Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The assessment of the end points will be made at three moments: at baseline, at 8 weeks (at the end of the program) and at 12 months of follow-up. The intervention will consist in: 1)Feedback daily or weekly of physical exercise and diet through the application (notice) according to the records of diet and exercise and following recommendations of International Organizations 2) Participation in three sessions of seminars (1 hour each every 15 days) on habits of life healthy and cancer and the self-regulation through measurements performed by the application 3) Calls weekly to the patients of way individual to comment possible errors or doubts about the application, of 10 min of duration (8 calls).

Dietary and physical activity recommendations trough a mobile application

mHealth application

IRENE CANTARERO VILLANUEVA, PhD

The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors (CCR).

Background: Among all types of cancer, colorectal cancer (CRC) is one of the most frequent, and Spain is among the countries with the highest incidence of CCR with a ratio of about 100,000 people. Fortunately the data of survival are very encouraging according to the National Cancer Institute, it is around 70% at 5 years when the cancer is regional and it could reaching up to 90% when it is more localized. During this survival, however, a high number of patients suffer physical and psychological sequelae that limited their quality of life.

This is why that, to try to minimize these effects, it is essential to try to instill healthy habits (food and physical exercise), since as it confirms the current literature, obesity is related to a lower survival and a greater presence of other diseases, and increased consumption of fruits and vegetables and physical activity practice improves the quality of life in survivors of CRC. However, changes in lifestyle are complicated to maintain long-term. In this sense, the technological development offers possibilities to try to resolve this lack of adherence in patients with cancer. However, the evidence highlights the need to improve knowledge about its applicability and efficacy in patients with this pathology betting on technologies more innovative.

Objective: The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in CRC survivors. In a more specific way, analyze the effectiveness of the implementation to maintain healthy lifestyle habits in patients newly diagnosed with CRC through adherence to a healthy lifestyle (exercise and diet), as well as facilitate changes in clinical variables: body composition, quality of life, physical condition related to health (functional ability, strength and flexibility).

Methods: 54 patients will be recruited from the Virgen de las Nieves Hospital from Granada (Spain). Patients will be randomized in two groups: control and experimental group. The assessment of the end points will be made in IMUDS (Instituto Mixto Deporte y Salud) from Granada (Spain) at three moments: at baseline, at 8 weeks (at the end of the program) and at 12 months of follow-up. The intervention will consist in: 1)Feedback daily or weekly of physical exercise and diet through the application (notice) according to the records of diet and exercise and following recommendations of International Organizations 2) Participation in three sessions of seminars (1 hour each every 15 days) on habits of life healthy and cancer and the self-regulation through measurements performed by the application 3) Calls weekly to the patients of way individual to comment possible errors or doubts about the application, of 10 min of duration (8 calls). The control group will follow the usual indications of their oncologist and completion of the study will be offered access to the application.

Discussion: Health mobile applications (mobile health, mHealth) are potential tools to address the needs of cancer patients, because it enabling personalized interventions and the adherence to them. Previous studies have showed: 1) Are effective for weight loss in people with obesity or overweight. 2) You can count on are to promote a healthy lifestyle focused on the loss of weight in cancer patients. 3) Strategies based on self-regulation will not only improve the regulation of the exercise by the patient, but they also produce a greater adherence to the same. However, despite all these advances, are few them studies that have analyzed the efficiency of mobile applications as tool appropriate for foster the acquisition of habits of life healthy in cancer patients. Therefore are necessary studies that improve the adequacy of interventions to the needs of patients with CRC with support from technologies that show its effectiveness.

A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer

Effectiveness of a Mobile Application for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer: a Randomized Controlled Trial

in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

It will be measured with a plastic tape. Waist circumference was assessed midway between the lower rib margin and the top of the iliac crest (cm) at the end of normal breathing.

