Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers

Официальное название

Dyadic Behavioral Interventions to Manage Physical Performance, Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers

Обзор

This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and/or their caregivers.

Подробное описание

PRIMARY OBJECTIVE:

I. To examine the extent to which the yoga program improves patient physical performance (i.e., 6-minute walk test \[6MWT\]) as compared to the education group.

SECONDARY OBJECTIVE:

I. To examine the extent to which the yoga program improves patient and caregiver quality of life (QOL) (SF-36) compared to the education group.

TERTIARY OBJECTIVES:

I. To explore if, compared to the education group, the yoga program improves symptom burden, reduces inflammatory cytokine and cortisol rhythmicity dysregulation, and improves dyadic symptom management skills at the end of treatment, which will in turn mediate intervention outcomes at the subsequent follow-up assessments.

II. To explore if baseline factors such as depressive symptoms moderate the treatment response. We also seek to explore if baseline factors such as depressive symptoms moderate the treatment response.

QUALITATIVE OBJECTIVE:

I. To understand the patient and caregiver experience of cancer, cancer treatment, and experience in the behavioral interventions, and explore emerging themes as possible mediators. We would also like to understand participants feedback on participating in this intervention via mobile application (app) delivery.

OUTLINE: Patients and caregivers are assigned to 1 of 2 groups.

GROUP I: Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.

GROUP II: Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.

After completion of study, patients and caregivers are followed up every 2 weeks for 3 months and then every month for up to 6 months.

Вмешательства

• Другое Educational Intervention
  Undergo dyadic education program
• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies
• Процедура Yoga
  Undergo dyadic yoga

Первичные конечные точки

• Patient 6-minute walk test (6MWT) [Срок оценки: At 3 months post study]

Вторичные конечные точки (1)

• Patient and caregiver quality of life (QOL) [Срок оценки: Up to 6 months post study]

Критерии участия

Критерии включения

• PATIENT ONLY: Diagnosed with stage I-IV non-small cell lung cancer (NSCLC) or esophageal cancer and going to receive at least 3 weeks of thoracic radiotherapy (RT)
• PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• PATIENT ONLY: Able to read, write and speak English
• PATIENT ONLY: Able to provide informed consent
• PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) who assists the patient during the cancer treatment (e.g., emotional support, transportation, meal preparation, care coordination, etc) per patient self-report. Note, patients must identify a family caregiver; however, the participation of the family caregiver is optional. For caregivers to be eligible, they must be at least 18 years old; able to read, write and speak English; and able to provide informed consent. Family caregivers may consent to participate in the intervention and caregiver assessments or only the assessments based on their preference.

Критерии исключения

• PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis
• PATIENT ONLY: Patients who metastatic disease involving the central nervous system

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• M D Anderson Cancer Center — Houston

Публикации

• Snyder S, Silva RF, Whisenant MS, Milbury K. Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician's Perspective. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019111. doi: 10.1177/15347354211019111. PMID 34036820

Идентификаторы

NCT: NCT03948100 · 2018-0503 · NCI-2018-03913 · 2018-0503 · R37CA231522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