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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Alberta
-
Calgary, Alberta, Kanada
- Rekrytering
- Tom Baker Cancer Centre
-
Grande Prairie, Alberta, Kanada
- Rekrytering
- Grande Prairie Cancer Centre
-
Lethbridge, Alberta, Kanada
- Rekrytering
- Lethbridge Cancer Centre
-
Medicine Hat, Alberta, Kanada
- Rekrytering
- Medicine Hat Cancer Centre
-
Red Deer, Alberta, Kanada
- Rekrytering
- Central Alberta Cancer Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Self-reported physical activity
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cancer specific health related quality of life
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Psychosocial health outcomes
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Objective step counts (pedometer)
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Chemotherapy completion rate
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Determinants of physical activity
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Physical functioning
Tidsram: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jeff Vallance, PhD, Athabasca University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PROACTIVE
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