Neoplasms

Digestive System Diseases

All Conditions

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

A decision support intervention that is a literacy sensitive paper based tool with educational information targeted to the patient's age and gender.

The placebo comparator is an attention control with information about driving tips for drivers age 65 and older.

Targeted by age and gender with 3 components.

1. Educational component
2. Values clarification exercise
3. Individualized decision making worksheet

The intervention or control condition is administered before the index visit with the patient's provider.

Making A Decision About CRC Screening

This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.

Drivers 65 Plus

Carmen L Lewis, MD, MPH

Rowena J Dolor, MD, MHS

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.

The investigators propose a randomized controlled trial at the patient level to determine the efficacy of a colorectal cancer screening decision support intervention for patients ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the intervention will prepare patients for individualized decision making with their providers and result in an improvement in appropriate CRC screening decisions and screening outcomes. To assess appropriate CRC screening decisions and screening, the investigators will use a classification scheme derived from the literature based on age and the Charlson Comorbidity Index. Using this scheme, appropriate screening will include screening for those in the best health because they are likely to benefit, no screening for those in the worst health because they are unlikely to benefit, and evidence of a discussion about CRC screening for those in the intermediate health group because the benefit is unclear.

Elders Preferences in Care Decisions

Improving Appropriate Colorectal Cancer Screening in Elderly Patients

The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

The proportion of participants classified as having appropriate colorectal cancer screening decisions in the intervention group will be compared to the control group. Appropriate screening decision making is a combined outcome measure using patient report of intent to complete or not complete CRC screening tests and discussions about CRC screening with their provider. This outcome will be measured immediately after the patient and provider index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

For the mediation analysis covariates will be evaluated as potential mediators. The potential mediators to be examined include adequate preparation for individualized decision making (adequate knowledge+ clear values); knowledge scores, screening preference before the index visit, decisional balance, reported discussion during the index visit, gender, previous screening, functional status, and literacy level.

Once we have tested our hypothesis for the main effects, we will also perform hypothesis-generating exploratory analyses to examine effect of the intervention in sub-groups of patients. We will examine the effect in the three strata (best, intermediate, worst health groups) defined by age and Charlson comorbidity score.

For this analysis, appropriate screening test completion will include stool cards for all age groups and health groups. Analyses described for the primary outcome will be performed using this classification of appropriate screening test completion.

Duke University

Agency for Healthcare Research and Quality (AHRQ)

University of North Carolina, Chapel Hill

Symptoms and General Pathology

Behaviors and Mental Disorders

Fatigue

Quality of Life

Exercise

Stacey Young-McCaughan, RN, PhD

The purpose of this study is to compare the health outcomes of a 12-week exercise program focused on aerobic training (using a treadmill) to a 12-week exercise program focused on resistance training (using Thera-Bands) in sedentary patients within 6 months of completing treatment for cancer.

Comparing Aerobic to Resistance Training in Recovery From Cancer

TriService Nursing Research Program

Stacey Young-McCaughan

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Syndrome

Leukemia

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Preleukemia

Myelodysplastic Syndromes

Leukemia, Lymphoid

Leukemia, Myeloid

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Marrow Diseases

Precancerous Conditions

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Patients with Myelodysplastic Syndromes (MDS), any IPSS (International Prognostic Scoring System) risk, or Acute Myeloid Leukemia (AML) who participated in the Geriatric Assessment in Haematology (GAH) study(CEL-GAH-2011-01).

Patients with Multiple Myeloma (MM), symptomatic or asymptomatic who participated in the Geriatric Assessment in Haematology (GAH) study (CEL-GAH-2011-01).

Patients with Chronic Lymphocytic Leukemia who participated in the Geriatric Assessment in Haematology (GAH) study (CEL-GAH-2011-01).

Marta Duran, PhD

This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric properties of the GAH study (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be collected to ensure its retrospective nature, thereby reflecting routine clinical practice and non-interference in the physician's clinical practice

Patients over 65 are the most prevalent population in oncological clinical practice. It is also expected that this group of patients will increase significantly in the coming decades as a result of increased life expectancy and the aging population.

