Testing the Feasibility of Balance, Activity, Quality of Life and Social Equity (BALanSE): An Activity- and Resource-oriented Rehabilitation and Palliative Care Intervention for People With Cancer

Официальное название

Testing the Feasibility of Balance, Activity, Quality of Life and Social Equity (BALanSE): An Activity- and Resource-oriented Rehabilitation and Palliative Care Intervention for People With Cancer - Protocol for a Feasibility Study

Обзор

Research shows that people living with cancer often struggle to manage their energy and resources in a way that allows them to take part in the everyday activities that matter most to them. Studies also show that activities that bring joy, involve physical movement, and offer social connection are especially important for coping with advanced cancer. These kinds of activities can help shift focus away from illness and problems, and instead bring meaning to the time that remains. Because of this, people with cancer need support that both helps them function as well as possible and gives them opportunities to experience relief and well-being. The project "Balance, Activity and Quality of Life" (BALanSE) focuses on developing and testing a community-based program that supports people in finding balance in their daily activities, experiencing joy, and improving their quality of life. The program is mainly group-based and includes workshops with presentations and hands-on activities. A first version of the program was tested at the research clinic at REHPA - the Danish Knowledge Centre for Rehabilitation and Palliative Care - and showed that participants experienced improved health-related quality of life. This positive outcome forms the basis for further developing the program into a municipal service, so more people can benefit from it. The next phase of development and testing is being done in collaboration with the Center for Cancer Rehabilitation and Palliative Care in Odense Municipality. The project also includes research-based strategies to reduce social inequality in health. The project is anchored at the Research Unit for User Perspectives and Citizen-Centered Interventions at the University of Southern Denmark. The overall goal of the project is to further develop and test the program as a municipal service for people with cancer, supporting them in managing daily life and participating in meaningful activities that bring joy and balance-ultimately helping them experience the best possible quality of life.

Вмешательства

• Поведенческое BALanSE intervention
  The BALanSE intervention combines group sessions, individual consultations, and home visits delivered by occupational therapists, physiotherapists, dieticians, nurses and psychologists. Each participant is assigned a coordinating healthcare professional, who remains their primary point of contact. Each participant receives an initial consultation, where a HP and the participant discuss current needs and set goals by Goal Attainment Scale - Light (GAS-L). A final consultation evaluates the needs

Первичные конечные точки

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C-30) [Срок оценки: Measures at baseline and 7,10 and 18 weeks after baseline.]

Вторичные конечные точки (2)

• The Brief Health Literacy Scale For Adults (B-HLA) [Срок оценки: Measured at baseline]
• The Three-Item Loneliness Scale (T-ILS) [Срок оценки: Measured at baseline and 7 and 18 weeks after baseline]

Критерии участия

Критерии включения

• Adult (≥ 18 years) and residing in their own home.
• Diagnosed with cancer.
• Referred to a §119 in the Danish Health Act, which concerns preventive and health-promoting services.
• Experiences a need for support to manage everyday occupations.
• Is able to participate in the BALanSE intervention and willing to complete questionnaires and participate in interviews.
• Must be independent concerning personal occupations of daily living (personal care, dressing and eating)
• Residence in Odense municipality, Denmark
• Speaks and understands the Danish language

Критерии исключения

• Do not speak or understand Danish

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07557043 · 12.624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