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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alberta
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Calgary, Alberta, Canada
- Werving
- Tom Baker Cancer Centre
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Grande Prairie, Alberta, Canada
- Werving
- Grande Prairie Cancer Centre
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Lethbridge, Alberta, Canada
- Werving
- Lethbridge Cancer Centre
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Medicine Hat, Alberta, Canada
- Werving
- Medicine Hat Cancer Centre
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Red Deer, Alberta, Canada
- Werving
- Central Alberta Cancer Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: PA Behavior Intervention
Physical Activity Resource Kit
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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). |
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Actieve vergelijker: Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
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Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Self-reported physical activity
Tijdsspanne: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Cancer specific health related quality of life
Tijdsspanne: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Psychosocial health outcomes
Tijdsspanne: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Objective step counts (pedometer)
Tijdsspanne: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Chemotherapy completion rate
Tijdsspanne: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Determinants of physical activity
Tijdsspanne: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Physical functioning
Tijdsspanne: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jeff Vallance, PhD, Athabasca University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PROACTIVE
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