CancerREDEFINEAYAONCT02495376
Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
A study testing MBSR in people with Cancer, run by Northwestern University at 2 sites in United States.
Trial summary
We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Dec 2017
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have a diagnosis of any cancer between ages 18-39
- Must have signed and dated informed consent form, which includes agreeing to study procedures
- Must be currently between 18-39 years of age
- Must be able to read, write, speak and understand English
- Must be able to perform basic activities of daily living
- Must be cognitively intact and free of serious psychiatric illness
Show all 10Show fewer
- Must have the ability to use a touchscreen keypad on a tablet device
- Must be willing to commit to either the MBSR course or waitlist control condition
- Must be willing to commit to eHealth intervention maintenance conditions
- Must be willing to complete all assessments
Who cannot join
- Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
- History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians
- Regular user of mindfulness-based stress reduction or a similar mind-body therapy (e.g., yoga, meditation), which is defined as ≥ 3 times a week for the past 2 weeks
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
About this study
Official title: REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. The proposed work will serve as an essential foundation for launching a program of clinical stress reduction research with this traditionally underserved population and has the potential to lead to the discovery of specific, modifiable psychosocial, behavioral, and biological mechanisms from which to address the problem of health disparities with this group.
Read the detailed description
Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize that MBSR will be feasible and acceptable with this population, which will be assessed through examination of response rate and study attrition variables.
Secondary Objectives
- Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs.
- Explore the impact of different forms of eHealth maintenance support following the MBSR intervention (instructor-delivered, peer-delivered, no message) to help uphold intervention effects over time.
- Compare intervention and control groups on changes in biologic measures of stress (blood pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.
- Conditions
- Cancer
- Being tested
- MBSR
- Keywords
- YACS, cancer, MBSR
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Also called mindfulness based stress reduction
Based primarily on the instruction of mindfulness meditation and yoga, MBSR 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A participates in the first available MBSR course. Receives: Behavioral: MBSR |
| Group B | Active comparator | Group B waits 16 weeks before participating in the MBSR course. Receives: Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility assessed through examination of response rate and study attrition variables
feasibility assessed through examination of response rate and study attrition variables
Measured: week 33
Secondary outcomes (3)
effects on health related quality of life accessed through online questionnaires
effects on health related quality of life accessed through online questionnaires
Measured: baseline and study weeks 8, 16, 24, and 32
the impact of eHealth maintenance support accessed through text message response
the impact of eHealth maintenance support accessed through text message response
Measured: weekly, for the 8 consecutive weeks after the MBSR course
compare between-group changes in biologic measures of stress accessed through biomarkers
compare between-group changes in biologic measures of stress accessed through
Measured: baseline and study weeks 16 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (90)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Robert H. Lurie Cancer Center
- Responsible party
- Principal investigator, David Victorson, Northwestern University
- Investigators
- David E Victorson, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495376
- Sponsor's protocol ID
- STU00093614
- Acronym
- REDEFINEAYAO
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2015
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bleyer A. The adolescent and young adult gap in cancer care and outcome. Curr Probl Pediatr Adolesc Health Care. 2005 May-Jun;35(5):182-217. doi: 10.1016/j.cppeds.2005.02.001. No abstract available.
PubMed 15841070Bleyer A. Young adult oncology: the patients and their survival challenges. CA Cancer J Clin. 2007 Jul-Aug;57(4):242-55. doi: 10.3322/canjclin.57.4.242.
PubMed 17626120White PH. Access to health care: health insurance considerations for young adults with special health care needs/disabilities. Pediatrics. 2002 Dec;110(6 Pt 2):1328-35.
PubMed 12456953Kirchhoff AC, Lyles CR, Fluchel M, Wright J, Leisenring W. Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. Cancer. 2012 Dec 1;118(23):5964-72. doi: 10.1002/cncr.27537. Epub 2012 Sep 24.
PubMed 23007632Crom DB, Lensing SY, Rai SN, Snider MA, Cash DK, Hudson MM. Marriage, employment, and health insurance in adult survivors of childhood cancer. J Cancer Surviv. 2007 Sep;1(3):237-45. doi: 10.1007/s11764-007-0026-x.
