Balance, Activity and Quality of Life

NCT04772690 | Completed

• 1 other identifier: REHPA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in global health status/ quality of life using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30

  5 day

• Change in balance in everyday life using the Occupational Balance Questionnaire 11

  5 day

• Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30

  5 day

• Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30

  5 day

• Change in balance in everyday life using the Occupational Balance Questionnaire 11

  6 week

Study Arms (1)

BAL

EXPERIMENTAL

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

Interventions

A resource-oriented intervention OTHER

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.

BAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dependent in basic activities of daily living (personal care, dressing and eating)
• Not able to complete questionnaires and participate in interviews
• Severe cognitive deficits

Sponsors & Collaborators

• REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care: lead
• University of Southern Denmark: collaborator

Study Sites (1)

REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital

Nyborg, 5800, Denmark

Location

Related Publications (2)

• Brunsgaard Laursen M, Sampedro Pilegaard M, la Cour K. Promising results of a resource- and activity-oriented intervention integrating rehabilitation into palliative care in people with advanced cancer: A feasibility study testing outcome measures. Palliat Support Care. 2025 Feb 7;23:e55. doi: 10.1017/S1478951524001652.

  PMID: 39917823 DERIVED

• 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.

  PMID: 35443699 DERIVED

Study Officials

• Marc Sampedro Pilegaard, PhD

  REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

  PRINCIPAL INVESTIGATOR

• Karen la Cour, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: May 1, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

DK (1)