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临床试验/NCT05333016
NCT05333016已完成不适用

A Dyadic Approach to Cancer Care: a Feasibility and Efficacy Partner-based Exercise Study

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Recruitment

研究概览

简要总结

The primary goal of this study will be to assess the feasibility and acceptability of a partner-based 12-week exercise intervention for cancer caregivers and their care recipient. The researchers will also explore the preliminary effectiveness of the exercise program on caregiver burden and physical and psychological health of both the family caregiver and the care recipient.

详细描述

NEED: Cancer has been characterized as a family affair, as it is a disease in which both the patient and their family members are confronted by considerable physical and psychological stressors. With an anticipated 80% increase in the average number of new cancer diagnoses by 2030 and rapidly escalating health care costs, there has been a shift to outpatient and home-based care. In doing so, family members are increasingly being called upon to participate as informal caregivers (i.e., an individual who provided uncompensated care). Despite being a key partner in the supportive care of the cancer patient, family caregivers are often inadequately prepared or supported to take on this critical role, subsequently putting their own health and well-being at risk and by extension, that of the cancer patient/survivor. Preliminary data suggests that exercise interventions show promise in mitigating caregiver burden and improving health outcomes for both the caregiver and the patient/survivor. To date, however only two studies have examined the benefit of exercise interventions on family caregiver and patient outcomes within the cancer care context.

GOAL: The primary goal of this study will be to assess the feasibility and acceptability of a partner-based 12-week exercise intervention. The investigators will also explore the preliminary effectiveness of the exercise program on caregiver burden and physical and psychological health of both the family caregiver and the care recipient.

WHO: Participants will include adult primary caregivers and cancer patients/survivors of all cancers and stages at any point along the cancer care trajectory.

HOW: Using both surveys and participant interviews, the participant experience and impact (e.g., physical and psychological health benefits) of a 12-week, partner-based exercise intervention will be evaluated. The 12-week exercise program will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a partner-based setting twice weekly at a dedicated cancer and exercise lab.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Multimodal Exercise Intervention

Experimental

12-week, twice weekly partner-based multimodal exercise program

干预措施: Multimodal exercise (Behavioral)

结局指标

主要结局

Recruitment

时间窗: Through study completion, about 2 years

Participant accrual as defined as the number of eligible participant dyads who consents to participate

Adverse Events

时间窗: Through study completion, about 2 years

Adverse and serious adverse events will be recorded

Intervention Adherence

时间窗: Through study completion, about 2 years

Participant program adherence calculated as percentage of exercise sessions completed divided by total number of available exercise sessions over 12-week intervention

Attrition

时间窗: Through study completion, about 2 years

Participant attrition calculated as percentage of patients who complete 12-week study divided by number who withdraw from study

Participant Satisfaction

时间窗: Post intervention, about 12-weeks after baseline

Participant satisfaction will be assessed by semi-structured interviews (no min/max)

次要结局

  • Caregiver Burden(Pre to post intervention (12-week change))
  • Body Composition(Pre to post intervention (12-week change))
  • Resting Blood Pressure(Pre to post intervention (12-week change))
  • Upper Body Strength(Pre to post intervention (12-week change))
  • General Health (EuroQol) 5 Dimension - 5 Level(Pre to post intervention (12-week change))
  • Resting heart rate(Pre to post intervention (12-week change))
  • Body Mass Index (BMI)(Pre to post intervention (12-week change))
  • Aerobic Fitness(Pre to post intervention (12-week change))
  • Muscular Endurance(Pre to post intervention (12-week change))
  • Balance(Pre to post intervention (12-week change))
  • Flexibility(Pre to post intervention (12-week change))
  • Caregiver Quality of Life(Pre to post intervention (12-week change))
  • Cancer Patient Quality of Life(Pre to post intervention (12-week change))
  • Cancer Patient Fatigue(Pre to post intervention (12-week change))
  • Self-Reported Physical Activity(Pre to post intervention (12-week change))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Keats

Affiliated Scientist

Nova Scotia Health Authority

研究点 (2)

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