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

9. november 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

63

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Utah
      • Salt lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Aktiv 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.).
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retention Rates and Class Attendance
Tidsramme: 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
Tidsramme: 13 weeks
The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
13 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-Related Quality of Life (Short Form (SF)-36v1)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 13-weeks
Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
13-weeks
Cortisol Area-Under-Curve (AUC)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

Samarbejdspartnere

National Cancer Institute (NCI)
Huntsman Cancer Institute

Efterforskere

  • Ledende efterforsker: Anita Kinney, Huntsman Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2009

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

18. februar 2011

Først indsendt, der opfyldte QC-kriterier

24. februar 2011

Først opslået (Skøn)

28. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 34851
  • R21 CA135250-2 (Andet bevillings-/finansieringsnummer: NCI)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livskvalitet

Kliniske forsøg med Tai Chi Chih

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Thailand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner