Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy
14 de septiembre de 2026 actualizado por: University of Oklahoma
Physical activity can improve health-related quality of life among people receiving cancer treatment.
Yet, chemotherapy imposes considerable barriers to maintaining an active lifestyle.
Emotion regulation-based approaches based on principles from Self-Determination Theory (SDT) and Acceptance and Commitment Therapy (ACT) may help people engage in physical activity despite treatment-related challenges.
We aimed to develop and conduct a proof of concept study among people initiating chemotherapy for breast and gynecologic cancers to develop and assess the feasibility and acceptability of a novel, mobile health physical activity intervention that drew from SDT and ACT principles.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
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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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion criteria:
- Having ever received a histologically confirmed diagnosis of invasive breast or gynecologic carcinoma (eligible cancer types include epithelial ovarian carcinoma, endometrial/uterine carcinoma, and invasive cervical carcinoma; other rare gynecologic malignancies [e.g., vaginal, vulvar] may also be included if explicitly approved by the study team)
- Scheduled to receive cytotoxic chemotherapy for a minimum of 4 consecutive weeks but not yet begun or are within 4 weeks of having started their chemotherapy for cancer
- Ability to speak and read English
- Having internet access
- Being willing and able to use a smartphone and web interface with or without assistance. If assistance is needed, it must be readily available
- Adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report
- Adequate motor capacity to use a smartphone and web interface as indicated by self-report
- Willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes
Exclusion criteria:
- Eastern Cooperative Oncology Group test score > 2
- Having unstable bone metastases
- Untreated brain metastases
- Contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease)
- Having a body mass index under 18
- Major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study
- Having arthritic or orthopedic issues that would preclude physical exercise
- Another member of the household is a primary participant or staff member on this trial
- Being a prisoner
- Living in an assisted living facility or nursing home
- Enrolled in hospice
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
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This intervention will be delivered over the course of up to 8-12 weeks.
It will include: 1) the provision of a wearable physical activity tracker 2) empirically supported behavior change techniques for promoting physical activity 3) Acceptance and Commitment Therapy-informed didactic content centered on promoting physical activity 4) a social component with game design elements reflecting acceptance and mindfulness practices (i.e., the ability to share responses to "Weekly Challenges" and view and comment on others' entries).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Facilidad de uso percibida
Periodo de tiempo: Semana 9
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Se utilizarán preguntas de validez aparente para determinar si los participantes encontraron las intervenciones fáciles de usar.
Las preguntas de validez aparente constan de cinco ítems tipo Likert de 7 puntos.
Las respuestas van desde "Nada Fácil" (puntuada como 1) hasta "Muy Fácil" (puntuada como 7).
Las puntuaciones más altas reflejan una mayor facilidad de uso.
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Semana 9
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Utilidad Percibida
Periodo de tiempo: Semana 9
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Se utilizarán preguntas de validez aparente para determinar si los participantes encontraron útiles las intervenciones.
Las preguntas de validez aparente constan de cinco ítems tipo Likert de 7 puntos.
Las respuestas van desde "Nada Útil" (puntuado como 1) hasta "Muy Útil" (puntuado como 7).
Las puntuaciones más altas reflejan una mayor utilidad percibida.
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Semana 9
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Disfrutabilidad - Subescala de Interés/Disfrute
Periodo de tiempo: Semana 9
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La subescala interés/disfrute del Inventario de Motivación Intrínseca (IMIe) se utilizará para evaluar la capacidad de disfrute de las intervenciones en este estudio.
La subescala IMIe consta de siete ítems tipo Likert de 7 puntos.
Las respuestas van desde "Nada Cierto" (puntuado como 1) hasta "Muy Cierto" (puntuado como 7).
Las puntuaciones más altas reflejan mayor capacidad de disfrute.
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Semana 9
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Factibilidad del Programa - Retención del Estudio
Periodo de tiempo: Semana 9
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Evaluaremos la viabilidad del programa mediante mediciones de la retención del estudio.
Calcularemos qué porcentaje de participantes inscritos completan los procedimientos de recolección de datos posteriores a la intervención.
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Semana 9
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Viabilidad del Programa - Adherencia
Periodo de tiempo: Semana 9
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Evaluaremos la viabilidad del programa mediante mediciones de adherencia a la intervención.
Calcularemos el porcentaje de participantes que se involucran con al menos el 75% de los módulos de intervención.
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Semana 9
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Viabilidad de la Recolección de Muestras Biológicas
Periodo de tiempo: Semana 9
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Evaluaremos la viabilidad de evaluar la expresión génica en el presente contexto mediante la evaluación del porcentaje de participantes inscritos que proporcionan datos analizables en las extracciones de sangre opcionales posteriores a la intervención.
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Semana 9
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Semi-structured Interviews
Periodo de tiempo: 9 weeks
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Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.
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9 weeks
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Enjoyability
Periodo de tiempo: Week 9
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Face valid questions will be used to assess the enjoyability of the interventions in this study.
The face valid questions consists of five 7-point Likert-type items.
Responses range from "Not At All Enjoyable" (scored as 1) to "Very Enjoyable" (scored as 7).