It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter.

it will be assessed though FITBIT CHARGE HR bracelet in kcal/day.

through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density.

the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes.

it will be assessed with trunk curl test. Patient through a trunk curl has to keep an isometric position separating the inferior angle of the scapulae from the stretcher as long as possible until 90 seconds as maximum.

it will be assessed with chair sit and reach test. Patients were instructed to slide their hands as long as possible to touch their toes. The centimeters that were missing (minus score) or exceeded(plus score) from the tip of the foot were registered.

Universidad de Granada

The OT Health and Wellness Program will have four weeks of education and individual integration intervention modules:

Week 1: Sleep Hygiene Week 2: Fatigue Management Week 3: Cancer-related cognitive impairments Week 4: Stress Management Each session will last 1.5 hours (45 minutes of group education and 45 minutes of individual modifications and strategy recommendations.

The OT Health and Wellness Program will have four weeks of education and individual integration intervention modules. One of the investigators will lead each of these weekly modules under the direct supervision of the Principal Investigator. Investigators will be trained to provide the standardized educational module for each topic area and for using outcome measures. Each module will have an identified theme and information provided in each group will be education to topic, evidence based literature on intervention strategies, lifestyle, or environmental modifications that improve performance of daily activities that will last approximately 45 minutes. After, group sharing of ideas and individual identification of weekly goals for integration of 1-3 targeted interventions will occur and last approximately 30-45 minutes).

Occupational Therapy Health & Wellness Education

Katie Polo

The number of cancer survivors today is growing exponentially and many survivors have unmet needs due to the late side effects of treatment. The purpose of this study is to explore the impact that a four-week Occupational Therapy Health and Wellness Program has on perceived satisfaction and performance of daily activities, fatigue, sleep quality, and health-related quality of life among adult community-dwelling cancer survivors.

Eligibility criteria for prospective participants includes cancer survivors with a past or present diagnosis that are at least 18 years old, able to consent, are English speaking, are able to fill out demographic information as well as pretest/posttest questionnaires, have indicated concerns within performance of daily activities and are able and willing to participate in a four-week Occupational Therapy Health and Wellness Program.

This quantitative study will use a prospective, one-group pretest-posttest design to explore the effects of a four-week Occupational Therapy Health and Wellness Program. Data that will be collected to track changes include physical, mental, and social health (measured by PROMIS questionnaire); fatigue levels (measured by the MAF questionnaire); Sleep quality (measured by the PSQI questionnaire); and self-perceived occupational performance and satisfaction (measured by the COPM interview/questionnaire) of community-dwelling cancer survivors.

Descriptive statistics will be used to compare pretest/posttest scores. Matched pairs t-test and Wilcoxin signed ranks test will be used if data is normally distributed. Normality will be tested by Shapiro wilks test and all data will be analyzed using t-tailed tests with significance set at .05.

The purpose of this study is to explore the impact that a four-week Occupational Therapy (OT) Health and Wellness Program has on perceived satisfaction and performance of daily activities, fatigue, sleep quality, and health-related quality of life among adult community-dwelling cancer survivors.

The research questions for this study are as follows:

1. What changes occur in community-dwelling cancer survivors in Physical, Mental, and Social Health from the Patient-Reported Outcomes Measurement Information System (PROMIS) after a four-week Occupational Therapy Health and Wellness Program from initial pretest to posttest?
2. What changes occur in community-dwelling cancer survivors in self-perceived occupational performance and satisfaction from the Canadian Occupational Performance Measure (COPM) after a four-week Occupational Therapy Health and Wellness Program from initial pretest to posttest?
3. What changes occur in community-dwelling cancer survivors in fatigue from the Multidimensional Assessment of Fatigue Scale (MAF) after a four-week Occupational Therapy Health and Wellness Program from initial pretest to posttest?
4. What changes occur in community-dwelling cancer survivors in sleep quality from the Pittsburgh Sleep Quality Index (PSQI) after a four-week Occupational Therapy Health and Wellness Program from initial pretest to posttest? It is hypothesized that there will be improvements in participants self-perceived occupational performance and satisfaction, fatigue levels, sleep quality, as well their mental, physical, and social quality of life after participation in a four-week OT Health and Wellness Program. This study will explore occupational therapy health and wellness cancer programming in a new service setting of the community. It additionally will integrate innovative occupational therapy community cancer programming looking at called for participation outcomes.

