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Physical Activity for Adolescent and Young Adult Cancer Survivors

29 de mayo de 2019 actualizado por: Jennifer Brunet, University of Ottawa

Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention

More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

17

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

    • Ontario
      • Ottawa, Ontario, Canadá, K1N 6N5
        • University of Ottawa

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

15 años a 44 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

INCLUSION CRITERIA:

  1. Have been diagnosed with cancer for the first time between the ages of 15 and 39 years;
  2. Have completed cancer treatment within 5 years;
  3. Currently between the ages of 15 to 44 years;
  4. Have no current evidence of progressive disease, secondary cancer (i.e., cancer cells that have spread from the primary cancer), or second cancers (i.e., a new different cancer);
  5. Live within 100 km of the University of Ottawa;
  6. Be inactive or insufficiently active as determined by a single item screening question (i.e., participants must respond "no" to the following question: are you currently engaging in moderate physical activity, defined as activity that increases your heart rate and causes you to sweat, on 3 or more days a week?). Screening participants based on their level of physical activity will ensure only those individuals for whom the intervention will have the largest effect are recruited;
  7. Able to read, understand, and provide informed consent in English;
  8. Ready for physical activity as indicated by answering Physical Activity Readiness Questions (PAR-Q). If participants are not ready for physical activity as determined by the PAR-Q they will need to complete a Physical Activity Readiness Medical Examination Form.

EXCLUSION CRITERIA:

  1. Physical impairments precluding participation in physical activity;
  2. Unwilling or unable to sign the Participant Informed Consent Form;
  3. Received a diagnosis of brain cancer or thyroid cancer. Brain cancer survivors will be excluded as a function of the cognitive impairments associated with their diagnosis and treatment and thyroid cancer survivors will be excluded due to the vastly different treatment regimens. That is, both of these cancers may result in different physical, psychological/emotional, and social effects that could impact the outcomes of interest.

Eligible participants who want to participate in the other pre-specified outcome measures to assess cognitive functioning must also meet the following additional inclusion/exclusion criteria.

ADDITIONAL INCLUSION CRITERIA:

  1. Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during fMRI tasks;
  2. Able to read, understand, and provide informed consent in English for the additional assessments.

ADDITIONAL EXCLUSION CRITERIA:

  1. Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
  2. Claustrophobia;
  3. Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
  4. Lower back pain that would preclude a person from lying relatively still for one hour;
  5. Substance use disorder as assessed by a single item question (i.e., participants must respond "no" to the following question: Have you been told, in the last five years, by your healthcare provider that you have a substance use disorder?).

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Physical Activity
Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.
Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
Sin intervención: Wait-List Control
Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment Rates
Periodo de tiempo: Through study completion, an average of 12-24 weeks
The number of eligible participants who enrol in the study out of the number who are referred.
Through study completion, an average of 12-24 weeks
Retention Rates
Periodo de tiempo: Through study completion, an average of 12-24 weeks
The number of participants completing the intervention and all scheduled assessments.
Through study completion, an average of 12-24 weeks
Adherence Rates
Periodo de tiempo: Through study completion, an average of 12-24 weeks
The number of physical activity sessions engaged in out of the total recommended as part of the intervention.
Through study completion, an average of 12-24 weeks
Number of Participants with Adverse Events
Periodo de tiempo: Through study completion, an average of 12-24 weeks
The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.
Through study completion, an average of 12-24 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Physical Activity Behaviour: Daily Physical Activity Logbook
Periodo de tiempo: Through study completion, an average of 12-24 weeks
Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Through study completion, an average of 12-24 weeks
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Physical Activity Behaviour: 7-Day Accelerometer Wear (Objective Physical Activity Behaviour)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12), follow-up (week 24)
Resting Heart Rate
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Blood Pressure
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Body Composition: Body Mass Index
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (CSEP, 2013; Irwin, 2012)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength using a Handheld Dynamometer (CSEP, 2013; Irwin, 2012)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Muscular Endurance: 30-Second Sit to Stand Test (Rikli & Jones, 2001)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Self-Efficacy: Single-Item Version of the Exercise Self-Efficacy Scale (McAuley, 1993)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Physical Competence and Physical Self-Esteem: Physical Self-Description Questionnaire Short-Form Appearance, Strength, Endurance, Body Fat, and Physical Self-Esteem scales (Marsh, Martin, & Jackson, 2010)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Global Self-Esteem: Rosenberg Global Self-Esteem Scale (Rosenberg, 1965)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Body Image: Multidimensional Body-Self Relations Questionnaire Appearance Evaluation and Body Areas Satisfaction scales (Cash, 2000)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Posttraumatic Growth: Posttraumatic Growth Inventory (Tedeschi & Calhoun, 1996)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Quality of Life: Medical Outcomes Study 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992)
Periodo de tiempo: Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.
Baseline (week 0), mid-intervention (weeks 6), post-intervention (week 12)
Participants Experiences: Qualitative Interviews
Periodo de tiempo: Baseline (week 0), post-intervention (week 12)
Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.
Baseline (week 0), post-intervention (week 12)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cognitive Functioning: Single Open-Ended Question
Periodo de tiempo: Baseline (week 0), post-intervention (week 12), follow-up (week 24)

Change in participants responses to a single open-ended question: "Do you ever feel like you have a hard time thinking and/or remembering?" from baseline, to post-intervention, to follow-up.

NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.

Baseline (week 0), post-intervention (week 12), follow-up (week 24)
Cognitive Functioning: Magnetic Resonance Imaging (MRI) Scans
Periodo de tiempo: Baseline (week 0), post-intervention (week 12), follow-up (week 24)

Change in participants cognitive functioning, as assessed by a structural scan, a resting state functional MRI (fMRI) procedure, four fMRI tasks, and a diffusion tensor imaging sequence (lasting approximately 60 minutes), from baseline, to post-intervention, to follow-up.

NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.

Baseline (week 0), post-intervention (week 12), follow-up (week 24)
Socio-Demographic and Medical Information Questionnaire
Periodo de tiempo: Baseline (week 0)
The socio-demographic and medical information collected will be used to describe the sample.
Baseline (week 0)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Jennifer Brunet, PhD, University of Ottawa

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

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 (Actual)

11 de septiembre de 2017

Finalización primaria (Actual)

16 de abril de 2019

Finalización del estudio (Actual)

5 de mayo de 2019

Fechas de registro del estudio

Enviado por primera vez

24 de diciembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

6 de enero de 2017

Publicado por primera vez (Estimar)

11 de enero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Ottawa

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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