Overall, the population is aging and this aging is accompanied by an increase in the prevalence and incidence of age-related diseases, such as cancer. So much so that approximately 60% of new cancer cases and 70% of the overall cancer mortality occurs in patients aged 65 and over.

Despite the high incidence of cancer in the elderly and its peculiarities as opposed to young patients, from the point of view of health, the management of elderly patients is especially complex because there are few data on the evaluation and treatment thereof. Often, older patients are underrepresented in clinical trials and treatment guidelines, resulting in a population that is undertreated or at greater risk of suffering treatment-related toxicities.

In this respect, both the National Comprehensive Cancer Network (NCCN) and the International Society of Geriatric Oncology (SIOG, its acronym in Spanish) agree that age should not be an impediment to treat these diseases. Optimal management requires strategies specifically directed to the clinical and biological characteristics of this type of patient and they recommend an appropriate assessment of the patient as part of a safe and effective approach to haematological malignancies in the elderly.

There is scientific basis supporting the need for the elderly patient with cancer who will receive a particular treatment to be specifically assessed by means of a comprehensive geriatric assessment (CGA). Geriatric assessment is essential since it is a tool that integrates all aspects of the patient's life that could affect the course of the disease and response to treatment, such as functional status, comorbidities, cognitive, emotional or nutritional status and social environment. In addition, the CGA is a tool to identify the possible presence of fragility, characterized by a decrease in physiological reserves that conditions a lower response to stress and is associated with a lower risk of disability and increased morbidity and mortality.

Although currently it is assumed that chronological age is not synonymous with biological age, the decision on cancer treatment often falls on the subjective assessment of the physician, as few healthcare centres are performing comprehensive geriatric assessment in the oncology setting. Although various tools have been developed for this purpose, they have not been incorporated into routine clinical practice due to the time required, their length and the resources needed to gather information.

Therefore, there remains a need to find a scale for comprehensive assessment of the health status of elderly patients (≥ 65 years) with haematologic malignancies that incorporates the essential dimensions of the geriatric assessment, with the same precision of valid tools currently available, and that is simple, straightforward and easy to apply, so that it can be used in daily practice and assist to make clinical decisions objectively.

It was hypothesized that a simplified geriatric assessment could be a better tool for assessing elderly patients, instead of considering only age or subjective clinical impression, when deciding whether or not to prescribe active treatment. Such a tool would represent the real and multidimensional nature of aging, which is associated with an increased incidence of chronic diseases and geriatric syndromes with consequences on vulnerability and patient survival.

As described above, Bonanad et al. designed and developed a new comprehensive assessment scale aimed at elderly patients (≥ 65 years) diagnosed with haematological diseases \[myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML), multiple myeloma (MM) and chronic lymphocytic leukemia (LLC)\], the Geriatric Assessment in Haematology (GAH). The purpose of this scale is to help doctors identify objectively and reliably those elderly patients with haematological diseases who are eligible for intensive treatment versus those who are most vulnerable.

The GAH scale is a tool of 30 items grouped into eight relevant dimensions of geriatric assessment, which include:

1. Number of drugs: Polypharmacy has been associated with adverse effects related to frailty, disability, mortality and falls in the elderly, and it may be more frequent in elderly patients with cancer.
2. Gait velocity: Determining the time taken to walk four meters at a normal pace is a method of assessing gait velocity that is widely used in the literature due to its simplicity, speed and reliability. There is sufficient evidence to consider walking speed as a strong and consistent predictor of adverse outcomes in older patients, and its use as a single item has proven to be at least as sensitive as compound instruments in predicting most of these results long-term.
3. Mood: We propose as a screening test for depression a single item extracted from the Center for Epidemiologic Studies Depression Scale (CES-D), widely used for its validity and reliability. This unique and simple measure of depression was shown to be strongly correlated with a clinical diagnosis of depression; it detects patients rarely or sometimes depressed and patients depressed occasionally or much of the time.
4. Activities of daily living: The assessment of functional status in older people should include assessment of so-called basic activities of daily living (ADLs), including the skills necessary for life such as dressing, grooming, bathing and feeding. ADL is a tool that has been used as a predictor of hospitalization and mortality in elderly patients.

