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Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

1 april 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Galveston, Texas, Verenigde Staten, 77550
        • The University of Texas Medical Branch

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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
Actieve vergelijker: 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.
Gedragsmatig: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in physical activity steps per day as measured by an Actigraph monitor
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The University of Texas Medical Branch, Galveston

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2016

Primaire voltooiing (Werkelijk)

1 januari 2019

Studie voltooiing (Werkelijk)

1 januari 2019

Studieregistratiedata

Eerst ingediend

18 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

20 april 2016

Eerst geplaatst (Schatting)

25 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 april 2020

Laatste update ingediend die voldeed aan QC-criteria

1 april 2020

Laatst geverifieerd

1 december 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16-0040

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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