Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants assigned to the LATINOS CARES condition will receive an I-FOBT kit, DVD and photonovella booklet from the study coordinator. The participant will view the DVD in a private area (headphones are available) using a portable DVD player in clinic before seeing the provider. The DVD will be about 8-10 minutes long. The participant will take the LATINOS CARES toolkit and I-FOBT home after the clinic visit. The participant will be instructed to re-review the materials and complete the I-FOBT stool sampling at home.

Participants assigned to the standard brochure (SI) will be provided a packet containing the CDC Spanish-language tri-fold brochure titled Screen for Life and an I-FOBT card. The participant will be instructed to review the materials in clinic and complete the I-FOBT stool sampling at home. This brochure describes CRC, risk factors, symptoms, screening tests, benefits of screening, and insurance coverage.

Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.

Immunochemical Fecal Occult Blood Test (I-FOBT) Kit

DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.

LATINOS CARES Toolkit

Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.

Standard Intervention

Clement Gwede, Ph.D.

The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.

After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.

Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)

Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project

Successful collection of feedback to complete production of Spanish-language LATINOS CARES Intervention.

This aim involves no statistical analysis except the summary statistics for the participants. To adapt (transcreate) and produce an educational intervention entitled LATINOS CARES (DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population. BENCHMARK: Production of Spanish-language LATINOS CARES intervention that is easy-to understand, salient, and culturally suitable.

BENCHMARK: Receipt of Immunochemical Fecal Occult Blood Test (I-FOBT home kit).

Florida Department of Health

Bankhead-Coley Cancer Research Program

H. Lee Moffitt Cancer Center and Research Institute

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

* Professionals receive audit \& feedback
* Patients (and clinicians) have access to a website with information tailored to patients with an NHL. This website gives insight into the logistic processes of each diagnostic tool and into the patients' personal care pathway.
* Standardization of diagnostic and evaluative request forms and reports for clinicians.
* Supporting material for standardizing the procedure for multidisciplinary meetings.

Implementation tools

Standard intervention consists of audit\&feedback

Standard intervention

Rosella Hermens, PhD

Nelleke Ottevanger, MD, PhD

The main objective of the proposed study is to assess the effectiveness, feasibility and costs of a tailored strategy (developed in accordance with the barriers found and current practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a common strategy of 'audit \& feedback'.

In a previous study among 22 Dutch hospitals many gaps in the care for patients with non-Hodgkin's lymphomas (NHL) were found, compared to best evidence as described in guidelines. In a problem analysis study, barriers and facilitators for good quality of NHL-care were assessed and a tailored implementation strategy was developed, based on these findings. The proposed study aims at the effectiveness, feasibility and costs of this tailored strategy to improve quality of care for patients with an NHL in a clustered randomized controlled trial in 19 Dutch hospitals.

Multilevel regression analyses will be performed to evaluate the effectiveness of both strategies. Exposure to and experiences with the strategy elements will be analysed descriptively.

Regarding the costs, the two strategies are compared with a health care perspective. The input of resources will be assessed by collecting volumes of consumed resources and multiplying these by the price of each resource unit; the implementation process and consequently costs will be estimated by an Activity Based Costing (ABC) approach. The output will be determined by the level of adherence to the NHL quality indicators.

PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care

Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma

The effect of our interventions will be measured by means of adherence to quality indicators for optimal NHL care. The effects of the audit and feedback strategy (9 hospitals) versus the tailored strategy (9 hospitals) will be evaluated using previously developed quality indicators. These indicators for optimal NHL care were developed on the basis of evidence based guidelines, literature and opinions of clinicians about NHL care in a previous study and were validated.

To study the feasibility of both strategies, a process evaluation has to give insight into the mechanisms and processes responsible for the result (= extent of adherence to the indicator set for optimal NHL care). The actual 'exposure' of the patients and professionals to the implementation elements, together with their experience with these elements may have influenced the final result (success or failure of adherence). Data about 'exposure' to the different interventions will be collected using questionnaires.

