- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02170350
Brief Mindful Meditation Practice in Improving Quality of Life in Patients With Cancer Undergoing Radiation Therapy
Use of a Brief Mindful Meditation Practice in Adult Cancer Patients Receiving Radiation Therapy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. To investigate the feasibility of a clinical trial using a brief mindful meditation practice during radiation therapy.
SECONDARY OBJECTIVES:
I. To explore the measurable changes in quality of life, fatigue, and mindfulness while using a brief mindful meditation practice during radiation therapy.
OUTLINE:
Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.
After completion of study, patients are followed up 4-12 weeks after completion of radiation therapy.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Pathologically proven diagnosis of cancer any stage, based upon the following minimum diagnostic workup: History & physical examination, including documentation of Karnofsky Performance Status of 70 - 100% for at least 60 days prior to study entry
- Patients who are receiving a course of radiation therapy for curative or adjuvant intent
- Patient who have reported fatigue moderate or higher fatigue (based on the 0-10 Fatigue scale, a fatigue score of 5 or; see Appendix III) while on radiation treatment
- The patient must be an adult male or female 18 or older
- Patient must be capable to read and speak English and provide study specific informed consent prior to study entry
- No prior history of radiation therapy
- No history of or current active drug/alcohol dependence
- No patients being decisionally impaired
- Patients who have home access to a computer, or compact disc audio player
Exclusion Criteria:
- Patient is under the age of 18
- Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer
- Patient who have reported less than moderate fatigue (based on the 0-10 Fatigue scale, a fatigue score less than 5; see Appendix III)
- Karnofsky performance status of less than 70% within the last 60 days prior to study
- Prior history of radiation therapy
- History of or active drug/alcohol dependence or abuse
- Decisionally impaired patients
- No access to a computer, or compact disc audio player
- Patient who are unable to read and speak English
Piano di studio
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: Brief mindful meditation practice
Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.
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Studi accessori
Use brief mindful meditation practice
Altri nomi:
Ancillary studies
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Feasibility measured by the proportion of patients who are adherent, defined as successful completion of the course of home base brief mindful meditation practice (at least 8 out of 14 days) and completion of questionnaires at all time points
Lasso di tempo: Up to 12 weeks after completion of radiation therapy
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The portion of patients who complete the brief mindful meditation practice intervention and questionnaires will be computed, along with a one-sided 95% exact confidence interval.
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Up to 12 weeks after completion of radiation therapy
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes in quality of life assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Lasso di tempo: Baseline to up to 12 weeks after completion of radiation therapy
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Will be analyzed using mixed-effects linear regression.
Average changes and associated 95% confidence intervals will be estimated from these models.
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Baseline to up to 12 weeks after completion of radiation therapy
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Changes in fatigue assessed by FACIT-F
Lasso di tempo: Baseline to up to 12 weeks after completion of radiation therapy
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Will be analyzed using mixed-effects linear regression.
Average changes and associated 95% confidence intervals will be estimated from these models.
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Baseline to up to 12 weeks after completion of radiation therapy
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Changes in mindfulness assessed by Freiburg Mindfulness Inventory
Lasso di tempo: Baseline to up to 12 weeks after completion of radiation therapy
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Will be analyzed using mixed-effects linear regression.
Average changes and associated 95% confidence intervals will be estimated from these models.
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Baseline to up to 12 weeks after completion of radiation therapy
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14D.272
- 2013-107 (Altro identificatore: CCRRC)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .
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