Clinical trial NCT04772690: Balance, Activity and Quality of Life
Official title: Feasibility Study Exploring a Resource-orientered, Coordinated Rehabilitation and Palliative Care Intervention Among People With Advanced Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2021-02-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 6 week
Secondary outcomes:
measure: Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 5 day
measure: Change in balance in everyday life using the Occupational Balance Questionnaire 11
timeFrame: 5 day
measure: Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 5 day
measure: Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 5 day
measure: Change in balance in everyday life using the Occupational Balance Questionnaire 11
timeFrame: 6 week
measure: Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 6 week
measure: Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 6 week
measure: Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 12 week
measure: Change in balance in everyday life using the Occupational Balance Questionnaire 11
timeFrame: 12 week
measure: Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 12 week
measure: Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
timeFrame: 12 week
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital
Study officials:
affiliation: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
name: Marc Sampedro Pilegaard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Karen la Cour, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pilegaard MS, Timm H, Birkemose HK, Dupont SB, Joergensen DS, la Cour K. A resource-oriented intervention addressing balance in everyday activities and quality of life in people with advanced cancer: protocol for a feasibility study. Pilot Feasibility Stud. 2022 Apr 20;8(1):86. doi: 10.1186/s40814-022-01038-8.