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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
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Alberta
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Calgary, Alberta, Canada
- Reclutamento
- Tom Baker Cancer Centre
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Grande Prairie, Alberta, Canada
- Reclutamento
- Grande Prairie Cancer Centre
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Lethbridge, Alberta, Canada
- Reclutamento
- Lethbridge Cancer Centre
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Medicine Hat, Alberta, Canada
- Reclutamento
- Medicine Hat Cancer Centre
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Red Deer, Alberta, Canada
- Reclutamento
- Central Alberta Cancer Centre
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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). |
|
Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Self-reported physical activity
Lasso di tempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Cancer specific health related quality of life
Lasso di tempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Psychosocial health outcomes
Lasso di tempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Objective step counts (pedometer)
Lasso di tempo: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Chemotherapy completion rate
Lasso di tempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Determinants of physical activity
Lasso di tempo: Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Physical functioning
Lasso di tempo: Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jeff Vallance, PhD, Athabasca University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PROACTIVE
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