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Prostate CancerNCT03853902

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

A study testing Mindfulness Program in people with Prostate Cancer, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Mindfulness Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
26 Jan 2016to 23 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: MOSAIC-P: Mindfulness Online for Symptom Alleviation and Improvement in Cancer of the Prostate

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.

Read the detailed description

Participants will be recruited from multiple locations, including NorthShore University Health System's Kellogg Cancer Center (KCC) and local community organizations (e.g., UsToo meetings, Cancer Wellness Center). Participating physician researchers will identify their eligible patients from the electronic medical record and will mail them a letter of invitation to learn more about the study and consider enrolling. Each participant will be e-mailed a link to the baseline questionnaire. After baseline completion, participants will be randomized, using an online random number generator, to the online course or face-to-face course. Course orientation for both groups will be held on the same night, but at different times. The separate orientations will be scheduled with a thirty minute break in between, in order to prevent intermixing of the groups and potential dissatisfaction among participants about their assigned group. In the orientation for the online class, participants will become familiar with the online video conferencing program Zoom, be introduced to other group participants, and receive a clear overview of what to expect for the 4-week mindfulness course. In the orientation for the face-to-face class, participants will be introduced to other group participants and receive a clear overview of what to expect for the 4-week mindfulness course. Participants will meet for approximately 2.5 hours each week for 4 weeks online or face-to-face. In addition, a face to face half day retreat will occur after the third class, in which participants from both face to face and online courses may attend. In the event that a participant unexpectedly misses a class, the instructor will follow-up with them and review the material covered in class. The class instructor may contact participants up to 3 times to review class expectations and teachings prior to or during the 4-week program. Participants will once again be asked to complete the online assessment.

Conditions
Prostate Cancer
Being tested
Mindfulness Program
Keywords
prostate cancer, mindfulness, MBSR, online course
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness ProgramBehavioural

    Mindfulness Program

Study groups in NCT03853902
Study groupRoleWhat they receive
Mindfulness Program OnlineExperimentalOnline 4-week mindfulness program that is intended to reduce stress and improve the quality of life of patients with metastatic prostate cancer
Receives: Behavioral: Mindfulness Program
Mindfulness Program Face-to-FaceActive comparatorIn-person 4-week mindfulness program that is intended to reduce stress and improve the quality of life of patients with metastatic prostate cancer
Receives: Behavioral: Mindfulness Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, week 4

  2. 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.

    Measured: baseline, week 4

  3. 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.

    Measured: baseline, week 4

  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.

    Measured: baseline, week 4

  5. 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.

    Measured: baseline, week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2019
  2. Study start26 Jan 2016
  3. Primary completion23 Nov 2018
  4. Study completion23 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into a mindfulness course online or a mindfulness course in-person
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03853902
Sponsor's protocol ID
EH15-403
Status last verified
May 2023
First submitted
12 Dec 2018
Last updated
11 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Society AC. American Cancer Society Cancer Facts & Figures. Atlanta: American Cancer Society; 2014

  • Resnick MJ, Penson DF. Quality of life with advanced metastatic prostate cancer. Urol Clin North Am. 2012 Nov;39(4):505-15. doi: 10.1016/j.ucl.2012.07.007. Epub 2012 Aug 27.

    PubMed 23084527

  • Sartor O, Flood E, Beusterien K, Park J, Webb I, MacLean D, Wong BJ, Mark Lin H. Health-related quality of life in advanced prostate cancer and its treatments: biochemical failure and metastatic disease populations. Clin Genitourin Cancer. 2015 Apr;13(2):101-12. doi: 10.1016/j.clgc.2014.08.001. Epub 2014 Aug 19.

    PubMed 25262852

  • Lengacher CA, Johnson-Mallard V, Barta M, Fitzgerald S, Moscoso MS, Post-White J, Jacobsen PB, Molinari Shelton M, Le N, Budhrani P, Goodman M, Kip KE. Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. J Holist Nurs. 2011 Jun;29(2):107-17. doi: 10.1177/0898010110385938. Epub 2010 Nov 1.

    PubMed 21041554

  • Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529.

    PubMed 19235193

  • Gross CR, Kreitzer MJ, Reilly-Spong M, Wall M, Winbush NY, Patterson R, Mahowald M, Cramer-Bornemann M. Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial. Explore (NY). 2011 Mar-Apr;7(2):76-87. doi: 10.1016/j.explore.2010.12.003.

    PubMed 21397868

  • Bishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004 2004;11(3):230-241

  • Hulsheger UR, Alberts HJ, Feinholdt A, Lang JW. Benefits of mindfulness at work: the role of mindfulness in emotion regulation, emotional exhaustion, and job satisfaction. J Appl Psychol. 2013 Mar;98(2):310-25. doi: 10.1037/a0031313. Epub 2012 Dec 31.

    PubMed 23276118

  • Kabat-Zinn J. Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing; 1990

  • Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003 Jul-Aug;65(4):571-81. doi: 10.1097/01.psy.0000074003.35911.41.

    PubMed 12883107

  • Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74. doi: 10.1016/s0306-4530(03)00054-4.

    PubMed 14749092

  • Saxe GA, Major JM, Nguyen JY, Freeman KM, Downs TM, Salem CE. Potential attenuation of disease progression in recurrent prostate cancer with plant-based diet and stress reduction. Integr Cancer Ther. 2006 Sep;5(3):206-13. doi: 10.1177/1534735406292042.

    PubMed 16880425

  • Victorson D, Du H, Hankin V, et al. MINDFULNESS BASED STRESS REDUCTION DECREASES FEAR OF PROGRESSION OVER TIME FOR MEN WITH PROSTATE CANCER ON ACTIVE SURVEILLANCE: RESULTS FROM A RANDOMIZED CLINICAL TRIAL. The Journal of Urology. 2012 2012;187(4S):384

  • Zernicke KA, Campbell TS, Speca M, McCabe-Ruff K, Flowers S, Dirkse DA, Carlson LE. The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial. BMC Complement Altern Med. 2013 Feb 16;13:34. doi: 10.1186/1472-6882-13-34.

    PubMed 23414206

  • Cavanagh K, Strauss C, Cicconi F, Griffiths N, Wyper A, Jones F. A randomised controlled trial of a brief online mindfulness-based intervention. Behav Res Ther. 2013 Sep;51(9):573-8. doi: 10.1016/j.brat.2013.06.003. Epub 2013 Jun 28.

    PubMed 23872699

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Program in people with Prostate Cancer, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain interference using the PROMIS Pain Interference questionnaire (time frame: baseline, week 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03853902, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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