PubMed 18648974Callahan ST, Cooper WO. Uninsurance and health care access among young adults in the United States. Pediatrics. 2005 Jul;116(1):88-95. doi: 10.1542/peds.2004-1449.
PubMed 15995037Martin S, Ulrich C, Munsell M, Taylor S, Lange G, Bleyer A. Delays in cancer diagnosis in underinsured young adults and older adolescents. Oncologist. 2007 Jul;12(7):816-24. doi: 10.1634/theoncologist.12-7-816.
PubMed 17673613Burke ME, Albritton K, Marina N. Challenges in the recruitment of adolescents and young adults to cancer clinical trials. Cancer. 2007 Dec 1;110(11):2385-93. doi: 10.1002/cncr.23060.
PubMed 17918260Ferrari A, Montello M, Budd T, Bleyer A. The challenges of clinical trials for adolescents and young adults with cancer. Pediatr Blood Cancer. 2008 May;50(5 Suppl):1101-4. doi: 10.1002/pbc.21459.
PubMed 18360838Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42. doi: 10.1016/s0031-3955(02)00035-4.
PubMed 12430624Mattson MR, Demshar RK, Daly BJ. Quality of life of young adult survivors of hematologic malignancies. Cancer Nurs. 2013 Mar-Apr;36(2):E1-7. doi: 10.1097/NCC.0b013e31824242dd.
PubMed 22293158Victorson D, Cella D, Wagner LI, Kramer L, Smith ML. Measuring quality of life in cancer survivors. In: Feuerstein M, ed. Handbook of cancer survivorship. New York, NY: Springer; 2007:79-112.
Kwak M, Zebrack BJ, Meeske KA, Embry L, Aguilar C, Block R, Hayes-Lattin B, Li Y, Butler M, Cole S. Prevalence and predictors of post-traumatic stress symptoms in adolescent and young adult cancer survivors: a 1-year follow-up study. Psychooncology. 2013 Aug;22(8):1798-806. doi: 10.1002/pon.3217. Epub 2012 Nov 8.
PubMed 23135830Phillips-Salimi CR, Andrykowski MA. Physical and mental health status of female adolescent/young adult survivors of breast and gynecological cancer: a national, population-based, case-control study. Support Care Cancer. 2013 Jun;21(6):1597-604. doi: 10.1007/s00520-012-1701-7. Epub 2013 Jan 10.
PubMed 23306935Mor V, Malin M, Allen S. Age differences in the psychosocial problems encountered by breast cancer patients. J Natl Cancer Inst Monogr. 1994;(16):191-7. No abstract available.
PubMed 7999464
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDEFINE AYAO: Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology
- ClinicalTrials.gov ID
- NCT02495376
- Acronym / sponsor ID
- REDEFINEAYAO / STU00093614
- Conditions
- Cancer
- Keywords
- YACS, cancer, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Robert H. Lurie Cancer Center
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jul 2015 (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 effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. The proposed work will serve as an essential foundation for launching a program of clinical stress reduction research with this traditionally underserved population and has the potential to lead to the discovery of specific, modifiable psychosocial, behavioral, and biological mechanisms from which to address the problem of health disparities with this group.
Detailed description
Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize that MBSR will be feasible and acceptable with this population, which will be assessed through examination of response rate and study attrition variables.
Secondary Objectives
- Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs.
- Explore the impact of different forms of eHealth maintenance support following the MBSR intervention (instructor-delivered, peer-delivered, no message) to help uphold intervention effects over time.
