Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).

Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or PCM. During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers.

Best Practice

Educational Intervention

Questionnaire Administration

Electronic Health Record Review

Attend video or phone calls with a CHW and/or PCM

Health Telemonitoring

Receive personalized pain management plan

Cancer Pain Management

Clinical Trials Referral Office

Jessica D. Austin, Ph.D.

Josiah Lulf

Andrea L. Cheville, M.D.

This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially well matched for these patients, and can be customized to address their needs. The ASCENT intervention provides patients with an educational guide that describes techniques for addressing cancer pain, and uses community health workers and pain care managers to coach patients through a personalized pain management plan. This study may help researchers learn how pain management strategies can improve cancer pain and lower risk of opioid exposure and dependency in rural and Hispanic cancer survivors.

PRIMARY OBJECTIVE:

I. To test a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors by promoting multimodal pain care (MMPC) to reduce inappropriate opioid use and by addressing social determinants of health (SDOH) that impede a patient's access to appropriate care.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).

ARM II: Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their community health worker (CHW) and/or pain care manager (PCM). During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers.

Patient Reported Outcome Measures will be administered at baseline by a study coordinator and at 3 and 6 months by a blinded, bilingual, assessor.

A Collaborative Pain Management Intervention for Improving Cancer Pain Management in Rural and Hispanic Cancer Survivors

Achieving Equity Through Socioculturally-Informed, Digitally-Enabled Cancer Pain Management (ASCENT) - Main Trial

Will be measured using the Brief Pain Inventory Short Form (BPI SF), a 4-item questionnaire answered on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates worse pain.

Will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF) 6b, a 6-item questionnaire that measures the effects of pain on physical functioning over the past 7 days. Questions are answered on a scale of 1-5, with higher scores indicating more pain interference.

Will be measured using the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) questionnaire, which measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each component has three response levels of severity: no problems, some problems, extreme problems.

Will be measured using the Patient Health Questionnaire-2 (PHQ-2), a two-item questionnaire answered with responses from 0 (not al all) to 3 (nearly every day). A higher score indicates a higher level of depression.

Will be measured using the Generalized Anxiety Disorder-2 (GAD-2) scale, a two-item questionnaire answered with a score of 0 (not at all) to 3 (nearly every day). A higher score indicates higher frequency of being bothered by anxiety.

Will be measured using the PROMIS Sleep Disturbance 6a, a 6-item questionnaire assessing sleep disturbance over the past 7 days. Each question is answered with a score of 1-5, with a higher score indicating greater sleep disturbance.

Will be measured using logged count data.

Will be measured in minutes/week that participants access available electronic tools.

Will be measured using the PROMIS SF 4a, a six-item questionnaire with each question answered on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate greater perceived social isolation.

Will be measured in oral morphine equivalents and collected using electronic health record (EHR) prescriptions.

Will be measured by reviewing the electronic health record (EHR) and administrative billing data for incidents of hospitalization and emergency department visits

National Cancer Institute (NCI)

Mayo Clinic

Neoplasms

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.

Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion.

Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.

Health Promotion and Education

Interview

Receive healthcare provider follow ups as part of the CONCURxP program

Patient Navigation

Survey Administration

Receive personalized text message reminders related to their medication tracking as part of the CONCURxP program

Text Message-Based Navigation Intervention

Site Public Contact

Jay W. Carlson

Gelareh Sadigh

Ilana Graetz

John M. Schallenkamp

Maria T. Grosse-Perdekamp

Joseph J. Merchant

Deborah W. Wilbur

Pamala A. Pawloski

Charissa K. Williams

This clinical trial compares the use of the connected customized treatment platform (CONCURxP), consisting of using a medication monitoring device called WiseBag along with text message reminders for missed or extra medication events, to enhanced usual care (EUC), where patients only use the WiseBag, to monitor medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor. To ensure CDK4/6 inhibitors achieve their full clinical benefit, patients need to take them as prescribed, following a complex treatment schedule. Forgetfulness was the most common reason reported for medication non adherence. Using the WiseBag along with CONCURxP or enhanced usual care may improve medication adherence in patients with metastatic breast cancer who are taking a CKD4/6 inhibitor.

