Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

1 aprile 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Galveston, Texas, Stati Uniti, 77550
        • The University of Texas Medical Branch

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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
Comparatore attivo: 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.
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in physical activity steps per day as measured by an Actigraph monitor
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 14 weeks
Adherence will be measured by number of participants who completed at least 80% of the program activities.
14 weeks
Feasibility-Attrition
Lasso di tempo: 14 weeks
Attrition will be measured by percentage of people who dropped out of the intervention program.
14 weeks
Feasibility-Technological Issues
Lasso di tempo: 14 weeks
Technological issues will be measured by counting number of occurrence
14 weeks
Feasibility-Adverse Events
Lasso di tempo: 14 weeks
Adverse events will be measured by counting number of occurrence
14 weeks
Acceptability
Lasso di tempo: 14 weeks
Participant acceptability and satisfaction will be assessed by a questionnaire with 5-point scale responses
14 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Texas Medical Branch, Galveston

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2016

Completamento primario (Effettivo)

1 gennaio 2019

Completamento dello studio (Effettivo)

1 gennaio 2019

Date di iscrizione allo studio

Primo inviato

18 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

20 aprile 2016

Primo Inserito (Stima)

25 aprile 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 aprile 2020

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 16-0040

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro al seno

Prove cliniche su Active video game-based intervention

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Malawi

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi