Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate

NCT03853902 | Completed

• 1 other identifier: EH15-403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the researchers will examine the effects of a 4-week online mindfulness intervention, compared to a face-to-face mindfulness intervention, to reduce self-reported symptoms of fatigue, anxiety, depression, sleep disturbance, and pain interference in a sample of patients with metastatic prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate cancer; mindfulness; MBSR; online course

Outcome Measures

Primary Outcomes (5)

• Change in pain interference using the PROMIS Pain Interference questionnaire

  Participants were administered the PROMIS Pain Interference questionnaire. The PROMIS Pain Interference measures the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS Pain interference also incorporates items probing sleep and enjoyment in life, though it only contains one sleep item. The PROMIS Pain Interference is generic rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured.

  baseline, week 4

• Change in sleep using the PROMIS Sleep Disturbance questionnaire

  Participants were administered the PROMIS Sleep Disturbance questionnaire. The PROMIS Sleep Disturbance assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities. The PROMIS Sleep Disturbance is universal rather than disease-specific. It assesses sleep disturbance over the past seven days. Each question has five response options ranging in value from one to five (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured.

  baseline, week 4

• Change in depression using the PROMIS Depression questionnaire

  Participants were administered the PROMIS Depression questionnaire. The PROMIS Depression assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms are not included, which eliminates consideration of these items' confounding effects when assessing patients with co-morbid physical conditions. The PROMIS Depression is universal rather than disease-specific. It assesses depression over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured.

  baseline, week 4

• Change in anxiety using the PROMIS Anxiety questionnaire

  Participants were administered the PROMIS Anxiety questionnaire. The PROMIS Anxiety measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Only one behavioral avoidance item is included; therefore, behavioral fear avoidance is not fully evaluated. The PROMIS Anxiety is universal rather than disease-specific. It assesses anxiety over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured.

  baseline, week 4

• Change in fatigue using the PROMIS Fatigue questionnaire

  Participants were administered the PROMIS Fatigue questionnaire. The PROMIS Fatigue evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities.The PROMIS Fatigue is universal rather than disease-specific. It assesses fatigue over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. A higher score represents more of the concept being measured.

  baseline, week 4

Study Arms (2)

Mindfulness Program Online

EXPERIMENTAL

Online 4-week mindfulness program that is intended to reduce stress and improve the quality of life of patients with metastatic prostate cancer

Behavioral: Mindfulness Program

Mindfulness Program Face-to-Face

ACTIVE COMPARATOR

In-person 4-week mindfulness program that is intended to reduce stress and improve the quality of life of patients with metastatic prostate cancer

Behavioral: Mindfulness Program

Interventions

Mindfulness Program BEHAVIORAL

Mindfulness Program

Mindfulness Program Face-to-Face; Mindfulness Program Online

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically advanced prostate cancer (e.g., castrate-sensitive, metastatic \[clinical metastasis\], castrate-resistant, non-metastatic \[rising PSA on LHRH\], castrate-resistant, metastatic)
• Receiving some form of cancer treatment (e.g., androgen deprivation therapy, chemotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-217
• At least 18 years of age
• Able to speak, read and understand English
• Able to perform basic activities of daily living (as determined by referring physician)
• Cognitively intact and free of serious psychiatric illness (as determined by referring physician)
• Access to internet connection within a room where patient will not be interrupted. This room needs to have an open space of about 6ft by 5 ft to allow for gentle movement and stretching.
• Access to a laptop or desktop computer with a camera. In the event that a patient does not have access to a computer, but is committed to the course, a laptop will be lent to him from the Department of Medical Social Sciences at Northwestern University.
• Willing to commit to the online MBSR course
• Willing to complete pre- and post-test assessments
• Physically able to participate in gentle Hatha yoga postures that are geared towards cancer patient populations, as determined by referring physician or medical team member

You may not qualify if:

• Regular user of MBSR or a similar mind-body therapy, which is defined as ≥ 4 times a week for the past 2 weeks
• Men with a short life expectancy as determined by the referring oncologist

Sponsors & Collaborators

• Northwestern University: lead
• Endeavor Health: collaborator

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David E Victorson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which is the treatment group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into a mindfulness course online or a mindfulness course in-person

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: February 26, 2019
• Study Start: January 26, 2016
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)