PRIMARY OBJECTIVE:

I. To compare CDK4/6 inhibitors (CDK4/6i) adherence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.

SECONDARY OBJECTIVES:

I. To compare CDK4/6i adherence at 12 months after completion of the baseline survey captured through self-report between the EUC (Arm A) and CONCURxP (Arm B) arms.

II. To compare CDK4/6i persistence at 12 months after completion of the baseline survey captured using electronic monitoring between the EUC (Arm A) and CONCURxP (Arm B) arms.

III. To compare symptom burden at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

IV. To compare quality of life at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

V. To compare patient-provider communication at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

VI. To compare self-efficacy for managing symptoms at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

VII. To compare financial worry at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

EXPLORATORY OBJECTIVES:

I. To assess longitudinal changes of patient-reported outcomes (self reported adherence, symptom burden, quality of life, and financial worry) from the EUC (Arm A) and CONCURxP (Arm B) arms.

II. To compare healthcare utilization at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

III. To compare progression-free survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

IV. To compare overall survival at 12 months between the EUC (Arm A) and CONCURxP (Arm B) arms.

V. To describe CONCURxP (Arm B) patients and their provider experience with various implementation outcomes.

OUTLINE: Patients are randomized into 1 of 2 arms. Non-patient participants are assigned to arm C.

ARM A: Patients use the WiseBag medication dispenser and receive access to educational materials every 4 weeks over 12 months.

ARM B: Patients use the WiseBag medication dispenser and receive personalized text message reminders, medication tracking and healthcare provider follow ups as part of the CONCURxP platform over 12 months. Patients may complete an interview over 20-30 minutes within 6 months of study completion.

ARM C: Participants complete an interview over 20-30 minutes 15-39 months post-first patient enrollment.

After completion of study intervention, patients may be followed up to 6 months.

Mobile Health for Adherence in Breast Cancer Patients

Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP)

Generalized estimating equation will be used to assess the longitudinal change over time.

The difference of healthcare utilization between two arms will first be evaluated using the two sample t test for the continuous variables (e.g., length of stay or number of emergency department visits), and then be modeled through the regressions to allow for the control of other covariates if needed.

Kaplan-Meier curves and log-rank testing will be used to visualize and compare progression free survival between the connected customized treatment platform (CONCURxP) patient group and enhanced usual care group, and Cox proportional hazards model will be fit to evaluate the impact of potential moderators on the associations of progression-free survival with arms.

Kaplan-Meier curves and log-rank testing will be used to visualize and compare overall survival between the CONCURxP patient group and enhanced usual care group, and Cox proportional hazards model will be fit to evaluate the impact of potential moderators on the associations of overall survival with arms.

We will measure portal usability using patient-reported survey and will report mean and SD. For qualitative interviews, we will use conventional content analysis methods.

Cox proportional hazards model will be fit to evaluate the impact of potential moderators (e.g., sociodemographic, insurance, cancer variables, endocrine therapy adherence, health literacy, health belief, medical history and NCORP practice characteristics.

For each arm, mean and standard deviation (SD) adherence rates for all patients will be calculated. A two-sample t-test will be used to compare CDK4/6 inhibitor (CDK4/6i) adherence between the two arms at 12 months.

Using the12-item Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.

Defined as duration from CDK4/6i initiation to discontinuation of medication against medical advice, measured as the number of days from initiation until the first day of a gap that is 30 days or longer. For each arm, mean days of persistence, and the proportion of patients who discontinue the medication earlier than 12-month will be calculated and compared between the two arms using the two-sample t-test and chi-squared test, respectively.

Using the 16-item National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.

Using the PROMIS-10- version (v)1.2-Global Health compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.

Using the Consumer Assessment of Healthcare Providers and Systems compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.