METHODS This quasi-experimental study will use a single group pretest-posttest study design to explore the effects of a four-week Occupational Therapy Health and Wellness Program on physical, mental, and social health (PROMIS), fatigue levels (MAF), Sleep quality (PSQI), and self-perceived occupational performance and satisfaction (COPM) of community-dwelling cancer survivors.

Participants This study defines cancer survivor as any person who has been diagnosed with cancer from the time of diagnosis through the remainder of their life. Therefore, cancer survivors will be included irrespective of their phase of survivorship (i.e. actively receiving treatment, remission etc.).

An a priori power analysis using G\*Power 3.1 was performed for a dependent-sample t test with the following parameters: two-tailed test, power of .80, a Type I error (α) of .05, and a medium effect size (d = .50). A minimum required sample size of 34 was determined. Taking into account attrition rate (25%), a target sample size is set for 43. Using results reported in a similar study of cancer survivors with an activity-based one week health program using the COPM, an effect size was calculated at .53 so the minimum sample size would be 30).

Data collected will be de-identified by using a participant code (first three letters of the participant's mother's first name and the last three digits of the participant's phone number). Participant IP addresses will not be collected in Qualtrics. A list of participant codes and their corresponding phone numbers will be stored on an encrypted google drive with access for investigators only in order to make reminder phone calls for meeting times. The study survey can be found at: https://uindy.co1.qualtrics.com/jfe/form/SV_56XfqHqrkLFYtNj

Procedures Recruitment. Survivors that are actively participating in programming at Cancer Support Communities Central Indiana location as well as their satellite facilities (Community Hospital, IU Health Simon Cancer Center, St. Vincent Cancer Care, and Hendricks Regional Health), and CSC community network partners (Little Red Door, Pink Ribbon etc.) will receive an informative flyer about the program. The program flyers will be posted at CSC and their satellite facilities as well as emailed to other community network partners for distribution. The OT Health and Wellness Program information will also be placed on CSC's programming schedule. Programming recruitment will also be through word from the investigators to their professional networks.

Screening. When a survivor calls to inquire about the OT programming, investigators will check if their results from the CSC Distress Screening Tool indicate the need for OT services. Those survivors that have indicated concerns of great severity on Cancer Support Community (CSC) Distress Screening Tool (Likert Items: very serious, serious, and moderately serious) in OT service provision areas related to finding meaning and purpose in life, disruptions in school/work/home life, fatigue, and sleep problems will be included in the study. This screening tool will be utilized to determine if participants are in need of the four-week OT Health and Wellness Program services and this data will be retained for the study.

Informed consent. Informed consent will happen at the survivor's first appointment with either the primary investigator or one of the co-investigators. Informed consent will be reviewed by one of the investigators and potential participants will indicate voluntary consent on Qualtrics. If the participants indicates voluntary consent to participate by continuing in Qualtrics, they will proceed into the COPM questionnaire. If the participant does not consent, it will take them out of Qualtrics. No data will be collected on those that do not provide voluntary consent.

Intervention. The OT Health and Wellness Program will have four weeks of education and individual integration intervention modules. One of the investigators will lead each of these weekly modules or students in the UIndy OTD program enrolled in OTD 620 Cancer Survivorship elective course will run the modules under the direct supervision of the Principal Investigator. Students will be trained to provide the standardized educational module for each topic area and will not be interacting with any study data. Each module will have an identified theme and information provided in each group will be education to topic, evidence based literature on intervention strategies, lifestyle, or environmental modifications that improve performance of daily activities that will last approximately 45 minutes. After, group sharing of ideas and individual identification of weekly goals for integration of 1-3 targeted interventions will occur and last approximately 30-45 minutes). The program will take place at CSC or one of their satellite facilities previously listed.