- Compare intervention and control groups on changes in biologic measures of stress (blood pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: MBSRGroup A participates in the first available MBSR course. |
| Group B | Active comparator | Behavioral: MBSRGroup B waits 16 weeks before participating in the MBSR course. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Must have a diagnosis of any cancer between ages 18-39
- Must have signed and dated informed consent form, which includes agreeing to study procedures
- Must be currently between 18-39 years of age
- Must be able to read, write, speak and understand English
- Must be able to perform basic activities of daily living
Key exclusion criteria (3 listed)
- Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
- History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians
- Regular user of mindfulness-based stress reduction or a similar mind-body therapy (e.g., yoga, meditation), which is defined as ≥ 3 times a week for the past 2 weeks
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 |
|---|---|---|
| MBSRAlso: mindfulness based stress reductionBased primarily on the instruction of mindfulness meditation and yoga, MBSR 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. | Behavioural | Group A, Group B |
Primary outcome
feasibility assessed through examination of response rate and study attrition variables
Time frame: week 33
feasibility assessed through examination of response rate and study attrition variables
3 secondary outcomes
effects on health related quality of life accessed through online questionnaires
Time frame: baseline and study weeks 8, 16, 24, and 32
the impact of eHealth maintenance support accessed through text message response
Time frame: weekly, for the 8 consecutive weeks after the MBSR course
compare between-group changes in biologic measures of stress accessed through biomarkers
Time frame: baseline and study weeks 16 and 32
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 5 Aug 2021.
- Background: PubMed 15841070Bleyer A. The adolescent and young adult gap in cancer care and outcome. Curr Probl Pediatr Adolesc Health Care. 2005 May-Jun;35(5):182-217. doi: 10.1016/j.cppeds.2005.02.001. No abstract available.
- Background: PubMed 17626120Bleyer A. Young adult oncology: the patients and their survival challenges. CA Cancer J Clin. 2007 Jul-Aug;57(4):242-55. doi: 10.3322/canjclin.57.4.242.
- Background: PubMed 12456953White PH. Access to health care: health insurance considerations for young adults with special health care needs/disabilities. Pediatrics. 2002 Dec;110(6 Pt 2):1328-35.
- Background: PubMed 23007632Kirchhoff AC, Lyles CR, Fluchel M, Wright J, Leisenring W. Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. Cancer. 2012 Dec 1;118(23):5964-72. doi: 10.1002/cncr.27537. Epub 2012 Sep 24.
- Background: PubMed 18648974Crom DB, Lensing SY, Rai SN, Snider MA, Cash DK, Hudson MM. Marriage, employment, and health insurance in adult survivors of childhood cancer. J Cancer Surviv. 2007 Sep;1(3):237-45. doi: 10.1007/s11764-007-0026-x.
- Background: PubMed 15995037Callahan ST, Cooper WO. Uninsurance and health care access among young adults in the United States. Pediatrics. 2005 Jul;116(1):88-95. doi: 10.1542/peds.2004-1449.
- Background: PubMed 17673613Martin S, Ulrich C, Munsell M, Taylor S, Lange G, Bleyer A. Delays in cancer diagnosis in underinsured young adults and older adolescents. Oncologist. 2007 Jul;12(7):816-24. doi: 10.1634/theoncologist.12-7-816.
- Background: PubMed 17918260Burke ME, Albritton K, Marina N. Challenges in the recruitment of adolescents and young adults to cancer clinical trials. Cancer. 2007 Dec 1;110(11):2385-93. doi: 10.1002/cncr.23060.
- Background: PubMed 18360838Ferrari A, Montello M, Budd T, Bleyer A. The challenges of clinical trials for adolescents and young adults with cancer. Pediatr Blood Cancer. 2008 May;50(5 Suppl):1101-4. doi: 10.1002/pbc.21459.
- Background: PubMed 12430624Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42. doi: 10.1016/s0031-3955(02)00035-4.
- Background: PubMed 22293158Mattson MR, Demshar RK, Daly BJ. Quality of life of young adult survivors of hematologic malignancies. Cancer Nurs. 2013 Mar-Apr;36(2):E1-7. doi: 10.1097/NCC.0b013e31824242dd.
- BackgroundVictorson D, Cella D, Wagner LI, Kramer L, Smith ML. Measuring quality of life in cancer survivors. In: Feuerstein M, ed. Handbook of cancer survivorship. New York, NY: Springer; 2007:79-112.
- American Cancer Society I. Cancer in Teens and Young Adults: Not Much Improvement? Accessed on February 24, 2013.Link provided by the sponsor.
- 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 MBSR in people with 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 10 inclusion and 3 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 5 Aug 2021. 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. 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?
feasibility assessed through examination of response rate and study attrition variables (time frame: week 33). 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 NCT02495376, which also lists 90 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 5 Aug 2021.