Prostate CancerREASSUREMENCT02871752
Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education
A study testing Health promotion in people with Prostate Cancer, run by Northwestern University at 4 sites in United States.
Trial summary
We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their 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
- What is being tested?
- Health promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Aug 2016to 30 Jan 2023
- 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
- Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance)
- Must be at least 18 years of age
- Must be able to read, write, speak and understand English
- Must be able to perform basic activities of daily living (as determined by referring physician)
- Must be cognitively intact and free of serious psychiatric illness (as determined by referring physician)
- Must have access to the internet and ability to locate the assessment URL and/or ability to use a touchscreen keypad on a tablet device
- Must be willing to commit to the 8-week MBSR or Health Promotion course, which includes attending weekly, 2.5 hours classes over an 8 week period, a half-day retreat between week 6 and 7 , and daily homework assignments
- Must be willing to complete study assessments
Who cannot join
- Unable to provide consent
- Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Northwestern University
Chicago, Illinois, 60611
NorthShore University HealthSystem
Evanston, Illinois, 60201
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their spouses.
Read the detailed description
The current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a larger, more geographically representative sample of men on AS and their spouses. We will compare the MBSR intervention condition (Group A) with a health promotion and wellness condition (Group B) in a sample of prostate cancer patients and their spouses. We will evaluate its efficacy on self-reported measures of positive and negative psychological responses to AS.
PRIMARY AIM Examine longitudinal change in positive and negative psychological responses to AS between groups over time.
SECONDARY AIM Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.
THIRD AIM Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.
- Conditions
- Prostate Cancer
- Being tested
- Health promotion
- Keywords
- prostate cancer, active surveillance, MBSR, couples, health promotion, quality of life, mindfulness
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotionBehavioural
mindfulness-based stress reduction
| Study group | Role | What they receive |
|---|---|---|
| MBSR (Mindfulness condition) | Experimental | MBSR (mindfulness-based stress reduction) is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations. Lesson activities include the following: (1) mindful meditation (e.g., awareness of breathing, body scan, sitting, walking); (2) yoga; and (3) group discussion. Receives: Behavioral: Health promotion |
| HealthPro (Control Matched Condition) | Active comparator | HealthPro is a health promotion program designed by Dr. David Victorson of Northwestern University Medical Social Sciences Department and his research team to function as a matched control for the MBSR intervention in this research study. The program teaches and promotes healthy behaviors, skills, and lifestyles. Major learning themes include: (1) health behavioral change readiness and self-assessment; (2) physical activity, movement, and non-sedentary lifestyles; (3) dietary and nutritional considerations for optimal health; (4) emotional wellness and coping with difficulties; (5) social engagement, relationships intimacy, and health; (6) managing bodily pain; (7) weight management and weight loss strategies; (8) health behavior maintenance over the long-term. Receives: Behavioral: Health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
longitudinal change in psychological responses as assessed through online survey
longitudinal change in psychological responses as assessed through online survey
Measured: Baseline, Week 8, Month 6, Month 12
Secondary outcomes (2)
relation between psychological responses to AS as assessed by online survey
relation between psychological responses to AS as assessed by online survey
Measured: Baseline, Week 8, Month 6, Month 12
dyadic factors on psychological responses as assessed by online survey
dyadic factors on psychological responses as assessed by online survey
Measured: Baseline, Week 8, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Fox Chase Cancer Center, University of Michigan, Endeavor Health, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Victorson, Northwestern University
- Investigators
- David E Victorson, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871752
- Sponsor's protocol ID
- STU00105259
- Other IDs
- R01CA193331-01A1
- Acronym
- REASSUREME
- Status last verified
- Mar 2023
- First submitted
- 5 Aug 2016
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eton DT, Lepore SJ, Helgeson VS. Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors. Cancer. 2001 Sep 15;92(6):1451-9. doi: 10.1002/1097-0142(20010915)92:63.0.co;2-r.
PubMed 11745222Eton DT, Lepore SJ, Helgeson VS. Psychological distress in spouses of men treated for early-stage prostate carcinoma. Cancer. 2005 Jun 1;103(11):2412-8. doi: 10.1002/cncr.21092.
PubMed 15858824Eton DT, Lepore SJ. Prostate cancer and health-related quality of life: a review of the literature. Psychooncology. 2002 Jul-Aug;11(4):307-26. doi: 10.1002/pon.572.
PubMed 12203744Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
PubMed 33532112Salminen EK, Portin RI, Koskinen AI, Helenius HY, Nurmi MJ. Estradiol and cognition during androgen deprivation in men with prostate carcinoma. Cancer. 2005 Apr 1;103(7):1381-7. doi: 10.1002/cncr.20962.