Data Analysis. Descriptive statistics will be used to describe the baseline and post-intervention characteristics of the sample. Nominal data will be presented as frequencies and percentages, while interval and ratio data will be reported as means and standard deviations or medians and interquartile ranges, dependent on whether the data are normally distributed. To determine if there is a significant difference in scores from pre-intervention to post-intervention, scores will compared using a paired t test, if the data are normally distributed, or the non-parametric Wilcoxon signed-ranks test if the data are not normally distributed. Normality will be determined using the Shapiro Wilk test. Data will be analyzed using IBM SPSS Statistics for Windows, Version 25.0. All comparisons will be two-tailed and a significance level of less than .05 will be considered statistically significant.

Integrating an Occupational Therapy Health and Wellness Program Into an Existing Cancer Support Community

Integrating an Occupational Therapy Health and Wellness Program (OT-HAWP) Into an Existing Cancer Support Community

Canadian Occupational Performance Measure (COPM) is a client centered outcome instrument that measures changes in a client's self-perception of occupational performance and satisfaction over time, and has been found to be a valid, reliable, and clinically useful outcome measure for occupational therapy research. In step two, the client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five identified problems.

Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-G) is an open access, person-centered questionnaire that measures physical, mental, and social health of adults, has been rigorously tested, has strong psychometric properties, and has cancer specific reference values. It is a 5 point likert scale.

Pittsburgh Sleep Quality Index (PSQI) is an open access, self-reported questionnaire that measures sleep quality and patterns in adults over a 1-month time interval, and has been found to be a reliable and valid assessment of sleep problems.

Multidimensional Assessment of Fatigue Scale (MAF) is an open access, self-reported questionnaire that measures fatigue with recommended use in cancer rehabilitation.

Indiana Clinical and Translational Sciences Institute

University of Indianapolis

Assistant Professor

Behaviors and Mental Disorders

Symptoms and General Pathology

Depression

Anxiety Disorders

Depressive Disorder

Pain

Head and Neck Neoplasms

Central Nervous System Stimulants

All Drugs and Chemicals

Analgesics

Anti-Infective Agents

Anti-Infective Agents, Local

Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care

Treatment as usual (TAU; i.e. pharmacological treatments and advices)

Six education areas was offered: pain and pain physiology, pain medication, side effects and prevention of side effects, abuse of medications, sleep advice and advice on anxiety.

Education

The following instructions on self-care for pain relief: apply ice or crushed ice in the oral cavity, lubricating and antiseptic mouth rinses, pain relieving gel, tongue movements and gaps exercises. Prevention of dryness in the mouth and throat; saliva stimulants and saliva substitute agents in different preparations, increased measures of good oral hygiene. Physical activities and regular rest once to several times per day. Sleep restriction and measures to treat sleep disorders.

Self Care

Treatment as usual (TAU)

Bjorn Gerdle, Professor MD

The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.

The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer

All patients who referred to the Pain and Rehabilitation Centre at the University Hospital, asked about participation in the study. Of those who agreed to participate every second patient were distributed to the control group versus intervention group.

Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness

Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)

Pain intensity the actual day using a numeric rating scale.

Pain interference the actual day using a numeric rating scale

Perceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)

Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)

Depression scale of Hospital and Depression Scale (HADS)

Anxiety scale of Hospital and Depression Scale (HADS)

Total score of Pain Catastrophizing scale

Linkoeping University

Professor MD

Skin and Connective Tissue Diseases

Breast Neoplasms

Amino Acids

Neratinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

neratinib

Puma

Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.

Study Evaluating HKI-272 Administered to Healthy Subjects

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Healthy Subjects.

Puma Biotechnology, Inc.

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

NLit-UK linguistic and cultural adaptation (NLit-UK) 2 x nominal consensus groups evidence review and topic expert engagement

Nominal consensus group

Nutrition Literacy Measurement Tool validation (NLit-UK). Target sample 366 on treatment cancer patients confirmatory binary analysis for validity and reliability.