   To develop the activities of daily living (ADL) of the GAH scale, items were selected from the Vulnerable Elders Survey (VES-13) with two additional questions.
5. Subjective health status: The patient rating his or her own health is another worthwhile parameter. This is why a self-rated health item was also selected, also included in the Vulnerable Elders Survey (VES-13). Recently it has been determined that this is a predictive parameter of functional impairment or death.
6. Nutrition: Nutritional deficit is a common serious problem in elderly patients, contributing significantly to morbidity and mortality associated with this group of people. To determine this dimension, some items were selected from the short version of the full questionnaire, Mini-Nutritional Assessment. This tool was developed and validated in representative samples of older patients worldwide and it identifies subjects at nutritional risk.
7. Mental State: To evaluate mental state, all the items were selected that make up the Short Portable Mental Status Questionnaire (SPMSQ). It is designed and validated to assess four aspects of intellectual functioning: short and long-term memory, orientation, information on daily events and computing ability. It has been observed that cognitive impairment is also an independent predictor of mortality and the end of chemotherapy.
8. Comorbidity: Six variables of comorbidity and habits were considered (diabetes mellitus, cancer, lung disease, heart failure, smoking), drawn from the Prognostic Index for 4-year Mortality in Older Adults.

The final score of the GAH scale has not yet been defined. At present, for purely exploratory purposes, each of the dimensions was assigned a dichotomous score (0 or 1), generating a provisional score ranging from 0 (best possible health status) to 8 (worst health status). The recently published study showed that the GAH scale is a measuring instrument that meets the expected psychometric properties (feasibility, ceiling-floor effect, reliability and validity) for a tool to determine health status in elderly patients with haematological diseases. Also, it has been determined that this scale is sensitive to change \<pending (reference short report)\>, since it is able to detect changes in the health status of patients after a certain time and is able to predict survival in this patient group.

This study aims to determine the weights of each of the dimensions of the GAH scale, as well as cut-off points for the final score of the scale that will be used to predict treatment tolerability in elderly patients diagnosed with MDS/ AML, MM or CLL (chronic lymphocytic leukemia).

A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms

Retrospective Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms

Number of patients, which suspend or modify treatment due to toxicity

Determination of number of drugs that patients were taken.

To determine the time taken to walk four meters at a normal pace.

Assessment of so-called basic activities of daily living (ADLs), including the skills necessary for life such as dressing, grooming, bathing and feeding

Six variables of comorbidity and habits were considered (diabetes mellitus, cancer, lung disease, heart failure, smoking)

Number of patients that due to their fragility, the physician decided to modify the planned start treatment.

Percentage of patients who discontinued the planned treatment due to toxicity

Percentage of patients who modified the planned treatment regimen due to toxicity

Percentage of patients who suspend or amend the treatment regimen due toxicity

Number of patients who were admitted to hospital as a result of toxicity

Celgene

Patients with Myltiple Myeloma, symptomatic or asymptomatic

Patients with Myelodysplastic Syndromes (MDS), any International Prognostic Scoring System (IPSS) risk, or Acute Myeloid Leukemia (AML)

Patients with Chronic Lymphocytic Leukemia

Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days

Geriatric Assessment of Health Status Scale administration

Jose Luis Garcia, PhD

The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology therapies.

Treatment planning must consider several health indices that are useful when it comes to detecting geriatric problems that could affect the patient's treatment experience. The complete comprehensive geriatric evaluation stands out as cornerstone among other validated tools that do not work as isolated instruments; however, its length and complexity may hinder its routine use in clinical practice for decision making.

