Balance, Activity and Quality of Life

Advanced Cancer Clinical Trial

— BAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772690
• Other study ID #: REHPA
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 24, 2021

Study information

• Verified date: March 2023
• Source: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Other:
• A resource-oriented intervention
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.

Locations

Country	Name	City	State
Denmark	REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital	Nyborg

Sponsors (2)

Lead Sponsor	Collaborator
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in balance in everyday life using the Occupational Balance Questionnaire 11	Scores between 11-44, with higher scores indicating better outcome	5 day
Secondary	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
Secondary	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
Secondary	Change in balance in everyday life using the Occupational Balance Questionnaire 11	Scores between 11-44, with higher scores indicating better outcome	6 week
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in balance in everyday life using the Occupational Balance Questionnaire 11	Scores between 11-44, with higher scores indicating better outcome	12 week
Secondary	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
Secondary	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