Prostate CancerNCT03852030
Mind-Body Health in Uro-Oncology: Research Study
A study testing Text or email message in people with Prostate Cancer and Kidney Cancer, run by Northwestern University at 2 sites in United States.
Trial summary
In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses. 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, Kidney Cancer, Bladder Cancer
- What is being tested?
- Text or email message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Jul 2016
- 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
- Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer
- Spouses/significant others will only be included if their partners with cancer diagnoses will be participating
- 18 years old or older
- Proficient in comprehending spoken English. Proficient in reading and writing English.
Who cannot join
- Is not able to receive email or text messages
- History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated.
- Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised.
- Diminished cognitive skills as to render consent meaningless
- Physical debilitation such that study participation would not be feasible or would create undue hardship.
- Participation in the intervention arm of the preceding study, "Reducing Stress During Active Surveillance" EH09-202.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.
Read the detailed description
Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.
- Conditions
- Prostate Cancer, Kidney Cancer, Bladder Cancer
- Being tested
- Text or email message
- Keywords
- prostate cancer, mindfulness, eHealth, kidney cancer, bladder cancer, caregiver
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text or email messageBehavioural
Text or email messages sent to research participants
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness text/email message | Experimental | Weekly MBSR specific text or email messages related to course teachings were sent.
TYPES OF MESSAGES INCLUDED: Non-reaction; Non-Judgment; Awareness; Loving Kindness; Acceptance. Receives: Behavioral: Text or email message |
| Health promotion text/email message | Placebo comparator | Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress. Receives: Behavioral: Text or email message |
| No text/email message | No intervention | No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fatigue using the PROMIS Fatigue questionnaire
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
Measured: baseline, 8 weeks, 6 months, 12 months
change in depression using the PROMIS Depression questionnaire
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
Measured: baseline, 8 weeks, 6 months, 12 months
change in anxiety using the PROMIS Anxiety questionnaire
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
Measured: baseline, 8 weeks, 6 months, 12 months
change in sleep using the PROMIS Sleep Disturbance questionnaire
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
Measured: baseline, 8 weeks, 6 months, 12 months
change in physical function using the PROMIS Physical Function questionnaire
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
Measured: baseline, 8 weeks, 6 months, 12 months
change in stress using the State-Based Stress Visual Analogue Scale
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
Measured: baseline, 8 weeks, 6 months, 12 months
change in mindfulness using the 5-Facet Mindfulness Sub-scales
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
Measured: baseline, 8 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study startJul 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Following participation in the 8-week course, participants will be randomized to either 4 months of: 1) weekly MBSR specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Endeavor Health
- Responsible party
- Principal investigator, David Victorson, Northwestern University
- Investigators
- David E Victorson, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852030
- Sponsor's protocol ID
- EH09-202
- Status last verified
- Jun 2023
- First submitted
- 12 Dec 2018
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Latini DM, Hart SL, Knight SJ, Cowan JE, Ross PL, Duchane J, Carroll PR; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol. 2007 Sep;178(3 Pt 1):826-31; discussion 831-2. doi: 10.1016/j.juro.2007.05.039. Epub 2007 Jul 16.
PubMed 17632144Mehnert A, Lehmann C, Schulte T, Koch U. Presence of symptom distress and prostate cancer-related anxiety in patients at the beginning of cancer rehabilitation. Onkologie. 2007 Nov;30(11):551-6. doi: 10.1159/000108578. Epub 2007 Oct 16.
PubMed 17992025Miller DC, Sanda MG, Dunn RL, Montie JE, Pimentel H, Sandler HM, McLaughlin WP, Wei JT. Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy. J Clin Oncol. 2005 Apr 20;23(12):2772-80. doi: 10.1200/JCO.2005.07.116.
PubMed 15837992Liu J, Mittendorf T, von der Schulenburg JM. A structured review and guide through studies on health-related quality of life in kidney cancer, hepatocellular carcinoma, and leukemia. Cancer Invest. 2010 Mar;28(3):312-22. doi: 10.3109/07357900903287022.
