Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Myeloproliferative Disorders

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Patients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week.

Complete online audio-based mindfulness meditation exercises

Online Mindfulness Meditation

Internet-Based Webinars

Kelly Schoenbeck, MD

This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Mindfulness meditation is the practice of repeatedly bringing attention back to the immediate experience and may help people cope with various types of illness, stress, and worry. This may help patients and caregivers to gradually learn to disconnect from reacting to and dwelling on the past and future and instead fully experiencing the present moment.

PRIMARY OBJECTIVES:

I. To tailor the Being Present intervention to BCR-ABL-negative MPN and CP-CML patients.

II. To determine the feasibility of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on tyrosine kinase inhibitors (TKIs), and CP-CML patients in treatment-free remission (TFR).

III. To determine the acceptability of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, CP-CML patients on TKIs, CP-CML patients on TKIs, and CP-CML patients in TFR.

SECONDARY OBJECTIVE:

I. To evaluate the preliminary efficacy of the intervention.

EXPLORATORY OBJECTIVES:

I. To evaluate for differences in the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars:

Ia. Based on demographic or clinicopathologic factors. Ib. In patients versus caregivers.

II. To evaluate for differences in the preliminary efficacy an 8-week web-based mindfulness meditation program with live webinars:

IIa. Based on demographic or clinicopathologic factors. IIb. In BCR-ABL-negative patients versus caregivers. IIc. In BCR-ABL-negative patient-caregiver pairs versus unpaired patients. IId. Based on level of adherence to the practice instructions.

OUTLINE:

Patients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week.

After completion of study, patients and caregivers are followed up at 8 weeks.

A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors

Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors

The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.

The frequency and categorization of participants' understanding of hematologic malignancies will be assessed by semi-structured qualitative interviews.

The frequency and categorization of participants' perception of web-based mediation will be assessed by semi-structured qualitative interviews.

The frequency and categorization of participants' reported barriers to web-based mediation will be assessed by semi-structured qualitative interviews.

Recruitment rate will be reported as a percentage of all patients who were approached by the study team or medical professional whom consented to participate in the active study.

For potential study candidates who are ineligible, caregiver relationship and reasons for ineligibility will be collected. Reasons for ineligibility will be reported using descriptive statistics.

For potential study candidates who decide not to participate, caregiver relationship and reasons for refusal will be collected. Reasons for refusal will be reported using descriptive statistics.

The number of participants who attend the web-based sessions will be recorded via a roll-call and recorded at each study visit.

Reasons for not attending the web-based interventions will be recorded and characterized. Reasons for attrition will be reported using descriptive statistics.

The study team will call participants and conduct a brief interview to gauge current mindfulness meditation practice. Frequency of mediation will be reported using descriptive statistics.

The study team will call participants and conduct a brief interview to gauge current duration of mindfulness meditation practice. Duration of mediation will be reported using descriptive statistics.

The frequency in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics

The duration in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics

Information about acceptability and the overall intervention experience will come from semi-structured interviews. Audio recordings of the semi-structured interviews will be professionally transcribed and coded using Atlas.ti for categorizing acceptability using qualitative thematic analysis by at least two investigators.

This single-item inventory uses an analog graphic to allow patients to assess their overall distress with a score range of 0 (no distress) to 10 (extreme distress). A score of 4 or higher to differentiate clinically significant distress. Paired t-tests will compare validated survey results.

The PROMIS anxiety scale is a 8 item scale which measures a participants anxiety based on their response to anxiety related items. Each item response ranges from 1 (never) to 5 (always)Paired t-tests will compare validated survey results. Raw scores ranging from 8 - 40 are converted to scaled scores to determine a standardized anxiety score with higher scores indicating a greater anxiety. Paired t-tests will compare validated survey results.

The EORTC QLQ-C30 has been developed as a quantitative measure of health-related quality of life for use in clinical trials of cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Paired t-tests will compare validated survey results.

The MPN-SAF TSS is 10-item questionnaire is recommended in the NCCN Guidelines for the assessment of symptom burden at baseline and monitoring symptom status during the course of treatment with individual item scores ranging from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity. Paired t-tests will compare validated survey results.