Observational cohort (validity and reliability testing)

Laura J Miller, MBiol, PgDip

An exploration of the impact of nutrition literacy on ability of cancer patients and their support networks to get, understand and use nutrition information during cancer treatment.

The study is composed of two component projects:

Project A: Validation of a NLit tool for UK population.

NLit tool is a measurement tool developed at Kansas University to measure nutrition health literacy. It assesses the following functional literacy skills: numeracy \& literacy and the following nutrition knowledge fields: macronutrients, food labels, portion sizes, food groups and consumer skills.

This project has two phases:

Phase A: Nominal consensus groups x 2 - consumer adaptation and tool review for UK use and pilot testing of electronic tool.

Phase B: Testing adapted tool in a group of cancer patients for statistical validation.

Project B: Planned survey of people with cancer and their families to explore experiences of access to nutrition information

This survey is a combination of validated and unvalidated questions built on models of nutrition health literacy. With validated fields being used to evaluate and understand responses to unvalidated questions.

It explores access to nutrition information, self-efficacy, confidence, health care infrastructure and support with nutrition information, population demographics, food security, sources of nutrition information, perceived practical skills and knowledge base.

Nutrition Health Literacy of Cancer Patients and Their Support Networks.

Implications of Nutrition Health Literacy on Accessibility and Engagement With Nutrition Information in Cancer Patients and Their Support Networks

Measured by UK modified NLit developed during study cultural and linguistic modification of (Gibbs et al., 2018 - original validation) - 64 item questionnaire

Scoring interpretation from study: NLit-UK (63item) and NLit-UK short (42-item) NLit-UK (63-item): Scoring interpretation is ≤44 correct is "likelihood of poor nutrition literacy"; 45-57 is "possibility of poor nutrition literacy"; and scores ≥58 is "likelihood of good nutrition literacy

NLit-UK short (42-item): Scoring interpretation is ≤28 correct is "likelihood of poor nutrition literacy"; 29-37 is "possibility of poor nutrition literacy"; and scores ≥39 is "likelihood of good nutrition literacy

Validated tool - 6 part question (Rowlands et al, 2013)

Scoring interpretation: low health literacy (≤1), intermediate health literacy (2-3), adequate health literacy (≥4).

Did you receive any nutrition advice as part of your care for any of these conditions?" (Yes or No).

What is the highest grade or level of schooling you completed? GCSE D or less/ GCSE C or above/ Unsure

At the end of the month, how much money are you able to put aside? (Nothing, £100 or less, £101-250, £251-500, £501-1000, more than £1000, do not want to say).

Response sets: Didn't know enough to consider / Not important ; Moderately Important; Very or extremely important

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer	NCT02837159	Colorectal Canc...	mHealth applica...	18 Years - 85 Years	Universidad de Granada
Integrating an Occupational Therapy Health and Wellness Program Into an Existing Cancer Support Community	NCT03888547	Cancer	Occupational Th...	18 Years -	University of Indianapolis
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness	NCT03089736	Pain Head and Neck C...	Education Self Care Treatment as us...	18 Years -	Linkoeping University
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness	NCT03089736	Pain Head and Neck C...	Education Self Care Treatment as us...	18 Years -	Linkoeping University
Study Evaluating HKI-272 Administered to Healthy Subjects	NCT00366600	Healthy	neratinib	18 Years - 50 Years	Puma Biotechnology, Inc.
Nutrition Health Literacy of Cancer Patients and Their Support Networks.	NCT03978312	Cancer Oncologic Disor... Haematological ... Nutrition Aspec...	Nominal consens... Observational c...	18 Years -	Nottingham University Hospitals NHS Trust
A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer	NCT02837159	Colorectal Canc...	mHealth applica...	18 Years - 85 Years	Universidad de Granada

Spots Global Cancer Trial Database for health

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

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