The purpose of this study is to validate a comprehensive health status assessment scale in elderly patients (≥65 years) with hematological malignancies that, while integrating the essential dimensions of geriatric assessment and, with the same precision as the currently available valid tools, is shorter and easier to apply, so it can be incorporated into the daily practice and that aids in clinical decision making objectively.

If so, this information would help identify patients that could benefit from a specific oncology treatment, thus contributing to developing a targeted intervention plan and to optimizing the cancer results in this patient population.

Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies

A composite variable comprised of all the dimensions that make up the GHA questionnaire will be obtained on stable patients as a result of the implementation of a questionnaire by two independent evaluators: one investigator and one duly trained health professional.

Infections

Lymphoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

Burkitt Lymphoma

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Diffuse Large B-Cell Lymphoma

Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.

Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Breast Neoplasms

Pain

Group A: Cold color scheme, room facing North

Group B:Cold color scheme, room facing South

Group C: Warm color scheme, room facing North

Group D: Warm color scheme, room facing South

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

Chromatic Environment

Room Orientation

Paula Gomez Vela, BS

Margarita Pérez Ruiz, MD,PhD

Almudena Corredera, RN

Margarita Pérez Ruiz, MD, PhD

The primary objective is to examine the acute effect of color, room orientation (affecting amount of luminosity) on perceived health status and stress levels in oncologic patients during chemotherapy sessions at outpatient clinic. The secondary objectives will be to study the effect on vital signs (body temperature, heart rate, systolic blood pressure). Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South) for each session. For the next session, patients will be assigned a new condition. Assignment of sequences will be randomized for each patient.

20 patients will be randomly assigned to one of the four groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be treated per standard of care.

Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South), and they will be assigned a new condition at each next visit. The sequence will be assigned randomly to each patient. During each of the four visits, the patients will be treated per standard of care during their chemotherapy sessions. Outcome variables will be assessed before and after each visit.

Acute Effect of Chromatic Environment During Chemotherapy

Acute Effect of Chromatic Environment During Chemotherapy Sessions on Health Status and Pain

The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension.

The EQ VAS is an independent subscale of the EUROQOL-5D-5L questionnaire, which uses a vertical visual analogue scale format. The EQ VAS is used for recording the self-rated health on a range from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement

Per standard of care, in beats per minute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Elders Preferences in Care Decisions	NCT01575990	Early Detection... Colon Cancer Decision Making Patient-Centere...	Making A Decisi... Drivers 65 Plus	70 Years - 84 Years	University of North Carolina, Chapel Hill
Elders Preferences in Care Decisions	NCT01575990	Early Detection... Colon Cancer Decision Making Patient-Centere...	Making A Decisi... Drivers 65 Plus	70 Years - 84 Years	University of North Carolina, Chapel Hill
Comparing Aerobic to Resistance Training in Recovery From Cancer	NCT00237926	Neoplasms	Exercise	18 Years -	Brooke Army Medical Center
A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms	NCT02842229	Myelodysplastic... Leukemia Myeloi... Multiple Myelom... Leukemia, Lymph...		65 Years -	Celgene
Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies	NCT02164071	Myelodysplastic... Leukemia Myeloi... Multiple Myelom... Leuklemia, Lymp...	Geriatric Asses...	65 Years -	Celgene
Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies	NCT02164071	Myelodysplastic... Leukemia Myeloi... Multiple Myelom... Leuklemia, Lymp...	Geriatric Asses...	65 Years -	Celgene
Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors	NCT00001301	Lymphoma, Non-H...		-	National Institutes of Health Clinical Center (CC)
A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms	NCT02842229	Myelodysplastic... Leukemia Myeloi... Multiple Myelom... Leukemia, Lymph...		65 Years -	Celgene
Acute Effect of Chromatic Environment During Chemotherapy	NCT03873519	Breast Cancer	Chromatic Envir... Room Orientatio...	18 Years - 89 Years	Universidad Europea de Madrid
A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms	NCT02842229	Myelodysplastic... Leukemia Myeloi... Multiple Myelom... Leukemia, Lymph...		65 Years -	Celgene

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