Behaviors and Mental Disorders

All Conditions

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Over 12 weeks this group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training, in addition to a weekly 1 hour remote CO- OP (Meta cognitive strategy training) session. Each participant will set three occupational goals that will be the focus of the CO -OP treatment

This group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training

The CO-OP is a client-centered, goal directed approach aimed at enabling individuals to identify strategies that will improve daily function. A Weekly (1hr) session is delivered remotely via video conferencing.

Cognitive orientation to daily occupational performance (CO-OP)

The BrainHQ training targets multiple cognitive domains. The training will be delivered remotely, using a web-based program. Training progresses in an adaptive, individualized manner, based on individual progression of each participant . Participants are required to practice a minimum of half hour, three times a week (total of 1.5hr)

Computerized Cognitive Training (BrainHQ, posit science)

Yafit Gilboa, PhD

Cancer survival rates have increased dramatically in recent years. However, many survivors report cognitive decline following treatment, which significantly impairs their quality of life. Online cognitive training programs have shown promise in improving cognitive functions in cancer survivors, but most studies report limited impact of training on everyday function. A complementary treatment approach is functional treatment delivered by occupational therapists, which directly targets daily function. Combining the two approaches has the potential to overcome the limitations of both approaches, enabling improved cognitive functions and transfer to daily function. Remotely-administrated interventions further make treatment accessible and cost-effective. The current study is aimed at testing the efficacy of a novel, combined, remotely-delivered treatment approach: Cognitive Retraining and Functional Treatment(CRAFT), using a Randomized Controlled Trial (RCT) design. 90 cancer survivors will be randomly assigned to receive 15 weeks of either the combined treatment, computerized training only, or treatment-as-usual. Outcomes will be assessed at completion, and following 3 months of no contact, to test immediate and enduring effects of treatment. Baseline predictors for treatment response will be further assessed.

Positive results in the proposed study could potentially change the therapeutic landscape for rehabilitation of cancer-related cognitive decline, which currently impair the lives of millions worldwide.

Randomization will take place only after the investigator will complete baseline assessment, so the assessment procedure wont be affected by group allocation. In addition, the investigator who will assess the outcomes post intervention and at 3 month follow up will be blind to the intervention allocation.

Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment

A semi-structured interview used to assess the self-perception of clients' performance and satisfaction with their level of participation in daily functioning regarding the five most important problems they identified. The patient rates each problem on a 10-point scale indicating his level of performance (1= not able to do it at all, 10= able to do it extremely well) and level of satisfaction (1= not satisfied at all, 10 = extremely satisfied). Change is assessed by administering the interview at different time points.

Computerized Assessment will be used to assess neuro-cognitive function using five different tasks from posit science. Domains that will be assessed are sustained attention, visual working memory, speed of processing (visual and auditory) and flexibility

A self-report questionnaire for cancer patients with cognitive function issues. The tool includes 37-items assessing memory, concentration, language and thinking abilities. The items are grouped into 4 subscales: perceived cognitive impairment (PCI), perceived cognitive abilities (PCA), comments from others (OTH), and impact on quality of life (QOL). The items are rated on a 5-point Likert scale (0=never, 4 =several times a day) regarding the past 7 days, higher scores indicating greater QOL.

A patient reported quality of life questionnaire commonly used in cancer survivors. The tool consists of 21-statements on which the respondent is asked to think of the last week and determine his level of agreement to each statement on a 5-point scale (0=not at all, 4= very strongly agree), higher scores indicate greater QOL.

A self-report measure for the screening and severity of depressive symptomatology. The nine items in the questionnaire regard the frequency of symptoms within the last 2 weeks and are rated on a four-point Likert scale (0= not at all, 3=almost every day). The maximum score is 27, with higher scores reflecting more depressive symptoms.

A self-report measure used for the screening and severity of GAD, It includes 7 items describing the severity of the patient's anxiety over the past 2 weeks on a four- point Likert scale (0= not at all sure, 3= nearly every day). The sum score ranges from 0 to 21, with values of 5, 10, 15 indicated mild, moderate or severe anxiety symptoms

A self-report questionnaire used to assess rumination among adults. The RRS includes 22 items describing responses to depressed mood. Items are rated on a 4-point Likert scale (1= almost never, 4= almost always). A total score can be calculated, summing all 22 items scores (22-88), higher scores indicating more rumination.

