AnxietyNCT03174808
Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Anxiety and Quality of Life, run by Yale University at 1 site in United States.
Trial summary
The primary objective is to assess the feasibly, adherence, and effects of mindfulness-based stress reduction (MBSR) on anxiety and health-related quality of life in adult patients with cutaneous T-cell lymphoma at the Yale Cancer Center/Smilow Cancer Hospital. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anxiety, Quality of Life
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2017to 26 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identified with lymphoma through the Yale Cancer Center Hematology Clinic.
- Access to mobile telephone/smartphone with text messaging plan in order to receive survey questions.
- Current CTCL patients in Dr. Foss's practice at the Yale Cancer Center.
Who cannot join
- Current regular mindfulness meditation activity (weekly or more frequent practice of self-defined meditation, formalized relaxation techniques, tai chi, and meditative yoga).
- Inability or unwillingness to give consent.
- Serious illness (including mental illness/psychopathology) within 90 days prior to screening, including hospitalization for chronic disease. Determination of 'serious' will be made by PI and research team. For example, unstable asthma, cancers (except non-melanoma skin cancer and CTCL), and schizophrenia will be considered 'serious,' while stable asthma, allergic rhinitis, esophageal reflux, generalized anxiety disorder, or attention deficit disorder will not be considered 'serious.
- Active participation (weekly or more often) in a cancer or chronic disease support group.
- Active substance abusers.
- Current suicidal ideation, operationally defined as affirmative responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Cancer Center/Smilow
New Haven, Connecticut, 06511
About this study
The primary objective is to assess the feasibly, adherence, and effects of mindfulness-based stress reduction (MBSR) on anxiety and health-related quality of life in adult patients with cutaneous T-cell lymphoma at the Yale Cancer Center/Smilow Cancer Hospital.
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. The mindfulness meditation group sessions will take place at the Smilow Cancer Center at the Yale New-Haven Hospital.
Read the detailed description
Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard mindfulness-based stress reduction (MBSR) protocol. Participants will be assigned home practice based on the MBSR protocol, and will be given audio recordings (MP3) to accompany and instruct in home practice.
Eligible participants will attend weekly group sessions for 8 weeks and will be assessed at baseline, following cessation of the intervention (8-weeks), and 16 weeks. Outcomes will be assessed at baseline, 8 weeks, and 16 weeks. Extended effects of the intervention will be assessed at 16 weeks.
- Conditions
- Anxiety, Quality of Life
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- cutaneous T-cell lymphoma
- Medical subject headings
- Anxiety Disorders, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility of the intervention will be assessed by the proportion of eligible patients attend the majority of the MBSR sessions (5 or more), and complete week-8 and week-16 assessments.
Measured: 16 weeks
Adherence
Adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly practice logs and/or SMS (short message service)/text messaging. Adherence will be quantitatively assessed through tallying home practice time and number of intervention visits attended.
Measured: 16 weeks
Secondary outcomes (2)
Stress
The Perceived Stress Scale (PSS) has been used in past Mindfulness treatment studies. The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often) (e.g., 'How often have you been upset because of something that happened unexpectedly?). Higher total scores indicate greater levels of perceived stress.
Measured: baseline, 8 weeks, and 16 weeks
Quality of Life
The Functional Assessment of Cancer Therapy-General (FACT-G) is a cancer-focused measure of quality of life and well-being. It is a standard assessment at the Yale Survivorship clinic. It includes 27 items and encompasses 4 different indices of well-being: physical, social/family, emotional, and functional well-being and has been used to evaluate cancer-related QOL in many studies.
Measured: baseline, 8 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Aug 2017
- Primary completion31 Oct 2017
- Study completion26 Nov 2018
Why it stopped: PI unexpectedly passed away, study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Yale 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- The Wallace Foundation
- Responsible party
- Sponsor
- Investigators
- Eugene Shapiro, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174808
- Sponsor's protocol ID
- 2000020161
- Status last verified
- Nov 2019
- First submitted
- 31 May 2017
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)
- ClinicalTrials.gov ID
- NCT03174808
- Acronym / sponsor ID
- 2000020161
- Conditions
- Anxiety, Quality of Life
- Keywords
- cutaneous T-cell lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI unexpectedly passed away, study closed.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- The Wallace Foundation
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 5 Jun 2017 (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.
The primary objective is to assess the feasibly, adherence, and effects of mindfulness-based stress reduction (MBSR) on anxiety and health-related quality of life in adult patients with cutaneous T-cell lymphoma at the Yale Cancer Center/Smilow Cancer Hospital.
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. The mindfulness meditation group sessions will take place at the Smilow Cancer Center at the Yale New-Haven Hospital.
Detailed description
Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard mindfulness-based stress reduction (MBSR) protocol. Participants will be assigned home practice based on the MBSR protocol, and will be given audio recordings (MP3) to accompany and instruct in home practice.
Eligible participants will attend weekly group sessions for 8 weeks and will be assessed at baseline, following cessation of the intervention (8-weeks), and 16 weeks. Outcomes will be assessed at baseline, 8 weeks, and 16 weeks. Extended effects of the intervention will be assessed at 16 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Identified with lymphoma through the Yale Cancer Center Hematology Clinic.
- Access to mobile telephone/smartphone with text messaging plan in order to receive survey questions.
- Current CTCL patients in Dr. Foss's practice at the Yale Cancer Center.
Key exclusion criteria (6 listed)
- Current regular mindfulness meditation activity (weekly or more frequent practice of self-defined meditation, formalized relaxation techniques, tai chi, and meditative yoga).
- Inability or unwillingness to give consent.
- Serious illness (including mental illness/psychopathology) within 90 days prior to screening, including hospitalization for chronic disease. Determination of 'serious' will be made by PI and research team. For example, unstable asthma, cancers (except non-melanoma skin cancer and CTCL), and schizophrenia will be considered 'serious,' while stable asthma, allergic rhinitis, esophageal reflux, generalized anxiety disorder, or attention deficit disorder will not be considered 'serious.
- Active participation (weekly or more often) in a cancer or chronic disease support group.
- Active substance abusers.
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 |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR)Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol. | Behavioural | Mindfulness-Based Stress Reduction (MBSR) |
Primary outcome
Feasibility
Time frame: 16 weeks
Feasibility of the intervention will be assessed by the proportion of eligible patients attend the majority of the MBSR sessions (5 or more), and complete week-8 and week-16 assessments.
Adherence
Time frame: 16 weeks
Adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly practice logs and/or SMS (short message service)/text messaging. Adherence will be quantitatively assessed through tallying home practice time and number of intervention visits attended.
2 secondary outcomes
Stress
Time frame: baseline, 8 weeks, and 16 weeks
Quality of Life
Time frame: baseline, 8 weeks, and 16 weeks
Results and safety
The study was stopped early (reason given: PI unexpectedly passed away, study closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Eugene Shapiro, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Anxiety and Quality of Life, run by Yale 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 3 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: stopped early, as of the sponsor's last update on 27 Nov 2019. 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 was stopped early (reason given: PI unexpectedly passed away, study closed.). Results are not available in the source record.
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 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2019.