PubMed 19863345Somani BK, Gimlin D, Fayers P, N'dow J. Quality of life and body image for bladder cancer patients undergoing radical cystectomy and urinary diversion--a prospective cohort study with a systematic review of literature. Urology. 2009 Nov;74(5):1138-43. doi: 10.1016/j.urology.2009.05.087. Epub 2009 Sep 20.
PubMed 19773042Carpentier MY, Fortenberry JD. Romantic and sexual relationships, body image, and fertility in adolescent and young adult testicular cancer survivors: a review of the literature. J Adolesc Health. 2010 Aug;47(2):115-25. doi: 10.1016/j.jadohealth.2010.04.005. Epub 2010 Jun 11.
PubMed 20638003Kuczyk M, Machtens S, Bokemeyer C, Schultheiss D, Jonas U. Sexual function and fertility after treatment of testicular cancer. Curr Opin Urol. 2000 Sep;10(5):473-7. doi: 10.1097/00042307-200009000-00018.
PubMed 11005454Huddart RA, Norman A, Moynihan C, Horwich A, Parker C, Nicholls E, Dearnaley DP. Fertility, gonadal and sexual function in survivors of testicular cancer. Br J Cancer. 2005 Jul 25;93(2):200-7. doi: 10.1038/sj.bjc.6602677.
PubMed 15999104Matos E, Skrbinc B, Zakotnik B. Fertility in patients treated for testicular cancer. J Cancer Surviv. 2010 Sep;4(3):274-8. doi: 10.1007/s11764-010-0135-9. Epub 2010 Jul 3.
PubMed 20602187Cella D. Quality of life in patients with metastatic renal cell carcinoma: the importance of patient-reported outcomes. Cancer Treat Rev. 2009 Dec;35(8):733-7. doi: 10.1016/j.ctrv.2009.07.003. Epub 2009 Aug 21.
PubMed 19699588Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.
PubMed 11305069Astin JA. Stress reduction through mindfulness meditation. Effects on psychological symptomatology, sense of control, and spiritual experiences. Psychother Psychosom. 1997;66(2):97-106. doi: 10.1159/000289116.
PubMed 9097338Kabat-Zinn J. Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing; 1990
Bishop SR, Lau M, Shapiro S et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice 2004;11(3):230-241
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03852030
- Acronym / sponsor ID
- EH09-202
- Conditions
- Prostate Cancer, Kidney Cancer, Bladder Cancer
- Keywords
- prostate cancer, mindfulness, eHealth, kidney cancer, bladder cancer, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Endeavor Health
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.
Detailed description
Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Following participation in the 8-week course, participants will be randomized to either 4 months of: 1) weekly MBSR specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness text/email message | Experimental | Behavioral: Text or email messageWeekly MBSR specific text or email messages related to course teachings were sent. TYPES OF MESSAGES INCLUDED: Non-reaction; Non-Judgment; Awareness; Loving Kindness; Acceptance. |
| Health promotion text/email message | Placebo comparator | Behavioral: Text or email messageWeekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress. |
| No text/email message | No intervention | –No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer
- Spouses/significant others will only be included if their partners with cancer diagnoses will be participating
- 18 years old or older
- Proficient in comprehending spoken English. Proficient in reading and writing English.
Key exclusion criteria (6 listed)
- Is not able to receive email or text messages
- History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated.
- Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised.
- Diminished cognitive skills as to render consent meaningless
- Physical debilitation such that study participation would not be feasible or would create undue hardship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text or email messageText or email messages sent to research participants | Behavioural | Health promotion text/email message, Mindfulness text/email message |
Primary outcome
change in fatigue using the PROMIS Fatigue questionnaire
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
change in depression using the PROMIS Depression questionnaire
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
change in anxiety using the PROMIS Anxiety questionnaire
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
change in sleep using the PROMIS Sleep Disturbance questionnaire
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
change in physical function using the PROMIS Physical Function questionnaire
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
change in stress using the State-Based Stress Visual Analogue Scale
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
change in mindfulness using the 5-Facet Mindfulness Sub-scales
Time frame: baseline, 8 weeks, 6 months, 12 months
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 17632144Latini DM, Hart SL, Knight SJ, Cowan JE, Ross PL, Duchane J, Carroll PR; CaPSURE Investigators. The relationship between anxiety and time to treatment for patients with prostate cancer on surveillance. J Urol. 2007 Sep;178(3 Pt 1):826-31; discussion 831-2. doi: 10.1016/j.juro.2007.05.039. Epub 2007 Jul 16.