The EORTC QLQ-CML24 assessment consists of 24 items measuring the following aspects: Symptom Burden, Impact on Daily Life, Impact on Worry/Mood, Body Image Problems, Satisfaction with Care and Satisfaction with Social Life. This scale includes 24 items with responses ranging from a score of 0 (not at all) to 4 (very much). Paired t-tests will compare validated survey results.

The CQOLC is a self-administered scale specifically designed to evaluate cancer patient caregiver quality of life. This scale includes 35 items with responses ranging from a score of 0 (not at all) to 4 (very much). The total possible score is 140, with higher scores representing better quality of life. Paired t-tests will compare validated survey results.

The FFMQ-SF assessment measures five facets of mindfulness: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Non-Reactivity to inner experience. The score of each facet is computed by summing the 3 items assigned to the facet which asks the individual to rate which response represents your own opinion of what is generally true for you. Each statement (item) has scores ranging from 1 (never or very rarely true) to 5 (very often or always true), for a total of 15 points per facet. Paired t-tests will compare validated survey results.

American Society of Hematology

University of California, San Francisco

Behaviors and Mental Disorders

Digestive System Diseases

Anxiety Disorders

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients receive usual care prior to their scheduled screening colonoscopy.

Patients receive an online mindfulness intervention including infographics and 5-minute meditations QD for 5 days prior to their scheduled screening colonoscopy.

Best Practice

Medical Chart Review

Receive an online mindfulness intervention

Survey Administration

Mira Katz

This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.

PRIMARY OBJECTIVE:

I. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive usual care prior to their scheduled screening colonoscopy.

GROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy.

After completion of study intervention, patients are followed up 1-2 days post-colonoscopy.

Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy

A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial

Feasibility will be assessed by the number of patients referred, number of participants recruited, and missing data from surveys and medical records. Feasibility will be achieved with a retention rate of 90% throughout the intervention. An independent samples t-test will be conducted to compare State-Trait Anxiety Inventory: State-Subscale (STAI-S) scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.

Acceptability will be assessed by the number of intervention materials accessed and time to complete study activities (infographics, meditations, and surveys) via embedded REDCap metrics. Participants within the MBI group will also report meditation satisfaction and state mindfulness immediately after each meditation in addition to intervention satisfaction during the follow-up survey. Will report an average satisfaction score with the intervention \>= 6.0, measured using a 7-point Likert scale. An independent samples t-test will be conducted to compare STAI-S scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.

Anxiety specific to the bowel prep and colonoscopy will be assessed using a visual analogue scale. Will be analyzed using t-test.

Will measure the trait mindfulness using The Philadelphia Mindfulness Scale, a 20-item self-report with subscales of awareness and acceptance. Will be analyzed using t-test.

Will be assessed using a 5-item score about mindfulness. An independent samples t-test will be conducted to compare STAI-S scores.

Will be assessed using a 5-item score about colorectal (CRC) screening. Will be analyzed using t-test.

Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using chi-square test.

Will be measured using the Boston Bowel Preparation Scale or 5-point Likert scale and medical chart review. Will be analyzed using t-test.

Will be measured by attendance. Will be analyzed using chi-square test.

Will be measured in beats per minute using medical chart review. Will be analyzed using t-test.

Will be measured in millimeter of mercury using chart review at time of check-in (the first recorded) to the endoscopy suite holding area. Will be analyzed using t-test.

Will be measured in milligrams using chart review. Will be analyzed using t-test.

Will be measured in minutes using medical chart review. Will be analyzed using t-test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors	NCT04605211	Myeloproliferat... Chronic Phase C... Chronic Myeloid...	Online Mindfuln... Internet-Based ...	18 Years -	University of California, San Francisco
Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy	NCT06233253	Colorectal Carc...	Best Practice Medical Chart R... Online Mindfuln... Survey Administ...	45 Years - 75 Years	Ohio State University Comprehensive Cancer Center

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