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

Status: complete

This clinical 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.

Inclusion Criteria

PATIENT: Carry a diagnosis of BCR-ABL-negative MPN or CML
PATIENT: CML patients must be actively treated with a TKI during the study period
PATIENT: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
PATIENT: Be able to speak and read English
PATIENT: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
PATIENT: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
PATIENT: Be age >= 18 years old
PATIENT: Be able to provide informed consent
CAREGIVER: Be a spouse/partner, other family member, or a close friend of a BCR-ABL-negative patient who consented to participate in the Being Present-MPN study
CAREGIVER: Be able to speak and read English
CAREGIVER: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
CAREGIVER: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
CAREGIVER: Be age >= 18 years old
CAREGIVER: Be able to provide informed consent

Exclusion Criteria

PATIENT: Have had their BCR-ABL-negative MPN transform into acute leukemia
PATIENT: Have had their CP-CML transform into blast phase
PATIENT: Be post-allogeneic stem cell transplantation
PATIENT AND CAREGIVER: Have extensive hearing loss such that ability to participate in the study would be impaired

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, CP-CML patients on 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, 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 over 8 weeks 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 once weekly.

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

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

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