- Background: PubMed 17992025Mehnert A, Lehmann C, Schulte T, Koch U. Presence of symptom distress and prostate cancer-related anxiety in patients at the beginning of cancer rehabilitation. Onkologie. 2007 Nov;30(11):551-6. doi: 10.1159/000108578. Epub 2007 Oct 16.
- Background: PubMed 15837992Miller DC, Sanda MG, Dunn RL, Montie JE, Pimentel H, Sandler HM, McLaughlin WP, Wei JT. Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy. J Clin Oncol. 2005 Apr 20;23(12):2772-80. doi: 10.1200/JCO.2005.07.116.
- Background: PubMed 19863345Liu J, Mittendorf T, von der Schulenburg JM. A structured review and guide through studies on health-related quality of life in kidney cancer, hepatocellular carcinoma, and leukemia. Cancer Invest. 2010 Mar;28(3):312-22. doi: 10.3109/07357900903287022.
- Background: PubMed 19773042Somani BK, Gimlin D, Fayers P, N'dow J. Quality of life and body image for bladder cancer patients undergoing radical cystectomy and urinary diversion--a prospective cohort study with a systematic review of literature. Urology. 2009 Nov;74(5):1138-43. doi: 10.1016/j.urology.2009.05.087. Epub 2009 Sep 20.
- Background: PubMed 20638003Carpentier MY, Fortenberry JD. Romantic and sexual relationships, body image, and fertility in adolescent and young adult testicular cancer survivors: a review of the literature. J Adolesc Health. 2010 Aug;47(2):115-25. doi: 10.1016/j.jadohealth.2010.04.005. Epub 2010 Jun 11.
- Background: PubMed 11005454Kuczyk M, Machtens S, Bokemeyer C, Schultheiss D, Jonas U. Sexual function and fertility after treatment of testicular cancer. Curr Opin Urol. 2000 Sep;10(5):473-7. doi: 10.1097/00042307-200009000-00018.
- Background: PubMed 15999104Huddart RA, Norman A, Moynihan C, Horwich A, Parker C, Nicholls E, Dearnaley DP. Fertility, gonadal and sexual function in survivors of testicular cancer. Br J Cancer. 2005 Jul 25;93(2):200-7. doi: 10.1038/sj.bjc.6602677.
- Background: PubMed 20602187Matos E, Skrbinc B, Zakotnik B. Fertility in patients treated for testicular cancer. J Cancer Surviv. 2010 Sep;4(3):274-8. doi: 10.1007/s11764-010-0135-9. Epub 2010 Jul 3.
- Background: PubMed 19699588Cella D. Quality of life in patients with metastatic renal cell carcinoma: the importance of patient-reported outcomes. Cancer Treat Rev. 2009 Dec;35(8):733-7. doi: 10.1016/j.ctrv.2009.07.003. Epub 2009 Aug 21.
- Background: PubMed 11305069Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.
- Background: PubMed 9097338Astin JA. Stress reduction through mindfulness meditation. Effects on psychological symptomatology, sense of control, and spiritual experiences. Psychother Psychosom. 1997;66(2):97-106. doi: 10.1159/000289116.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Victorson, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text or email message in people with Prostate Cancer and Kidney Cancer, run by Northwestern University at 2 sites 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 4 inclusion and 6 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 fatigue using the PROMIS Fatigue questionnaire (time frame: baseline, 8 weeks, 6 months, 12 months). The study lists 7 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 NCT03852030, which also lists 53 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 13 Jun 2023.