- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03120819
Exercise Information for Women With Cancer
A Randomized Controlled Trial to Determine the Effect of Supplementing an Oncologist's Recommendation to Exercise With Multimedia on Fatigue Levels in Breast Cancer Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Purpose: Controlled, intervention trials suggest that exercise may be a useful strategy to manage symptoms and side effects associated with cancer treatment. However, practical programs that facilitate exercise engagement among cancer patients are few and have been insufficiently studied. Medical providers may be best suited to deliver exercise information because of their frequent patient contact and the trust that patients place in their advice; however, unless sufficient resources are supplied in conjunction with verbal advice, patients may be less likely to successfully follow their physician's advice. The addition of an easy-to-follow, cancer specific exercise instructional video (DVD) to a provider's recommendation to exercise may provide patients with the motivation and ability to increase physical activity. We propose a feasibility study that will 1) determine acceptance and use of a provider-disseminated instructional home-exercise DVD among female cancer patients treated at OHSU and 2) determine if this cancer specific home-based DVD exercise program leads to greater decreases in fatigue, increases in exercise motivation and in physical activity compared to a standard exercise recommendation only among breast cancer patients treated at OHSU (N=100).
Methods: Medical providers who see female cancer patients during routine clinical visits will be approached to participate in the study. Willing providers will be enlisted to consent patients to receive a brief conversation (2-3 minutes) about the importance of exercise in their cancer care and then ask whether or not patients are willing to receive more information about the study from study staff. Providers will inform study staff about consenting participants who will then be randomized to one of two groups in the order that they enrolled. Study staff will then contact participants by phone to further explain the study and confirm eligibility then ask questions about their treatment, symptoms, and physical activity history. Based on their randomly assigned group, participants will receive either a control packet of standard exercise information based on guidelines from the American Cancer Society or standard exercise information plus a cancer specific home-based exercise DVD program. Fatigue, motivation for exercise, physical activity and use / acceptability of exercise information (+/- DVD) will be reassessed at 4 and 8 weeks following enrollment.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- OHSU School of Nursing
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of breast cancer
- Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health & Science University (OHSU)
- Capable of answering survey questions by phone
Exclusion Criteria:
- Not medically cleared to participate in low-intensity exercise
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Oncologist Recommendation only
Medical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit.
Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials.
The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS).
The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services.
|
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
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Sperimentale: Oncologist Recommendation + DVD
Participants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD.
Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation.
The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist.
The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease.
Women are encouraged to use the DVD at least 3 times per week.
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Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Patient-Reported Fatigue
Lasso di tempo: baseline, 4 and 8 weeks
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Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale
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baseline, 4 and 8 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in self-efficacy for exercise
Lasso di tempo: baseline, 4 and 8 weeks
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Self-efficacy for exercise will be measured using the Self-Efficacy Assessment scale modified for exercise
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baseline, 4 and 8 weeks
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Change in exercise readiness assessed by the Stage of Change for exercise
Lasso di tempo: baseline, 4 and 8 weeks
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We will measure a person's readiness to engage in recommended levels of physical activity using the Stage of Change for behavior change modified for exercise
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baseline, 4 and 8 weeks
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Change in self-report physical activity measured with the International Physical Activity Questionnaire
Lasso di tempo: Baseline, 4 and 8 weeks
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We will measure changes in the reported time spent in physical activities per week
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Baseline, 4 and 8 weeks
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Collaboratori e investigatori
Pubblicazioni e link utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IRB00005997
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