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Balance, Activity and Quality of Life

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04772690
Acronym
BAL
Enrollment
22
Registered
2021-02-26
Start date
2021-05-01
Completion date
2021-12-24
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Brief 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.

Interventions

OTHERA 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 306 weekScores between 0-100, with higher scores indicating better outcome

Secondary

MeasureTime frameDescription
Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 305 dayScores between 0-100, with higher scores indicating better outcome
Change in balance in everyday life using the Occupational Balance Questionnaire 115 dayScores between 11-44, with higher scores indicating better outcome
Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 305 dayScores between 0-100, with higher scores indicating better outcome
Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 305 dayScores between 0-100, with higher scores indicating worse outcome

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026