A fatigue measure used to assess cancer patients at the active or survivor stage. The 13-item questionnaire utilizing a five-point Likert scale (0 = not at all, 4=very much so). The total score varies from 0 - 52, higher score indicating more fatigue

A self administered questionnaire used to evaluate self-efficacy. The questionnaire includes eight items that are rated on a five- point Likert scale (1= strongly disagree, 5=strongly agree). The total score ranges from 9 to 40, with higher scores reflecting better self-efficacy.

An observational measure, used to assess actual performance of client-selected activities. Score ranges between 1 (0% task completion) to 10 (100% of task completion) and is established by therapist thoroughly questioning client about performance using explicit questions.

A questionnaire used to measure co-presence and social presence of adults participating in technology based social interactions

A satisfaction questionnaire and interview were developed for the use of this study

Israel cancer research fund

Israel Cancer Association

Hadassah Medical Organization

Neoplasms

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

The arm will begin the Lumosity program at enrollment in the study.

The arm will begin the Lumosity program 3 months after enrollment in the study.

Computer-based online cognitive training program using the Lumosity cognitive training program.

Lumosity

Computer-based online cognitive training program using the Lumosity cognitive training program. The control group will receive the intervention after a waiting period of 12 weeks.

Lumosity (waitlist control)

Noha M Sharafeldin, MD,MSc, PhD

Lindsey Hageman, MPH

Noha Sharafeldin, MD, MSc, PhD

Lindsey Hageman, MPH, CCRP

Noha M Sharafeldin

A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.

The investigators propose using an "off-the-shelf" product - Lumosity (http://www.lumosity.com/) - an online cognitive training program, to address the cognitive impairment in outpatient HCT survivors. The program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.

Ideally, targeting the intervention and offering it specifically to those at highest risk (integrating clinical and genetic markers) would ensure efficacy. However, evidence is lacking on whether patients are receptive to communication of individual genetic information and whether provision of such results would lead to enhanced intervention response. To realize the high expectations of personalized medicine, patients' preferences and attitudes need to be thoroughly investigated especially as more information on genetic risk becomes available. The investigators will examine patients' genetic knowledge to determine whether factual knowledge of genetics is essential for understanding genetic risk and for informing treatment decision making in this patient population.

Cognitive Training Intervention and Attitudes Towards Genetics

Intervention Strategies to Improve Cognitive Functioning in Hematologic Cancer Survivors After Hematopoietic Cell Transplantation

Number of participants completing the 12 week intervention

Change in cognitive function will be measured using cognitive test scores at baseline and 12 weeks

Genetic factual knowledge will be measured using a 16-item survey on knowledge about genes, chromosomes, cells, and diseases and how different characteristics are inherited from parents.

Effect size of associations of sociodemographic characteristics such as age, gender, race/ethnicity, education and income levels with genetic factual knowledge of participants will be measured.

Patient ratings will be collected on a 5 Likert scale survey questionnaire to examine importance of receiving information on genetic risk of cognitive impairment post-HCT.

Patient ratings will be collected on a 5 Likert scale survey questionnaire to measure association of likelihood of genetic risk of cognitive impairment (low chance vs high chance) on intervention uptake.

Patient ratings will be collected on a 5 Likert scale survey questionnaire to measure association of likelihood of genetic risk of cognitive impairment (low chance vs high chance) on intervention adherence.

University of Alabama at Birmingham

Prinicipal Investigator

Participants will receive educational handouts and complete research testing to evaluate their physical condition prior to beginning the resistance training and dietary supplementation. Adherence will be assured as described below.

Participants will receive educational handouts and complete research testing to evaluate their physical condition prior to beginning the resistance training and placebo. Adherence will be assured as described below.

Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.