Non-adherence to the multidisciplinary NHL guideline may lead to unnecessary medical interventions and more complications, and subsequently to efficiency losses. This economic evaluation compares the two implementation strategies. The perspective of this economic evaluation will be a health care perspective. Both the costs of the implementation strategy and changes in health care consumption will be assessed. The outcome should facilitate local health care decision making on implementation.

Morbidity is an important outcome measure for the effect of the intervention strategy.

Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.

Radboud University Medical Center

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Breast Neoplasms

Obesity

Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)

Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)

The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.

Game intervention

The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.

Elizabeth Lyons, PhD, MPH

The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.

Habitual physical activity decreases risk of multiple negative health outcomes, including breast cancer recurrence and mortality. It is also associated with better quality of life and reducing negative effects of cancer and cancer treatment. However, most breast cancer survivors do not engage in sufficient physical activity. Behavior change interventions produce short-term increases in activity but have difficulty motivating sustained active lifestyles over longer periods and are not equally effective in women of different races/ethnicities. The purpose of this study is to test a novel intervention that uses video games and storytelling to increase motivation. Video game mechanics increase enjoyment and feelings of autonomy (control), competence, and relatedness to others. All of these feelings are associated with motivation for activity and, in turn, sustained activity over time. Additionally, narrative storytelling is an effective method of persuading individuals to change their behavior. We propose that play of active video games that include compelling storylines will increase physical activity among a diverse sample of postmenopausal breast cancer survivors.

To test this hypothesis, we will conduct a clinical trial that compares the enhanced intervention (story-based video games) to a standard intervention in 90 sedentary, overweight postmenopausal breast cancer survivors. Participants in the enhanced group will receive a mobile device and accessories with two story-based video game applications installed. The games incorporate behavior change strategies such as self-monitoring and feedback while also using game mechanics and a lengthy storyline to motivate physical activity. Participants in the standard group will receive the same mobile device with an electronic activity monitor and its companion feedback application. Both groups will receive brief weekly telephone counseling. By comparing two groups that both receive typical behavior change intervention components (counseling) and a novel electronic intervention, we will be able to investigate the specific effects of game mechanics and storytelling on motivation and physical activity. We will measure changes in physical activity, fitness, function, and quality of life from the beginning of the study to 6 months. We will also investigate further changes during an additional 6 month follow-up period in which participants keep their intervention tools but do not receive any counseling, to measure maintenance of activity. This project will develop and test a promising, innovative intervention that has the potential to be used on a widespread basis in clinical and community settings.

Self-monitoring Activity: a Randomized Trial of Game-oriented Applications

Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)

Minutes of moderate-vigorous physical activity measured over a 7 day period

We will use a 6 minute walk test to measure fitness

We will use the Senior Fitness Test to measure physical function

We will use a computerized PROMIS measure

Weight will be measured using a calibrated scale

We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)

We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.

We will use a computerized PROMIS measure specific to cancer patients/survivors

We will use the Functional Assessment of Cancer Therapy - Breast measure

Behavioral Regulation in Exercise Questionnaire-2 will be used

Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire

Participants will self-report their perceptions of the playfulness of the intervention apps

We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline

We will measure the extent to which participants in the narrative group felt like they identified with their game character

Minutes of moderate-vigorous physical activity over a 7 day period

We will measure weight using a calibrated scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)	NCT03078361	Colorectal Canc... Colorectal Carc...	Immunochemical ... LATINOS CARES T... Standard Interv...	50 Years - 70 Years	H. Lee Moffitt Cancer Center and Research Institute
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care	NCT01562509	Non-Hodgkin Lym...	Implementation ... Standard interv...	18 Years -	Radboud University Medical Center
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications	NCT02341235	Breast Cancer Obesity	Game interventi... Standard interv...	45 Years - 75 Years	The University of Texas Medical Branch, Galveston
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)	NCT03078361	Colorectal Canc... Colorectal Carc...	Immunochemical ... LATINOS CARES T... Standard Interv...	50 Years - 70 Years	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for standard intervention