NCT03174808

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

May 31, 2017

Last Update Submit

November 25, 2019

Conditions

AnxietyQuality of Life

Keywords

cutaneous T-cell lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    16 weeks

Secondary Outcomes (2)

  • Stress

    baseline, 8 weeks, and 16 weeks

  • Quality of Life

    baseline, 8 weeks, and 16 weeks

Other Outcomes (7)

  • Depression

    baseline, 8 weeks, and 16 weeks

  • Anxiety

    baseline, 8 weeks, and 16 weeks

  • Healing

    baseline, 8 weeks, and 16 weeks

  • +4 more other outcomes

Study Arms (1)

Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL

Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting.

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Interventions

Mindfulness-Based Stress Reduction (MBSR)BEHAVIORAL

Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.

Mindfulness-Based Stress Reduction (MBSR)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Cancer Center/Smilow

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Anxiety DisordersLymphoma, T-Cell, Cutaneous

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental DisordersLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eugene Shapiro, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

August 20, 2017

Primary Completion

October 31, 2017

Study Completion

November 26, 2018

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)