- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01441011
Rural Women Connecting for Better Health
22 de noviembre de 2016 actualizado por: University of Kansas Medical Center
Group Phone-Based Weight Control for Rural Breast Cancer Survivors
Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts.
Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death.
Rural women suffer from health disparities in breast cancer diagnosis and treatment.
Women of the most rural counties also have the highest prevalence of obesity compared to urban women.
To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors.
Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women.
This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity.
However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown.
Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence.
This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions.
In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Phase 1 - Weight Loss (0-6 months)
- Weekly group phone counseling sessions for all participants (12-14 women per group) via conference call for 26 consecutive weeks
- Low-calorie, low-fat diet recommended, including 2 pre-packaged entrees, five one-cup servings of fruits and vegetables and meal replacement shakes (provided free of charge)
- Physical activity program program recommended, beginning with 15 minutes per day, 3 days a week, working toward a goal of 225 minutes a week
- Experienced group counselor facilitates all sessions
Phase 2 - Weight Loss Maintenance (6-18 months)
- Participants randomized to either group phone counseling or mail-based comparison with no phone counseling
- Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while mail-based comparison includes 26 bi-weekly newsletters in the mail
- Focus is on problem-solving
Phase 3 - Transition to Self-Reliance (18-24 months)
- Lasts from 18-24 months
- No sessions or newsletter mailings
- Participants are encouraged to continue to self-monitor throughout this period
Tipo de estudio
Intervencionista
Inscripción (Actual)
210
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 75 años (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Breast cancer patients with a BMI 27-45 kg/m2
- Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated with mastectomy only)
- Have completed all local and systemic therapy at least 3 months prior to entry
- Have clearance from their oncologist or current medical provider to participate in a weight control study
- Must be ≤ 75 years old
- Post-menopausal
- Participants must live in a rural area
- Have access to a phone
- Able to participate in the physical activity component of the intervention, i.e., be able to walk briskly unassisted and without serious medical risk
- Weight stable within ten pounds three months prior to entry
Exclusion Criteria:
- Women with insulin-dependent diabetes
- Ongoing participation in a formal weight loss program
- Ongoing use of pharmacotherapy for weight loss
- Ongoing use of medications that seriously affect weight and metabolism (e.g., steroids, phentermine)
- Positive screen for current substance abuse, major depression, or binge eating disorder
- Any cardiac or pulmonary disease preventing participation
- Treatment for any other cancers within the past year
- Previous bariatric surgery
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group (GRP) phone counseling
The group phone counseling includes 26 bi-weekly phone sessions from 6 to 18 months and focuses on group problem-solving.
Women continue in the same group as in weight loss intervention phase.
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Bi-weekly phone counseling sessions from 6 - 18 months
|
|
Comparador activo: Mail-based Comparison Condition
Participants in this group will receive a newsletter by mail every other week for 12 months starting after the initial 6 month weight loss period.
The newsletters will provide problem-solving tips and will review nutrition and physical activity information.
|
Bi-weekly newsletter mailings from 6 - 18 months
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight loss maintenance
Periodo de tiempo: 6 - 18 months
|
Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors.
|
6 - 18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life
Periodo de tiempo: Baseline and 6, 12, 18, and 24 months
|
Compare the effects of treatment conditions on aspects of quality of life important for breast cancer survivorship, including general physical, social, and emotional well-being, fatigue, arthralgia, lymphedema symptoms, menopausal symptoms, and depressive symptoms.
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Baseline and 6, 12, 18, and 24 months
|
|
Breast cancer risk biomarkers
Periodo de tiempo: Baseline and 6 and 18 months
|
Examine the association of weight change with changes in selected breast cancer risk biomarkers, including bioavailable estradiol, testosterone, and fasting insulin.
Examine whether modulation of biomarkers is sustained during weight loss maintenance.
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Baseline and 6 and 18 months
|
|
Cost effectiveness
Periodo de tiempo: 18 months
|
Compare the incremental cost-effectiveness of weight loss maintenance (kg below baseline) between group and control conditions.
Costs include fixed and variable provider costs (facility, time, phone charges, supplies) and fixed and variable participant costs (time, out-of-pocket expenses).
|
18 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christie Befort, Ph.D., University of Kansas Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Fazzino TL, Fabian C, Befort CA. Change in Physical Activity During a Weight Management Intervention for Breast Cancer Survivors: Association with Weight Outcomes. Obesity (Silver Spring). 2017 Nov;25 Suppl 2(Suppl 2):S109-S115. doi: 10.1002/oby.22007.
- Fazzino TL, Fleming K, Befort C. Alcohol Intake Among Breast Cancer Survivors: Change in Alcohol Use During a Weight Management Intervention. JMIR Cancer. 2016 Nov 9;2(2):e15. doi: 10.2196/cancer.6295.
- Fazzino TL, Sporn NJ, Befort CA. A qualitative evaluation of a group phone-based weight loss intervention for rural breast cancer survivors: Themes and mechanisms of success. Support Care Cancer. 2016 Jul;24(7):3165-73. doi: 10.1007/s00520-016-3149-7. Epub 2016 Mar 2.
- Befort CA, Klemp JR, Fabian C, Perri MG, Sullivan DK, Schmitz KH, Diaz FJ, Shireman T. Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors. Contemp Clin Trials. 2014 Mar;37(2):261-71. doi: 10.1016/j.cct.2014.01.010. Epub 2014 Jan 31.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2011
Finalización primaria (Actual)
1 de abril de 2015
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
23 de septiembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
26 de septiembre de 2011
Publicado por primera vez (Estimar)
27 de septiembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
22 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12633
- 1R01CA155014-01A1 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .