Quality of Life Interventions During Cervical Cancer Treatment
25 maggio 2021 aggiornato da: Susan Lutgendorf, University of Iowa
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression.
This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
60
Fase
- Non applicabile
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
Da 18 anni a 100 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion Criteria:
- Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.
Exclusion Criteria:
- Greater than Stage IVa cervical cancer
- Metastatic or recurrent cervical cancer
- Patients receiving only chemotherapy or only radiation therapy
- History of cancer of any site
- History of a transplant
- Diagnosed with any immunosupressive disorder (HIV, AIDS).
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: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Relaxation training following daily radiation
All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants.
Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery
|
Muscle relaxation training
Altri nomi:
Subjects in all groups will give 4 blood samples during the study
Altri nomi:
|
|
Sperimentale: Healing touch therapy following daily radiation
All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants.
Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.
|
Subjects in all groups will give 4 blood samples during the study
Altri nomi:
Healing Touch (HT) therapy
Altri nomi:
|
|
Comparatore attivo: No intervention
The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.
|
Subjects in all groups will give 4 blood samples during the study
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in natural killer cell cytotoxicity (NKCC)
Lasso di tempo: 6 weeks
|
Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay. |
6 weeks
|
|
Number of chemoradiation-related toxicities
Lasso di tempo: 6 weeks
|
Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0
|
6 weeks
|
|
Number of days of treatment delay due to chemoradiation-related toxicities
Lasso di tempo: 6 weeks
|
Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care
|
6 weeks
|
|
Change in participant reports of depression
Lasso di tempo: 6 weeks
|
Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)
|
6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in participant reports of anxiety
Lasso di tempo: 6 weeks
|
Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)
|
6 weeks
|
|
Change in white blood cell counts
Lasso di tempo: 6 weeks
|
Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. |
6 weeks
|
|
Change in red blood cell counts
Lasso di tempo: 6 weeks
|
Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.
|
6 weeks
|
|
Change in participant reports of quality of life
Lasso di tempo: 6 weeks
|
Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT).
Higher scores indicate better quality of life.
Range= (0-136).
|
6 weeks
|
|
Change in participant reports of fatigue
Lasso di tempo: 6 weeks
|
Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI).
Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.
|
6 weeks
|
|
Change in metabolomic measures
Lasso di tempo: 6 weeks
|
Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care.
Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS).
The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc.
For any specific metabolite, higher levels indicates greater presence of the metabolite.
|
6 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Susan Lutgendorf, PhD, University of Iowa
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.
- Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.
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)
4 giugno 2001
Completamento primario (Effettivo)
15 marzo 2008
Completamento dello studio (Effettivo)
1 luglio 2014
Date di iscrizione allo studio
Primo inviato
20 maggio 2021
Primo inviato che soddisfa i criteri di controllo qualità
25 maggio 2021
Primo Inserito (Effettivo)
27 maggio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 maggio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 maggio 2021
Ultimo verificato
1 maggio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 200105058
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
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 .