The HEALS Project - Health Education and Active Living for Surviving Seniors (HEALS)
9. november 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
63
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Utah
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Salt lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- 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.
- 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.
- Able to speak and read English fluently, and understand informed consent.
- Willing to: sign a medical record release form; to be randomized and willing to participate in classes and all baseline and follow-up appointments.
- 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.
- Does not currently practice in a regular on-going meditative or relaxation technique.
- 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:
- 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.
- 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.
- Inability to pass the Folstein Mini Mental Status Exam (score <23).
- Unable to drive or secure transportation to complete all aspects of the study.
- Health conditions (e.g. severe hearing loss, respiratory, cardiovascular, or neurological problems) that might interfere with the required intervention.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
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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.).
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Retention Rates and Class Attendance
Tidsramme: 13 weeks
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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)
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13 weeks
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Satisfaction With the Randomized Controlled Trial
Tidsramme: 13 weeks
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The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).
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13 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Health-Related Quality of Life (Short Form (SF)-36v1)
Tidsramme: 13 weeks
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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.
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13 weeks
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Perceived Stress Scale
Tidsramme: 13 weeks
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The 10-item perceived stress scale produces a summation score.
Scores can range from 0 to 40, with higher scores indicating more stress.
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13 weeks
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Impact of Events Scale
Tidsramme: 13-weeks
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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.
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13-weeks
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Pittsburgh Sleep Quality Index
Tidsramme: 13-weeks
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The Pittsburgh Sleep Quality produces a global score.
The range is 0 to 21, higher scores indicate worse sleep quality.
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13-weeks
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Five-Facet Mindfulness Questionnaire
Tidsramme: 13-weeks
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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.
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13-weeks
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Blood Pressure
Tidsramme: 13-weeks
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Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.
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13-weeks
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Cortisol Area-Under-Curve (AUC)
Tidsramme: 13-weeks
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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.
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13-weeks
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Inflammatory Cytokines
Tidsramme: 13-weeks
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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.
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13-weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Anita Kinney, Huntsman Cancer Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2009
Primær fullføring (Faktiske)
1. september 2011
Studiet fullført (Faktiske)
1. november 2011
Datoer for studieregistrering
Først innsendt
18. februar 2011
Først innsendt som oppfylte QC-kriteriene
24. februar 2011
Først lagt ut (Anslag)
28. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 34851
- R21 CA135250-2 (Annet stipend/finansieringsnummer: NCI)
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