- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04905576
Quality of Life Interventions During Cervical Cancer Treatment
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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
Andere Namen:
Subjects in all groups will give 4 blood samples during the study
Andere Namen:
|
Experimental: 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
Andere Namen:
Healing Touch (HT) therapy
Andere Namen:
|
Aktiver Komparator: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in natural killer cell cytotoxicity (NKCC)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in participant reports of anxiety
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Susan Lutgendorf, PhD, University of Iowa
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 200105058
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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