PubMed 15717315Krupski TL, Smith MR, Lee WC, Pashos CL, Brandman J, Wang Q, Botteman M, Litwin MS. Natural history of bone complications in men with prostate carcinoma initiating androgen deprivation therapy. Cancer. 2004 Aug 1;101(3):541-9. doi: 10.1002/cncr.20388.
PubMed 15274067Smith MR, McGovern FJ, Fallon MA, Schoenfeld D, Kantoff PW, Finkelstein JS. Low bone mineral density in hormone-naive men with prostate carcinoma. Cancer. 2001 Jun 15;91(12):2238-45.
PubMed 11413511Smith MR. Osteoporosis during androgen deprivation therapy for prostate cancer. Urology. 2002 Sep;60(3 Suppl 1):79-85; discussion 86.
PubMed 12231056Pirl WF, Siegel GI, Goode MJ, Smith MR. Depression in men receiving androgen deprivation therapy for prostate cancer: a pilot study. Psychooncology. 2002 Nov-Dec;11(6):518-23. doi: 10.1002/pon.592.
PubMed 12476433Dale W, Bilir P, Han M, Meltzer D. The role of anxiety in prostate carcinoma: a structured review of the literature. Cancer. 2005 Aug 1;104(3):467-78. doi: 10.1002/cncr.21198.
PubMed 15959911Cooperberg MR, Broering JM, Litwin MS, Lubeck DP, Mehta SS, Henning JM, Carroll PR; CaPSURE Investigators. The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry. J Urol. 2004 Apr;171(4):1393-401. doi: 10.1097/01.ju.0000107247.81471.06.
PubMed 15017184Roemeling S, Roobol MJ, Postma R, Gosselaar C, van der Kwast TH, Bangma CH, Schroder FH. Management and survival of screen-detected prostate cancer patients who might have been suitable for active surveillance. Eur Urol. 2006 Sep;50(3):475-82. doi: 10.1016/j.eururo.2006.04.019. Epub 2006 May 3.
PubMed 16713065Ganz PA, Barry JM, Burke W, Col NF, Corso PS, Dodson E, Hammond ME, Kogan BA, Lynch CF, Newcomer L, Seifter EJ, Tooze JA, Viswanath KV, Wessells H. NIH State-of-the-Science Conference Statement: Role of active surveillance in the management of men with localized prostate cancer. NIH Consens State Sci Statements. 2011 Dec 5-7;28(1):1-27.
PubMed 23392076Parker C. Active surveillance: towards a new paradigm in the management of early prostate cancer. Lancet Oncol. 2004 Feb;5(2):101-6. doi: 10.1016/S1470-2045(04)01384-1.
PubMed 14761814Parker C. Active surveillance of early prostate cancer: rationale, initial results and future developments. Prostate Cancer Prostatic Dis. 2004;7(3):184-7. doi: 10.1038/sj.pcan.4500720.
PubMed 15224088
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education
- ClinicalTrials.gov ID
- NCT02871752
- Acronym / sponsor ID
- REASSUREME / STU00105259
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, active surveillance, MBSR, couples, health promotion, quality of life, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Fox Chase Cancer Center, University of Michigan, Endeavor Health, National Cancer Institute (NCI)
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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.
We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their spouses.
Detailed description
The current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a larger, more geographically representative sample of men on AS and their spouses. We will compare the MBSR intervention condition (Group A) with a health promotion and wellness condition (Group B) in a sample of prostate cancer patients and their spouses. We will evaluate its efficacy on self-reported measures of positive and negative psychological responses to AS.
PRIMARY AIM Examine longitudinal change in positive and negative psychological responses to AS between groups over time.
SECONDARY AIM Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.
