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Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

1. April 2020 aktualisiert von: The University of Texas Medical Branch, Galveston

Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior.

The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Increasing and maintaining physical activity among female breast cancer (BC) survivors during treatment remains an unresolved problem in BC survivorship care. BC survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decline of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-less than 30% of survivors met physical activity recommendations. Physical activity interventions have shown effectiveness in helping BC survivors increase activity during treatment, but limited evidence-based activity interventions have been disseminated into the clinic and community. To address this limitation, we are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior, which will investigate the feasibility of implementing active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Participants (N = 60) will be randomized to participate in the support group using the active video game-based physical activity intervention or to participate in the existing UTMB breast cancer support group with pedometers. Our specific aims are:

Aim 1: Evaluate the feasibility and acceptability of active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Measures of feasibility will include weekly attendance records, number of completed home-based worksheets, number of participants completing the program activities, technological issues, and adverse events.

Aim 2: Compare the support group using the active video game-based physical activity intervention to the existing UTMB breast cancer support group with pedometer. Primary outcomes will be changes in physical activity. Secondary outcomes will be changes in physical function, dietary pattern, and quality of life.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Vereinigte Staaten
    • Texas
      • Galveston, Texas, Vereinigte Staaten, 77550
        • The University of Texas Medical Branch

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

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  1. Provide informed consent
  2. Diagnosed with primary female breast cancer within 0 to 6 months period of time
  3. English-speaking between the ages of 18 and 70
  4. Able to read and write in English
  5. Obtained approval from oncologists for the participant to be involved in the physical activity based support group
  6. Able to travel to the UTMB Breast Health Center
  7. Able to move arms and legs as well as ambulate
  8. Able to see TV screen from a distance of 2 to 4 feet

Exclusion Criteria:

  1. Being pregnant
  2. Dementia
  3. Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week
  4. Are involved in another physical activity intervention

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Active video game-based intervention
This arm will receive the active video game-based intervention, which will include attending 12 weekly group sessions at the UTMB Breast Health Clinic, participate in self-paced home session, and monitor daily, weekly, and monthly steps using Wii Fit Meter. All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.
Verhalten: Active video game-based intervention
  • Attend 12 weekly group session at the UTMB Breast Health Clinic to play the active video games using Wii Fit U or Xbox 360.
  • Participate in self-paced home sessions
  • Monitor daily, weekly, and monthly steps using Wii Fit Meter
  • Feedback on physical activity and physical function
Aktiver Komparator: Pedometer
This arm will receive the pedometer intervention, which will include attending 3 monthly UTMB Breast Cancer Support Group sessions, and monitor daily, weekly, and monthly steps using a pedometer (Digit-Walker CW-700/701). All participant will be provided a water bottle and a tote bag as a token of appreciation for participation.
Verhalten: Pedometer
  • Attend 3 monthly UTMB Breast Cancer Support Group Sessions
  • Monitor daily, weekly, and monthly steps using a pedometer (Digi-walker CW-700/701)
  • Feedback on physical activity and physical function

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in physical activity steps per day as measured by an Actigraph monitor
Zeitfenster: Change in steps per day from baseline to 14 weeks
Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor
Change in steps per day from baseline to 14 weeks
Change in physical activity minutes as measured by an Actigraph monitor
Zeitfenster: Change in physical activity minutes from baseline to 14 weeks
Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor
Change in physical activity minutes from baseline to 14 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
Zeitfenster: Change in physical function from baseline and 14 weeks
The SPPB consists of six components: repeated chair sit and stands, balance test, semi-tandem stand, tandem stand, side-by-side stand, and eight feet walk
Change in physical function from baseline and 14 weeks
Change in dietary pattern as measured by the Dietary Screener Questionnaire
Zeitfenster: Change in dietary pattern from baseline and 14 weeks
Change in dietary pattern from baseline and 14 weeks] [Safety Issue: No] The Dietary Screener Questionnaire used in the National Health and Nutrition Examination Survey 2009-10. The screener captures frequency of fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days
Change in dietary pattern from baseline and 14 weeks
Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure
Zeitfenster: Change in quality of life from baseline and 14 weeks
Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B
Change in quality of life from baseline and 14 weeks
Change in hand grip strength as measured by hand dynamometer
Zeitfenster: Change in hand grip strength from baseline to 14 weeks
Hand dynamometer estimates the muscle strength generated from flexor muscles of the hand and the forearm
Change in hand grip strength from baseline to 14 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in weight
Zeitfenster: Change in weight from baseline to 14 weeks
Change in body weight between 14 weeks and baseline as measured by a weight scale in the clinic
Change in weight from baseline to 14 weeks
Change in waist circumference
Zeitfenster: Change in waist circumference from baseline to 14 weeks
Change in waist circumference between 14 weeks and baseline as measured by Seca-203
Change in waist circumference from baseline to 14 weeks
Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors
Zeitfenster: Change in physical activity minutes from baseline to 14 weeks
Self-reported physical activity questionnaire
Change in physical activity minutes from baseline to 14 weeks
Change in physical function, measured by PROMIS measure specific to cancer survivors
Zeitfenster: Change in physical function from baseline to 14 weeks
Changes in overall self-reported physical functions between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Physical Function
Change in physical function from baseline to 14 weeks
Change in fatigue, measured by PROMIS measure specific to cancer survivors
Zeitfenster: Change in fatigue from baseline to 14 weeks
Changes in overall self-reported fatigue level between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Fatigue
Change in fatigue from baseline to 14 weeks
Change in exercise motivation, measured by autonomous motivation specific to physical activity
Zeitfenster: Change in motivation from baseline to 14 weeks
Behavioral regulation in Exercise Questionnaire-2 will be used
Change in motivation from baseline to 14 weeks
Change in psychological feelings, measured by Psychological Need Satisfaction in Exercise Scale
Zeitfenster: Change in psychological feelings from baseline to 14 weeks
Sub-scales included perceived competence, perceived autonomy, and perceived relatedness
Change in psychological feelings from baseline to 14 weeks
Change in self-regulation, measured by Rovinak et al. scale
Zeitfenster: Change in self-regulation from baseline to 14 weeks
Sub-scales include exercise goals and exercise plans
Change in self-regulation from baseline to 14 weeks
Feasibility-Adherence
Zeitfenster: 14 weeks
Adherence will be measured by number of participants who completed at least 80% of the program activities.
14 weeks
Feasibility-Attrition
Zeitfenster: 14 weeks
Attrition will be measured by percentage of people who dropped out of the intervention program.
14 weeks
Feasibility-Technological Issues
Zeitfenster: 14 weeks
Technological issues will be measured by counting number of occurrence
14 weeks
Feasibility-Adverse Events
Zeitfenster: 14 weeks
Adverse events will be measured by counting number of occurrence
14 weeks
Acceptability
Zeitfenster: 14 weeks
Participant acceptability and satisfaction will be assessed by a questionnaire with 5-point scale responses
14 weeks

Mitarbeiter und Ermittler

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

Sponsor

The University of Texas Medical Branch, Galveston

Ermittler

  • Hauptermittler: Maria Swartz, PhD, MPH, The University of Texas Medical Branch

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. April 2016

Primärer Abschluss (Tatsächlich)

1. Januar 2019

Studienabschluss (Tatsächlich)

1. Januar 2019

Studienanmeldedaten

Zuerst eingereicht

18. April 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. April 2016

Zuerst gepostet (Schätzen)

25. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. April 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. April 2020

Zuletzt verifiziert

1. Dezember 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 16-0040

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

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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