Higher scores reflect greater enjoyability.
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Week 9
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feelings of Vitality
Periodo de tiempo: Week 9
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The Subjective Vitality Scale (SVS) will be used to will be used to assess participants' feelings of vitality.
The SVS consists of seven 7-point Likert-type items.
Responses range from "Not At All True" (scored as 1) to "Very True" (scored as 7).
Higher scores reflect greater enjoyability.
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Week 9
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Meaning Salience
Periodo de tiempo: Week 9
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The Meaning Awareness Scale (MAS) will be used to assess meaning salience.
The MAS consists of six 7-point Likert-type items.
Responses range from "Very Rarely" (scored as 1) to "Very Often" (scored as 7).
Higher scores reflect greater meaning salience.
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Week 9
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Psychological flexibility
Periodo de tiempo: Week 9
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The Personalized Psychological Flexibility Index (PPFI) will be used to assess psychological flexibility.
The PPFI consists of sixteen 7-point Likert-type items.
Responses range from "Strongly Disagree" (scored as 1) to "Strongly Agree" (scored as 7).
Higher scores reflect greater psychological flexibility.
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Week 9
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Physical activity motivation
Periodo de tiempo: Week 9
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The Behavioral Regulation for Exercise Questionnaire-4 (BREQ-4) will be used to assess physical activity motivation.
The BREQ-4 consists of twenty-eight 5-point Likert-type items.
Responses range from "Not True For Me" (scored as 0) to "Very True For Me" (scored as 4).
It is best practice to score each of the seven subscales separately (i.e., obtain separate scores for amotivation, external regulation, introjected avoidance regulation, introjected approach regulation, identified regulation, integrated regulation, and intrinsic regulation).
For each subscale, higher scores reflect greater usage of that type of regulation.
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Week 9
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Physical Activity Acceptance
Periodo de tiempo: Week 9
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The Physical Activity Acceptance Questionnaire (PAAQ) will be used to assess physical activity acceptance.
The PAAQ consists of ten 7-point Likert-type items.
Responses range from "Never True" (scored as 1) to "Always True" (scored as 7).
It is best practice to score each of the two subscales separately (i.e., obtain separate scores for cognitive acceptance and behavioral commitment).
For each subscale, higher scores reflect greater acceptance/commitment.
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Week 9
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Health-Related Quality of Life - Physical Function
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life. The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity). The physical function subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Unable To Do" (scored as 1) to "Without Any Difficulty" (scored as 5). Higher scores for physical function are favorable. Time Frame: Baseline; Week 9 |
Week 9
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Health-Related Quality of Life - Anxiety
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The anxiety subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Never" (scored as 1) to "Always" (scored as 5).
Higher scores for anxiety are not favorable.
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Week 9
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Health-Related Quality of Life - Depressive Symptoms
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The depressive symptoms subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Never" (scored as 1) to "Always" (scored as 5).
Higher scores for depressive symptoms are not favorable.
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Week 9
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Health-Related Quality of Life - Fatigue
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The fatigue subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for fatigue are not favorable.
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Week 9
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Health-Related Quality of Life - Sleep Disturbance
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The sleep disturbance subscale has 4 items with 5 point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores indicate more sleep disturbance.
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Week 9
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Health-Related Quality of Life - Ability to Participate in Social Roles and Activities
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The ability to participate in social roles and activities subscale has 4 items with 5 point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for ability to participate in social roles and activities are not favorable.
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Week 9
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Health-Related Quality of Life - Pain Interference
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The pain interference subscale has 4 items with 5 point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for pain interference are not favorable.
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Week 9
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Health-Related Quality of Life - Cognition
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The cognition subscale has 2 items with 5-point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for cognition are favorable.
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Week 9
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Health-Related Quality of Life - Pain Intensity
Periodo de tiempo: Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The pain intensity subscale has 1 item with responses ranging from "No Pain" (scored as 0) to "Worst Pain Imaginable" (scored as 10).
Higher scores for pain intensity are not favorable.
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Week 9
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Physical activity
Periodo de tiempo: Week 9
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A modified Godin Leisure-Time Exercise Questionnaire will be used to assess participants' physical activity patterns.
This self-report measure assesses the number of minutes of strenuous-, moderate-, and light-intensity exercise in a typical week (continuous).
Higher scores are favorable, reflecting more aerobic physical activity.
An additional item will be included that assesses the number of bouts of muscle-strengthening exercise in a typical week (0-7).
Higher scores are favorable, reflecting more muscle strengthening physical activity.
We will also gather data provided by consumer-grade, wearable physical activity trackers (Fitbit Charge series or similar).
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Week 9
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michael C. Robertson, PhD, MPH, University of Oklahoma Health Campus
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)
10 de septiembre de 2025
Finalización primaria (Actual)
15 de junio de 2026
Finalización del estudio (Actual)
15 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
14 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 18010
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
IPD will not be made publicly available due to the small sample size and the potential risk of participant re-identification.
Data sharing restrictions are intended to protect participant privacy and confidentiality.
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. .