THIRD AIM Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR (Mindfulness condition) | Experimental | Behavioral: Health promotionMBSR (mindfulness-based stress reduction) is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations. Lesson activities include the following: (1) mindful meditation (e.g., awareness of breathing, body scan, sitting, walking); (2) yoga; and (3) group discussion. |
| HealthPro (Control Matched Condition) | Active comparator | Behavioral: Health promotionHealthPro is a health promotion program designed by Dr. David Victorson of Northwestern University Medical Social Sciences Department and his research team to function as a matched control for the MBSR intervention in this research study. The program teaches and promotes healthy behaviors, skills, and lifestyles. Major learning themes include: (1) health behavioral change readiness and self-assessment; (2) physical activity, movement, and non-sedentary lifestyles; (3) dietary and nutritional considerations for optimal health; (4) emotional wellness and coping with difficulties; (5) social engagement, relationships intimacy, and health; (6) managing bodily pain; (7) weight management and weight loss strategies; (8) health behavior maintenance over the long-term. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance)
- Must be at least 18 years of age
- Must be able to read, write, speak and understand English
- Must be able to perform basic activities of daily living (as determined by referring physician)
- Must be cognitively intact and free of serious psychiatric illness (as determined by referring physician)
Key exclusion criteria (2 listed)
- Unable to provide consent
- Bedridden, or 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 |
|---|---|---|
| Health promotionmindfulness-based stress reduction | Behavioural | HealthPro (Control Matched Condition), MBSR (Mindfulness condition) |
Primary outcome
longitudinal change in psychological responses as assessed through online survey
Time frame: Baseline, Week 8, Month 6, Month 12
longitudinal change in psychological responses as assessed through online survey
2 secondary outcomes
relation between psychological responses to AS as assessed by online survey
Time frame: Baseline, Week 8, Month 6, Month 12
dyadic factors on psychological responses as assessed by online survey
Time frame: Baseline, Week 8, Month 6, Month 12
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 Mar 2023.
- Background: PubMed 11745222Eton DT, Lepore SJ, Helgeson VS. Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors. Cancer. 2001 Sep 15;92(6):1451-9. doi: 10.1002/1097-0142(20010915)92:63.0.co;2-r.
- Background: PubMed 15858824Eton DT, Lepore SJ, Helgeson VS. Psychological distress in spouses of men treated for early-stage prostate carcinoma. Cancer. 2005 Jun 1;103(11):2412-8. doi: 10.1002/cncr.21092.
- Background: PubMed 12203744Eton DT, Lepore SJ. Prostate cancer and health-related quality of life: a review of the literature. Psychooncology. 2002 Jul-Aug;11(4):307-26. doi: 10.1002/pon.572.
- Background: PubMed 33532112Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
- Background: PubMed 15717315Salminen EK, Portin RI, Koskinen AI, Helenius HY, Nurmi MJ. Estradiol and cognition during androgen deprivation in men with prostate carcinoma. Cancer. 2005 Apr 1;103(7):1381-7. doi: 10.1002/cncr.20962.
- Background: PubMed 15274067Krupski TL, Smith MR, Lee WC, Pashos CL, Brandman J, Wang Q, Botteman M, Litwin MS. Natural history of bone complications in men with prostate carcinoma initiating androgen deprivation therapy. Cancer. 2004 Aug 1;101(3):541-9. doi: 10.1002/cncr.20388.
- Background: PubMed 11413511Smith MR, McGovern FJ, Fallon MA, Schoenfeld D, Kantoff PW, Finkelstein JS. Low bone mineral density in hormone-naive men with prostate carcinoma. Cancer. 2001 Jun 15;91(12):2238-45.
- Background: PubMed 12231056Smith MR. Osteoporosis during androgen deprivation therapy for prostate cancer. Urology. 2002 Sep;60(3 Suppl 1):79-85; discussion 86.
- Background: PubMed 12476433Pirl WF, Siegel GI, Goode MJ, Smith MR. Depression in men receiving androgen deprivation therapy for prostate cancer: a pilot study. Psychooncology. 2002 Nov-Dec;11(6):518-23. doi: 10.1002/pon.592.
- Background: PubMed 15959911Dale W, Bilir P, Han M, Meltzer D. The role of anxiety in prostate carcinoma: a structured review of the literature. Cancer. 2005 Aug 1;104(3):467-78. doi: 10.1002/cncr.21198.
- Background: PubMed 15017184Cooperberg MR, Broering JM, Litwin MS, Lubeck DP, Mehta SS, Henning JM, Carroll PR; CaPSURE Investigators. The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry. J Urol. 2004 Apr;171(4):1393-401. doi: 10.1097/01.ju.0000107247.81471.06.
- Background: PubMed 16713065Roemeling S, Roobol MJ, Postma R, Gosselaar C, van der Kwast TH, Bangma CH, Schroder FH. Management and survival of screen-detected prostate cancer patients who might have been suitable for active surveillance. Eur Urol. 2006 Sep;50(3):475-82. doi: 10.1016/j.eururo.2006.04.019. Epub 2006 May 3.
- 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, Ph.D. principal investigator
Northwestern University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion in people with Prostate Cancer, run by Northwestern University at 4 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 8 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 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
longitudinal change in psychological responses as assessed through online survey (time frame: Baseline, Week 8, Month 6, Month 12). 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 NCT02871752, which also lists 42 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 Mar 2023.