Educational handouts

Individuals in both groups will participate in an individually tailored progressive resistance training program 3 times/week for 24 weeks. During weeks 1-4 participants will be supervised twice a week tapering to once a week in weeks 5-12, every other week in weeks 13-20 and then once a month in weeks 21-24 by an American College of Sports Medicine (ACSM) Certified Exercise Specialist (trainer).

Adherence: To assure fidelity and safety of the resistance training component of the intervention, participants will initially be supervised more frequently They will complete an exercise log for each of their sessions. As the supervision level for exercise is tapered, participants may receive reminders to exercise and take their supplement/placebo via text, phone, or e-mail as needed.

Resistance training

A medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Supplementation

A placebo that appears to be identical to the medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.

Placebo

Kirsten K. Ness, PT, PhD

This study is being conducted because low lean muscle mass is prevalent among childhood cancer survivors. Lean muscle is the non-fatty muscle tissue that makes up part of the body's lean body mass. Low lean muscle mass is associated with loss of overall body strength, declining mobility and eventually, loss of independence. Among childhood cancer survivors, low lean muscle mass may contribute to reduced physical functioning and a sense of fatigue with exertion, limiting ability to participate in adequate physical activity. Loss of strength and a sense of fatigue with repeated movement make it difficult to participate in daily activities.

Although there have not been exercise intervention studies among childhood cancer survivors specifically designed to evaluate the effects of resistance training on muscle mass, studies among individuals with chronic disease, including survivors of adult onset cancers, indicate that resistance exercise improves muscle mass, muscle strength, mobility, vitality and physical activity levels. Resistance training (weight lifting) is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance.

The purpose of the study is to evaluate the effects of resistance training combined with either a protein supplement or a sports drink on changes in lean muscle mass in young adults who were treated for childhood cancer. The sports drink, for this study, is considered a placebo.

This double-blind placebo controlled study will randomize adult survivors of childhood cancer who are 18 to 44 years of age, greater than ten years post first cancer diagnosis, and with low lean muscle mass to two groups: Resistance Training + Supplement (RT+S) or Resistance Training + Placebo (RT+P). Randomization will be stratified by sex and age (18-29 and 30-44 years) in a block size of 4. Three weekly resistance training sessions will occur over a 24 week period. The participants, investigator, trainer and individuals involved in testing will be blind to group assignment.

Participants will receive information about physical activity and its health benefits. They will be randomly assigned to one of two groups to receive individually tailored resistance training three times per week for 24 weeks. One group will receive a protein supplement, while the other group will receive a sports drink (placebo).

To assess outcomes, participants will have the following research tests:

* Blood will be drawn to assess heart health.
* Questionnaires will be completed to assess physical activity and health as well as food intake.
* Blood pressure measurement.
* Electrocardiogram to assess heart health.
* Height, weight, waist and hip measurements.
* Lean muscle mass will be measured by dual x-ray absorptiometry (DEXA scan).
* Muscle strength will be measured by handgrip, knee extension, and ankle dorsiflexion.
* Walking speed to determine usual walking speed.
* Six-minute walk test to determine endurance.
* Physical activity will be monitored by having the participant complete a survey and wear a small recording device (accelerometer) for seven days.

Study Objectives:

* To evaluate the effects of 24-week supervised RT+S compared to RT+P on changes in lean muscle mass, muscle strength, walking speed, self-reported exhaustion and physical activity levels among childhood cancer survivors.
* To evaluate the effects of 24-week supervised RT+S compared to RT+P on changes in blood pressure, high density lipoprotein, triglycerides, abdominal obesity, fasting glucose, fasting insulin, and C-reactive protein among childhood cancer survivors.

Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors

Dual x-ray absorptiometry (DEXA) will be used to determine lean muscle mass. Fat free mass will be measured in the total body scanning mode.

Handgrip strength will be evaluated with a hand held dynamometer.

Knee extension strength will be evaluated with the Biodex System IV dynamometer.

Ankle dorsiflexion strength will be evaluated with the Biodex System IV dynamometer.

Usual walking speed will be evaluated by having participants complete a timed 10 meter walk test.

