Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada
- Rekruttering
- Tom Baker Cancer Centre
-
Grande Prairie, Alberta, Canada
- Rekruttering
- Grande Prairie Cancer Centre
-
Lethbridge, Alberta, Canada
- Rekruttering
- Lethbridge Cancer Centre
-
Medicine Hat, Alberta, Canada
- Rekruttering
- Medicine Hat Cancer Centre
-
Red Deer, Alberta, Canada
- Rekruttering
- Central Alberta Cancer Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
- do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
Studieplan
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 |
|---|---|
|
Eksperimentell: PA Behavior Intervention
Physical Activity Resource Kit
|
The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration). |
|
Aktiv komparator: Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
|
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Self-reported physical activity
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cancer specific health related quality of life
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Psychosocial health outcomes
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Objective step counts (pedometer)
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Chemotherapy completion rate
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Determinants of physical activity
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Physical functioning
Tidsramme: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jeff Vallance, PhD, Athabasca University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PROACTIVE
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