Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Lymphoid

Multiple Myeloma

Neoplasms, Plasma Cell

Chronic Disease

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Multiple Chronic Conditions

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, B-Cell

Disease Attributes

Myeloproliferative Disorders

Bone Marrow Diseases

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and community pharmacists.

Participants will complete a patient-reported outcome measure for their oral anticancer agent at two timepoints over 2 months, to assess patient symptoms and adherence to their oral anticancer agent.

Patient-reported outcome measure

Following the first patient-reported outcome measure, participants will be contacted by the community pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. A follow-up CMR will take place after the second patient-reported outcome measure.

Comprehensive Medication Review

Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.

Pharmacist communication

Justin Gatwood, PhD

Katie Gatwood, PharmD

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care or community practices (Pharmacists Coordinated care Oncology Model \[PCOM\]).

This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.

Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence

PDC is a common medication adherence metric, and assesses the ratio of number of days the patient is supplied with oral anticancer agent, from the time of initiation until 6 months later, to the total number of days during that period. Data from the electronic medical record for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.

PDCs for medications for select chronic diseases will be calculated for the 6 months before and after oral anticancer agent initiation

The oncology-specific patient-reported outcome measure is to be completed at 2 and 6 weeks after oral anticancer agent initiation. This measure assesses the percent of patients who complete this tool at both time points.

Proportion of enrolled subjects completing the initial and follow-up CMRs with the community pharmacist

The patient-reported outcome measure is scored within one day after it is completed by the subject and is routed to the oncology pharmacist to review the results. The number of measures that are reviewed within 1 day of receipt will be assessed at 2 weeks and at 6 weeks.

The number of CMRs where note was routed to oncology pharmacist out of total number of completed CMRs, assessed at 2 weeks and at 6 weeks.

The number of CMR notes reviewed by the oncology pharmacist out of the total number of completed CMRs, assessed at 2 weeks and at 6 weeks.

Vanderbilt University Medical Center

AstraZeneca

University of Tennessee

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Diabetes Mellitus

Hypertension

Tailored Technology-Enhance Home-based exercise program (iHBE)

Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care

The tailored technology enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 5 home visits and 7 phone follow ups during exercise. The technologies, a wearable device, and a smartphone application, will be used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, send daily reminding message through Mobile Ecological Momentary Assessment (mEMA). The coded raw data without personal identification information from the wearable device will be sent to the servers where the investigators can store it in the database alongside the mEMA data and create custom reports showing Heart Rate (HR) 30 minute before each Ecological Momentary Assessment (EMA) survey, showing HR and previous self-report responses before/ after each automatically triggered EMA.

Nada Lukkahatai, PhD

A home-based, tailored, technology-enhanced home-based exercise program (iHBE) using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise will be pilot tested. Participants will choose one of the four home-based exercise options \[National Institute of Aging (NIA) Go4Life (an exercise and physical activity campaign from the NIA), Iyengar-style yoga, walking, and modified Otago exercise\] based on participants' preference and goals. The integrated mobile technologies system will allow the investigators to extract heart rate data directly from the wearable device to the research server. This data will be used to provide appropriate and personalized feedback on physical performance. The survey and notification to the participants on the smartphone.

The benefits of physical activity on managing chronic illnesses and multiple symptoms are well established. However, increasing the physical activity of persons living with Multiple Chronic Conditions (MCC), especially low -income cancer survivors with MCC, is challenging. Home-based exercise improves physical activity and symptoms among persons with the single chronic disease. One major challenge of the home-based exercise is the motivation and adherence. The mobile technologies (e.g., wearable device and smartphone application) have been used to improve motivation and monitor a person physical activity. Guided by the society to cells framework and previous preliminary findings, the investigators developed a technology-enhanced home-based exercise program using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise. Participants will choose one of the four home-based exercise options \[National Institute of Aging (NIA) Go4Life, Iyengar-style yoga, walking, and modified Otago exercise\] based on participants' preference and goals. The integrated mobile technologies system will allow the investigators to extract heart rate data directly from the wearable device to the research server. This data will be used to provide appropriate and personalized feedback on physical performance and trigger algorithms to send the survey and notification to the participants in real time. This pilot project will examine the feasibility of this technology-enhanced home exercise tailored to participants' goals and preferences. The intervention will leverage the cancer survivorship phase (post-treatment) to motivate self-care by combining tailored existing evidence-based physical activity programs and mobile technology for participants to engage in the resilience-enhancing physical activity. Identification of BDNF's role as one of the exercise outcomes provide a novel target for an intervention and increase the investigators' understanding of the underlying mechanism of symptoms and resilience. This study aims to examine the feasibility and acceptability of the iHBE program among low-income cancer survivors living with co-morbid conditions. Eight participants who have completed treatment for a solid tumor cancer with at least one comorbidity (e.g., diabetes and/or hypertension) will be assigned to an open-label trial of the idea. The investigators will gather feedback on goal setting, problem-solving strategies, exercise choices, and tracking mechanisms, program feasibility, and acceptability and modify the intervention as needed.

This is a two-arm parallel assignment involving two groups of participants. One group receives exercise intervention, and the other group receives usual care (control group).

