.

The Cancer Home Life Intervention

Karen la Cour, PhD

Åse Brandt, PhD

The purpose of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home Life Intervention compared to usual care on performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.

The sample size is based on the primary outcome measure: the mean Activty of Daily Living (ADL) motor ability 1.04 logits (SD 0.727) as measured by the Assessment of Motor and Process Skills (AMPS). A significance level of 0.05 would provide 80% power to detect a between-group difference of 0.3 logits requiring a sample size of N=184. An expected drop-out rate of 32% at 3 months follow-up means that 272 patients with advanced cancer must be included in the study from three hospitals.

Multiple imputation will be used to estimate a plausible value for missing data of participants that are lost to follow-up due to other reasons than death. This does not, however, apply to the primary outcome data where no estimations will be computed.

For normally distributed ratio data the intervention group will be compared with the control group using multiple linear regression analysis of mean changes from baseline. Logistic regression analysis will be used for ordinal data. Adjustments for hospital and for baseline values will be made. A modified intention-to-treat analysis will be applied. Subgroup analyses to identifiy groups that especially benefit from the intervetnion will be performed.

The cost-effectiveness analysis wil be performed with ADL motor ability as the clinical parameter, and the cost-utility analysis will be based on the calculation of Quality Adjusted Life Years (QALY). The Incremental Cost-effectiveness Ratio (ICER) will be calculated and the results summarised in a cost-effectiveness acceptability curve (CEAC).

The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation

The Cancer Home Life Intervention Study Protocol: Effectiveness on Everyday Activities and Quality of Life in People With Advanced Cancer Living at Home. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation

Observed quality of Activity of Daily Living (ADL) motor ability

Everyday activities that the participant has problems with and prioritise to have solved

The participant records every ½ hour what he/she does, where, is together with, how he/she feels mentally and physically

Autonomy and participation is assessed regarding autonomy indoors, family roles, and social life and relationships

Cancer specific health-related quality of life

University of Southern Denmark

External lecturer

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Supervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session

Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session

Exercise

Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).

Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Effects of a Specific Strength Training Regarding Activities of Daily Living (ADLs) Associated With Movement During Treatment of Leukemia or Non-Hodgkin Lymphoma in Childhood and Adolescence

The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer).

Motor performance is assessed by the MOON-test, a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children.

Physical activity is assessed using an accelerometer (movisens) for the period of 7 days.

Prinzipal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Each CO-OP session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Each session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition.The subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.

CO-OP Procedures

Individuals in the attention control group will have dose-equivalent, weekly virtual contact through the Zoom platform for 12-weeks with a a trained interventionist not involved in CO-OP treatment. The control group will control for interpersonal interaction, maturation effects, and testing effects. The focus of each session will include: (1) social interaction characterized by warmth/empathy and (2) provision of usual care CRCI educational resources (e.g. exercise, using memory aids, minimizing distractions) from MD Anderson Cancer Center. These recommendations will be provided without further instruction. Any questions that arise regarding CRCI the subject is experiencing will be answered. The therapist will debrief with the subject on any changes in CRCI symptoms. The content and duration of each call will be tracked. Each session will be recorded with two randomly selected and reviewed for fidelity.

Attention Control Procedures

Anna E Boone, PhD, OTR/L

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.

Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. cancer-related cognitive impairment (CRCI)). These cognitive changes have a devastating impact on everyday life activities, such as work/productivity, community involvement, driving, and financial management. While CRCI would likely be amenable to rehabilitation services, breast cancer survivors face two primary barriers to adequate rehabilitation, including (1) inadequate access to rehabilitation services, and (2) limited effective interventions to address CRCI.

Breast cancer survivors have inadequate access to rehabilitation services to address CRCI. A recent report sponsored by the National Cancer Institute (NCI) concluded that most NCI-designated cancer centers do not have integrated cancer rehabilitation services. Even if comprehensive rehabilitation services were provided by these centers, millions of cancer survivors live in rural areas outside close proximity to a cancer center and are more likely to experience poorer outcomes compared to urban counterparts. If rehabilitation services were provided, proximity to facilities may be a limiting factor in individuals from rural communities receiving rehabilitative care. Access to services has been further curtailed amid the COVID-19 pandemic, with calls building from national organizations for improvements in remote delivery of services.

Metacognitive strategy training (MCST) is a practice standard to address cognitive impairment in other conditions, such as traumatic brain injury and stroke. The Cognitive-Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. While current evidence supports the remote delivery of strategy-based interventions like CO-OP, this intervention has not been evaluated in breast cancer survivors with CRCI.

The investigators' overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognition, and subjective quality of life in breast cancer survivors with CRCI.

After baseline assessment, subjects will be randomized to one of two groups: (1) a 10-session Cognitive Orientation to daily Occupational Performance (CO-OP) intervention; or (2) a 10-session attention control group.

All outcomes assessors will be blinded to participant study group assignment.

Metacognitive Strategy Training in Cancer-related Cognitive Impairment

Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

Measure of telehealth usability from participant's perspective. Self-report Likert scale of 1 (disagree) to 7 (agree)

Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

Self-report measure of cognition. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). Higher scores mean fewer perceived cognitive challenges.

Self-report measure of depressive symptoms. Minimum = 0 (not at all), Maximum = 3 (nearly every day). Higher scores indicate increased depressive symptoms.

Self-report measure of quality of life. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). Higher scores indicate decreased perceived well-being and quality of life.

Objective, therapist-rated measure of general cognitive function. Total score is out of 30 points, with 26 points or higher indicating normal cognition.

Objective measure of inhibition and cognitive flexibility. Consists of 4 conditions (color naming, word reading, inhibition, and inhibition/switching). Therapist records client-corrected errors, noncorrected errors, and total time required for each domain. Increased errors and time indicate potential challenges with inhibition and cognitive flexibility.

Objective measure of inhibition, attention, working memory, and processing speed. Consists of 3 subtests (letter-number sequencing, symbol search, and coding). Increased errors and time indicate potential challenges with inhibition, attention, working memory, and processing speed.

Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory.

Objective measure of working memory. Participant is presented with single digits every 2-3 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory.

Self-reported changes in anxiety, depression, fatigue, pain, physical function, sleep, and participation. Maximum = 5, Minimum = 1. Higher scores indicate lower perceived symptoms of depression and anxiety, lower fatigue, less pain, and increased perceived independence and participation in functional activities.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma	NCT05235633	Childhood Cance...	Assessment of t...	4 Years - 18 Years	Technical University of Munich
WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER)	NCT04891471	Neurocognitive ... Quality of Life Activities of D...	Stereotactic Ra... Whole Brain Irr...	18 Years -	Mediterranean Institute of Oncology
ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma	NCT05235633	Childhood Cance...	Assessment of t...	4 Years - 18 Years	Technical University of Munich
The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients	NCT04822220	Oncology Fatigue Patient	Fatigue Self-ma...	18 Years -	Akdeniz University
The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation	NCT02356627	Activities of D... Everyday Activi... Palliative Care Cancer Quality of Life	The Cancer Home...	18 Years -	University of Southern Denmark
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients	NCT03934060	Childhood Cance...	Exercise	4 Years - 18 Years	Technical University of Munich
Metacognitive Strategy Training in Cancer-related Cognitive Impairment	NCT05505045	Breast Cancer F...	CO-OP Procedure... Attention Contr...	40 Years - 80 Years	University of Missouri-Columbia

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