Balance, Activity and Quality of Life

Study Overview
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Brief Summary
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Background: Advanced cancer may cause functional limitations, subsequently leading to decreased ability to perform and engage in everyday activities, such as self-care, household, leisure and civic life. In addition, people with advanced cancer need alleviation from the pain and sorrow following limited life expectancy wherefore they prefer to focus on everyday life function and activities, lightness and enjoyment. The overall aim of the Balance, Activity and quality of Life (BAL) project is to develop, test and evaluate effectiveness and process of a resource-oriented intervention which coordinates rehabilitation and palliative care to enhance quality of life (QoL), balance and enjoyment in everyday activities and functioning. The development of the intervention is guided by the British Medical Research Council's guidance (MRC). The present study consists of a resource-oriented intervention, which will be feasibility tested in the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care. The study will inform the development of a resource-oriented program for people with advanced cancer. Material and Methods: A feasibility study designed as a one-armed, pre-post study with follow-up after five days and again after 6 and 12 weeks. The study will recruit 20-25 home-living adults (⩾18 years) with chronic or advanced cancer reporting needs in everyday life. Outcomes are quality of life, physical function and fatigue assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C-30). Furthermore, balance in everyday activities will be assessed using the Occupational Balance Questionnaire 11 (OBQ-11). Besides outcomes, process data will also be collected regarding: 1) fidelity, 2) adherence, 3) dose and 4) reach and mechanisms of impact with attention to participant's experiences of and interactions with the intervention. These data will be collected using registration forms, questionnaires, participant-observations and focus-group interviews.

Official Title
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Feasibility Study Exploring a Resource-orientered, Coordinated Rehabilitation and Palliative Care Intervention Among People With Advanced Cancer.

Conditions
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Advanced Cancer

Intervention / Treatment
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* Other: A resource-oriented intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Home-living adults Diagnosed with chronic or advanced cancer Report a need of support in everyday life and to better balance everyday life with necessary and meaningful activities Motivated and able to participate in the intervention Know sufficient Danish to complete questionnaires and participate in interviews Exclusion Criteria: Dependent in basic activities of daily living (personal care, dressing and eating) Not able to complete questionnaires and participate in interviews Severe cognitive deficits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAL<br>A resource-orientered, individual and group-based intervention addressing balance in everyday life, activities and QoL among people with chronic or advanced cancer. | Other: A resource-oriented intervention<br>* The intervention is delivered by an interdisciplinary team of occupational therapist, physiotherapist, nurse, psychologist, physician and social worker. It consists of a five-day residential stay at REHPA and a two-day follow-up stay after seven weeks at home. The residential stays include both workshops and engagement in physical and creative activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating better outcome | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating better outcome | 5 day | 
| Change in balance in everyday life using the Occupational Balance Questionnaire 11 | Scores between 11-44, with higher scores indicating better outcome | 5 day | 
| Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating better outcome | 5 day | 
| Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating worse outcome | 5 day | 
| Change in balance in everyday life using the Occupational Balance Questionnaire 11 | Scores between 11-44, with higher scores indicating better outcome | 6 week | 
| Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating better outcome | 6 week | 
| Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating worse outcome | 6 week | 
| Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating better outcome | 12 week | 
| Change in balance in everyday life using the Occupational Balance Questionnaire 11 | Scores between 11-44, with higher scores indicating better outcome | 12 week | 
| Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating better outcome | 12 week | 
| Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 | Scores between 0-100, with higher scores indicating worse outcome | 12 week |