Using PROMIS Item Bank v1.0 - Self-Efficacy for Managing Symptoms compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.

Using the Comprehensive Score for Financial Toxicity compare mean score and changes in mean scores (from baseline) at each time point between the arms using two-sample t-tests.

ECOG-ACRIN Cancer Research Group

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Patients receive standard outpatient supportive care after completion of chemotherapy.

Patients receive standard outpatient supportive care as in Arm I and use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to 3-4 weeks).

Quality-of-Life Assessment

Receive standard outpatient supportive care

Supportive Care

Anna Halpern

This randomized pilot clinical trial studies a home telemonitoring device in managing the care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are discharged from the hospital following chemotherapy. After treatment and hospital discharge, patients typically need extensive care to deal with the side effects of chemotherapy, keep up with medications, and obtain medical assistance. A home telemonitoring device would allow patients to monitor vital signs, symptoms, and use of medications, communicate with healthcare providers, and access educational material. A telemonitoring device may allow patients to be managed more effectively than standard outpatient care after being discharged from the hospital.

PRIMARY OBJECTIVES:

I. To determine the feasibility of home telemonitoring for adult patients following intensive induction, re-induction/salvage, or consolidation chemotherapy for myelodysplastic syndrome (MDS) or non-acute promyelocytic leukemia (APL) acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. To estimate the impact of the telemonitoring intervention on mortality, duration of hospital stay, use of emergency services, visits to primary care physicians and to specialists, home visits, and telephone calls ("health care resource utilization").

II. To evaluate the telemonitoring procedure in economic terms compared to usual care through a cost-effectiveness analysis.

III. To estimate the impact on the quality of life of study participating.

IV. To assess the degree of satisfaction of the patients/caregivers and health care professionals with the telemonitoring intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (CONTROL): Patients receive standard outpatient supportive care after completion of chemotherapy.

ARM II (INTERVENTION): Patients receive standard outpatient supportive care as in Arm I and use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to 3-4 weeks).

Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy

Integrating a Telemonitoring Device Into the Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML: A Randomized Pilot Study

Exploratory, descriptive and observational methods will be used to determine enrollment and retention issues in AML/MDS patients who are discharged early after intensive chemotherapy.

Exploratory, descriptive, and observational methods will be used to determine the ability to remotely monitor this patient population.

Researchers' ability to use the transmitted data to support patients in recognizing changes in their conditions and managing the changes or getting appropriate medical assistance will be estimated between study arms using exploratory, descriptive, and observational methods.

Exploratory, descriptive, and observational methods will be used to estimate differences between the study arms.

Exploratory, descriptive, and observational methods will be used to estimate in the impact of the telemonitoring intervention on QOL.

Percentage of returned surveys will be measured as a feasibility outcome.

The impact of the telemonitoring intervention on mortality compared to the control group will be estimated.

Descriptive and observational methods will be used to estimate the impact of the telemonitoring intervention with regard to health care resource utilization, and data on rehospitalization (frequency, duration, resource use, and need for intensive care unit-level care).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Collaborative Pain Management Intervention for Improving Cancer Pain Management in Rural and Hispanic Cancer Survivors	NCT06198010	Hematopoietic a... Malignant Solid...	Best Practice Educational Int... Questionnaire A... Electronic Heal... Health Telemoni... Cancer Pain Man...	18 Years -	Mayo Clinic
Mobile Health for Adherence in Breast Cancer Patients	NCT06112613	Anatomic Stage ... Breast Carcinom... HER2-Negative B... Hormone Recepto...	Electronic Heal... Health Promotio... Health Telemoni... Interview Patient Navigat... Survey Administ... Text Message-Ba...	18 Years -	Eastern Cooperative Oncology Group
Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy	NCT02226497	Acute Myeloid L... Myelodysplastic...	Health Telemoni... Quality-of-Life... Questionnaire A... Supportive Care	18 Years - 75 Years	Fred Hutchinson Cancer Center

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