Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Mindfulness Interventions and Cutaneous T Cell Lymphoma (CTCL)

25 novembre 2019 aggiornato da: Yale University

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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

3

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06511
        • Yale Cancer Center/Smilow

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Mindfulness-Based Stress Reduction (MBSR)
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting.
Comportamentale: Mindfulness-Based Stress Reduction (MBSR)
Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility
Lasso di tempo: 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.
16 weeks
Adherence
Lasso di tempo: 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.
16 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stress
Lasso di tempo: baseline, 8 weeks, and 16 weeks
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.
baseline, 8 weeks, and 16 weeks
Quality of Life
Lasso di tempo: baseline, 8 weeks, and 16 weeks
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.
baseline, 8 weeks, and 16 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Depression
Lasso di tempo: baseline, 8 weeks, and 16 weeks
The Hospital Anxiety and Depression Scale (HADS) has been used to measure levels of anxiety and depression that a patient is experiencing. The HADS has fourteen items, seven of which relate to anxiety and other seven of which related to depression. Each item is scored on a 0-3 scale. Higher total scores indicate greater levels of perceived anxiety/depression.
baseline, 8 weeks, and 16 weeks
Anxiety
Lasso di tempo: baseline, 8 weeks, and 16 weeks
The Hospital Anxiety and Depression Scale (HADS) has been used to measure levels of anxiety and depression that a patient is experiencing. The HADS has fourteen items, seven of which relate to anxiety and other seven of which related to depression. Each item is scored on a 0-3 scale. Higher total scores indicate greater levels of perceived anxiety/depression.
baseline, 8 weeks, and 16 weeks
Healing
Lasso di tempo: baseline, 8 weeks, and 16 weeks
The Healing Encounters and Attitudes Lists (HEAL) questionnaires have been used to measure the nonspecific factors in healing process including patient-provider connection, treatment expectancy, healthcare environment, positive outlook, spirituality and attitude towards complementary and alternative medicine. The HEAL item banks comprise six subscales, each of which has 6-7 questions. Each item is scored on a 1-5 scale. The HEAL measures have been well validated in integrative medicine research.
baseline, 8 weeks, and 16 weeks
Effect of Skin Disease
Lasso di tempo: baseline, 8 weeks, and 16 weeks
The Skindex-29 profiles are a 29-item measure that assesses the symptomatic, emotional, and functional effects of skin diseases on quality of life. It is widely used in patients with nonmelanoma skin cancer including CTCL. Items are scored based on how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item. All responses are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time).
baseline, 8 weeks, and 16 weeks
Client Credibility
Lasso di tempo: week 1
The Client Credibility Questionnaire (CCQ) will be used to assess subject expectations and beliefs about the mindfulness program at baseline using a questionnaire modeled after the methods of Sherman et al. The CCQ will be administered to all subjects at the end of the first MBSR class, after the outline and rationale of the intervention has been presented. Subjects will be asked to make ratings using an 8-point Likert scale (0= not at all to 8=very much) about: (1) how logical the program seems; (2) how confident they are the program will be successful in reducing symptoms; and (3) how confident they would be in recommending the program to a friend.
week 1
Suicide Severity
Lasso di tempo: screening/baseline
Columbia-Suicide Severity Rating Scale (C-SSRS) is a 2-item, self-report questionnaire that includes items suicidal ideations in the past week and the past year. Questions include: (1) Have you wished you were dead or wished you could go to sleep and not wake up? and (2) Have you actually had any thoughts of killing yourself? Any positive (yes) responses during the past week are immediately referred to Yale-New Haven Children's Hospital.
screening/baseline
Disease Progress
Lasso di tempo: baseline, 8 weeks, and 16 weeks

The Eastern Cooperative Oncology Group (ECOG) assessment will be used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. ECOG is graded from 0 to 5.

0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5 = Dead .
baseline, 8 weeks, and 16 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Yale University

Collaboratori

Wallace Research Foundation

Investigatori

  • Investigatore principale: Eugene Shapiro, MD, Yale University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 agosto 2017

Completamento primario (Effettivo)

31 ottobre 2017

Completamento dello studio (Effettivo)

26 novembre 2018

Date di iscrizione allo studio

Primo inviato

31 maggio 2017

Primo inviato che soddisfa i criteri di controllo qualità

31 maggio 2017

Primo Inserito (Effettivo)

5 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 novembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 novembre 2019

Ultimo verificato

1 novembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2000020161

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Qualità della vita

Prove cliniche su Mindfulness-Based Stress Reduction (MBSR)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United Arab Emirates

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi