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Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

1 april 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Galveston, Texas, Förenta staterna, 77550
        • The University of Texas Medical Branch

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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
Aktiv 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.
Beteende: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in physical activity steps per day as measured by an Actigraph monitor
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Texas Medical Branch, Galveston

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2016

Primärt slutförande (Faktisk)

1 januari 2019

Avslutad studie (Faktisk)

1 januari 2019

Studieregistreringsdatum

Först inskickad

18 april 2016

Först inskickad som uppfyllde QC-kriterierna

20 april 2016

Första postat (Uppskatta)

25 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 april 2020

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 16-0040

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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