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The HEALS Project - Health Education and Active Living for Surviving Seniors (HEALS)

9. November 2015 aktualisiert von: Anita Kinney, University of Utah

Biobehavioral Effects of Tai Chi Chih Among Elderly Female Cancer Survivors

Persons over age 65 years constitute a large and growing population of cancer survivors. Available data indicate that both short- and long-term female breast cancer survivors report more limitations related to strength and mobility than women with cancers of other sites and women without a personal history of cancer. Further, better mental health among breast cancer survivors has been shown to protect against physical decline and overall quality of life. The combination of mental and physical interventions may result in substantial improvements in quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention. TCC may be particularly suited toward elderly breast cancer survivors with impaired physical and/or mental functioning, yet despite its increasing popularity and benefits in healthy and diseased populations, its benefits have never been scientifically evaluated in this population. The overarching goal of this study is to conduct preparatory work regarding the effects of TCC on quality of life and physical function that will underpin future definitive trials of TCC in elderly cancer survivors. As part of this 12-week trial, participants will be randomized to a TCC or a health education control group (HEC). Establishment of meaningful interventions that facilitate a more positive cancer survival experience in old age is an important issue; there are substantial public health and clinical benefits should a TC intervention be successful in this patient population.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

63

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Utah
      • Salt lake City, Utah, Vereinigte Staaten, 84112
        • Huntsman Cancer Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

55 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  1. Age >/= 55 years and it has been three months or more (with the exception of hormone therapy) since completing treatment for breast or other solid tumor cancers (excluding lung, liver, pancreas and brain) and currently in remission.
  2. Living within 30 miles of Huntsman Cancer Institute and has access to transportation and is willing to travel to the study site per study protocol; Travels independently on public transportation or drives own car.
  3. Able to speak and read English fluently, and understand informed consent.
  4. Willing to: sign a medical record release form; to be randomized and willing to participate in classes and all baseline and follow-up appointments.
  5. Has some physical limitation as defined by a score of <72 in the Role Physical or <80 in the Physical Functioning sub-scales in the SF-12 screening questionnaire.
  6. Does not currently practice in a regular on-going meditative or relaxation technique.
  7. Does not currently engage in a regular, strenuous-intensity form of exercise for 30 min or more per day, 3 or more days per week.

Exclusion Criteria:

  1. Engaged in focused intense physical activity for 30 minutes or more a day for 3 or more days a week for the previous 6 months as per responses on the screening telephone call.
  2. Regular on-going practice with TC or other similar types of Complementary and Alternative Medicine in the past 6 months such as Qigong, meditation, relaxation, and yoga since these share some of the principles of TC.
  3. Inability to pass the Folstein Mini Mental Status Exam (score <23).
  4. Unable to drive or secure transportation to complete all aspects of the study.
  5. Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

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: Tai Chi Chih
The Tai Chi Chih classes were 60 minutes sessions, held three times a week, over twelve weeks. The classes were led by an instructor who was certified and licensed in the Tai Chi Chih form.
Verhalten: Tai Chi Chih
Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
Aktiver Komparator: Health Education Classes
Health Education classes were 60 minute sessions that occurred three times a week, over twelve weeks. These classes were taught by specialists in the class topic and focused on topics related to aging (e.g., sleep quality, nutrition, pain, etc.).
Verhalten: Health Education Classes
The Health Education classes serve as an attention control group, are led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Retention Rates and Class Attendance
Zeitfenster: 13 weeks
The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)
13 weeks
Satisfaction With the Randomized Controlled Trial
Zeitfenster: 13 weeks
The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
13 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Health-Related Quality of Life (Short Form (SF)-36v1)
Zeitfenster: 13 weeks
SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100. Higher scores indicate better quality of life.
13 weeks
Perceived Stress Scale
Zeitfenster: 13 weeks
The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.
13 weeks
Impact of Events Scale
Zeitfenster: 13-weeks
The Impact of Event Scale assesses cancer-specific distress. Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact. It has a total score and two subscales (avoidance & intrusion). The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales. The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40. The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.
13-weeks
Pittsburgh Sleep Quality Index
Zeitfenster: 13-weeks
The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.
13-weeks
Five-Facet Mindfulness Questionnaire
Zeitfenster: 13-weeks
The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity). These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35). Higher scores indicate more mindfulness. The Total Score ranges from 39-195, with higher scores indicating more mindfulness.
13-weeks
Blood Pressure
Zeitfenster: 13-weeks
Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
13-weeks
Cortisol Area-Under-Curve (AUC)
Zeitfenster: 13-weeks
Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion. Cortisol was measured in nmol/L. Cortisol AUC was calculated using the five timepoints with the trapezoid rule. The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means. Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.
13-weeks
Inflammatory Cytokines
Zeitfenster: 13-weeks
Fasting blood samples were collected in the morning for inflammatory cytokines. Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw. The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.
13-weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Utah

Mitarbeiter

National Cancer Institute (NCI)
Huntsman Cancer Institute

Ermittler

  • Hauptermittler: Anita Kinney, Huntsman Cancer Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2009

Primärer Abschluss (Tatsächlich)

1. September 2011

Studienabschluss (Tatsächlich)

1. November 2011

Studienanmeldedaten

Zuerst eingereicht

18. Februar 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Februar 2011

Zuerst gepostet (Schätzen)

28. Februar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

14. Dezember 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2015

Zuletzt verifiziert

1. November 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 34851
  • R21 CA135250-2 (Andere Zuschuss-/Finanzierungsnummer: NCI)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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