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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Alberta
-
Calgary, Alberta, Kanada
- Rekrutierung
- Tom Baker Cancer Centre
-
Grande Prairie, Alberta, Kanada
- Rekrutierung
- Grande Prairie Cancer Centre
-
Lethbridge, Alberta, Kanada
- Rekrutierung
- Lethbridge Cancer Centre
-
Medicine Hat, Alberta, Kanada
- Rekrutierung
- Medicine Hat Cancer Centre
-
Red Deer, Alberta, Kanada
- Rekrutierung
- Central Alberta Cancer Centre
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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). |
|
Aktiver 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Self-reported physical activity
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Cancer specific health related quality of life
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Psychosocial health outcomes
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Objective step counts (pedometer)
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Chemotherapy completion rate
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Determinants of physical activity
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Physical functioning
Zeitfenster: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jeff Vallance, PhD, Athabasca University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PROACTIVE
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