Single blinded marking: The data collectors are blinded to the group allocation

Tailored Home-Based Exercise Program for Multiple Chronic Conditions

Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions

The individual participant data (IPD) will not be shared with other researchers

Patient-Reported Outcomes Measures Information System (PROMIS) Short Form V1.0-Fatigue 6a. A 6-items; self-reported fatigue (frequency, duration, intensity) and the impact on physical, mental, and social activities, has five response options (1 or never to 5 or always). The overall score range from 6 (no fatigue) to 30 (extreme fatigue). Higher score means a greater fatigue

Connor-Davidson Resilience scale: 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience). The higher score means a better resilience

Physical well being as assessed by 36 item self-report instrument. The overall score derived from the physical functioning, role limitation-physical, and bodily pain domains. The overall score range from 0-400, with a score 400 reflecting the highest rating of physical health.

Mental component of the Short Form Survey (SF-36), the 36 item self-report instrument. The overall score was derived from the mental health, and role limitation-emotional domains. The total score range from 0 to 200, with a score of 200 indicating high mental well being

The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.

The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.

Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.

National Institute of Nursing Research (NINR)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.

The iHBE Program Group

Usual Care (Control Group)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

PROMIS Short Form V1.0-Fatigue 6a 6-items; self-reported fatigue (frequency, duration, intensity) and the impact to physical, mental, and social activities, has five response options (1 or never to 5 or always).

Fatigue

Resilience is measured by Connor-Davidson Resilience Scale. A 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time)

Resilience

The physical component of the Short Form survey (SF-36). 36-item self-report instrument measures 2 domains: physical well-being and affective well-being

Physical well-being

The mental component of the Short Form Survey (SF-36). 36-item self-report instrument measures 2 domains: physical well-being and affective well-being

Mental well-being

Nada Lukkahatai

Change in Fatigue as Assessed by Self-reported Fatigue Questionnaire

Change in Resilience as Assessed by Connor-Davidson Resilience Scale

Change in Physical Well Being

Change in Mental Well Being

Physical Activity

Due to the pandemic interruption with in-person research activity, we were unable to collect blood and sweat samples from the participants. Therefore, no data is available for this outcome.

Change in Brain-Derived Neurotrophic Factor Level (in Serum)

Tailored Technology-Enhance Home-based exercise program (iHBE)

Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 5 home visits and 7 phone follow ups during exercise. The technologies, a wearable device, and a smartphone application, will be used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, send daily reminding message through Mobile Ecological Momentary Assessment (mEMA). The coded raw data without personal identification information from the wearable device will be sent to the servers where the investigators can store it in the database alongside the mEMA data and create custom reports showing Heart Rate (HR) 30 minute before each Ecological Momentary Assessment (EMA) survey, showing HR and previous self-report responses before/ after each automatically triggered EMA.

Change in Brain-Derived Neurotrophic Factor Level (in Sweat)

Overall Study

The Pharmacist Coordinated care Oncology Model includes patient self-reported symptoms and medication adherence, comprehensive medication review(s) and intentional communication between oncology and primary care pharmacists.

Participants will complete a PROM (Michigan Oncology Quality Consortium, Patient Assessment Tool for Oral Chemotherapy) for their oral anticancer agent (OAA) at two timepoints over 2 months, to assess patient symptoms and adherence to OAA.

Patient Reported Outcome Measure (PROM)

Following the first PROM, participants will be contacted by the primary care pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. If warranted, a follow-up CMR will take place after the second PROM.

Comprehensive Medication Review (CMR)

Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.

Communications between oncology and primary care pharmacists

Karen Farris, PhD

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care practices (Pharmacists Coordinated care Oncology Model \[PCOM\]).

This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.

Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications

Implementation of a Model Integrating Primary and Oncology Care for Patients Taking Oral Anticancer Agents (OAA)

PDC is a common way to assess a patient's adherence to a medication regimen. PDC is the ratio of number of days the patient is supplied with OAA medication, from the time of OAA initiation until 6 months later, to the total number of days during that period. For OAAs, data from the electronic medical record (EMR) for dose changes will be aligned with the refill data to calculate a dose-adjusted PDC.

PDC is the ratio of the number of days the patient is supplied with chronic condition medications, from the time of OAA initiation until 6 months later, to the total number of days during that period.

The Michigan Oncology Quality Consortium (MOQC) OAA PROM, Patient Assessment Tool for Oral Chemotherapy is to be completed at 2 and 6 weeks after OAA initiation. This measure assesses the percent of patients who complete this PROM at both time points.

Completed CMR includes initial and follow-up CMR with primary care pharmacist.

The PROM is scored within one day after it is completed by the patient. The primary care pharmacist sets a date and time for the initial CMR after receiving the first scored PROM.

The PROM is scored within one day after it is completed by the patient and is routed to the oncology pharmacist to review the results. The number of PROMs that are reviewed within 1 day of receipt will be assessed at 2 weeks and at 6 weeks.

The number of CMR where note was routed to oncology pharmacist out of total number of completed CMRs, assessed at 2 weeks and at 6 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence	NCT04663100	Chronic Myeloid... Chronic Lymphoc... Multiple Myelom... Multiple Chroni...	Patient-reporte... Comprehensive M... Pharmacist comm...	18 Years -	University of Tennessee
Tailored Home-Based Exercise Program for Multiple Chronic Conditions	NCT03874754	Cancer Hypertension Diabetes	Tailored Techno...	21 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Tailored Home-Based Exercise Program for Multiple Chronic Conditions	NCT03874754	Cancer Hypertension Diabetes	Tailored Techno...	21 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications	NCT04595851	Chronic Myeloid... Chronic Lymphoc... Multiple Chroni...	Patient Reporte... Comprehensive M... Communications ...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for multiple chronic conditions