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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Oregon
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Portland, Oregon, États-Unis, 97239
- OHSU School of Nursing
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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.
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Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Patient-Reported Fatigue
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in self-efficacy for exercise
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB00005997
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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