Endurance will be evaluated by having participants complete the six minute walk test in a level of corridor as outlined by the American Thoracic Society.

Participants will complete the physical activity monitor (PAM) component of the most recent release of the National Health and Nutrition Examination Survey to measure activity levels. The PAM collects information on intensity and duration of common activities like walking and jogging for seven consecutive days. Participants will receive an accelerometer with written instructions, programmed to begin recording 12:01 a.m. on the day after the baseline assessment (the week before they begin training) and the day after their final training appointment.

Blood pressure will be evaluated with a sphygmomanometer.

High density lipoprotein will be evaluated from fasting blood samples as part of a standard lipid panel.

Triglycerides will be evaluated from fasting blood samples as part of a standard lipid panel.

Abdominal obesity will be evaluated by measuring waist circumference with a Gulick tape measure to the nearest mm.

Glucose level will be measured from fasting blood samples.

Insulin level will be measure from fasting blood samples.

Highly sensitive C-reactive protein will be measured from fasting blood samples.

Measured using the vitality subscale of the Medical Outcomes Survey Short Form-36 (SF-36), version 2.

ATC Fitness

American Institute for Cancer Research

St. Jude Children's Research Hospital

Skin and Connective Tissue Diseases

Digestive System Diseases

Breast Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants will receive standard follow-up survivorship care, an accelerometer to measure physical activity and NCCN (National Comprehensive Cancer Network) patient materials.

Participants will receive same materials as standard of care group. In addition participants will use PAI Activity tool, Garmin activity tracker and exercise logs, and also receive periodic exercise coaching.

Use of PAI tool and self-monitoring tools to increase physical activity and reduce sedentary behaviors. Participants will receive a personalized physical assessment and counseling from healthcare provider, exercise logs and a Garmin activity tracker to use between visits and 9 exercise coaching calls between clinical visits.

PAI Tool and Exercise Coaching

Shirley M Bluethmann, PhD

The purpose of the study is to determine if a Physical Activity Index (PAI) tool that collects measures on physical activity, strength training and sedentary behavior can be used in a clinical setting to monitor patient behavior and provide specific recommendations on how to achieve and maintain behavior goals. The tool will be used after treatment is completed in breast and colon cancer survivors and will test if physician counseling combined with patient self-monitoring improves physical activity and reduces sedentary behavior over time.

Female breast cancer survivors Female/Male colon cancer survivors

The PAI Trial for Breast and Colon Cancer Survivors

Evaluating a Physical Activity Assessment and Counseling Index for Breast and Colon Cancer Survivors in Clinical Practice (The PAI Trial)

PAI Tool: frequency and time spent in strenuous moderate and mild PA over 7 days and self reported television time or sedentary screen time per week

This self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. Scores are recorded based on number of repetitions the activity was completed and the hours spent doing the activity from less than 1 hour to 9 or more hours.

Activity patterns and sedentary behavior based on 7 days of wear before clinical visit

Aggregated assessment of self-reported information about demographic data, daily activities, nutritional status, medication use and health behaviors.

For 8 items, participants indicate their confidence to execute the behavior on a 100-pt percentage scale comprised of 10-pt increments, ranging from 0% (not at all confident) to 100% (highly confident).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment	NCT04210778	Cognitive Decli... Cancer	Cognitive orien... Computerized Co...	18 Years -	Hadassah Medical Organization
Cognitive Training Intervention and Attitudes Towards Genetics	NCT03094026	Cognitive Impai... Hematologic Neo... Hematopoietic C...	Lumosity Lumosity (waitl...	21 Years -	University of Alabama at Birmingham
Impact of Resistance Training-Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors	NCT02501460	Cancer	Educational han... Resistance trai... Supplementation Placebo	18 Years - 44 Years	St. Jude Children's Research Hospital
Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment	NCT04210778	Cognitive Decli... Cancer	Cognitive orien... Computerized Co...	18 Years -	Hadassah Medical Organization
The PAI Trial for Breast and Colon Cancer Survivors	NCT05156463	Breast Cancer Colon Cancer	PAI Tool and Ex...	60 Years -	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for adult cancer survivors