Balance, Activity and Quality of Life (BAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: A resource-oriented intervention

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nyborg, Denmark, 5800
    • REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAL; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Karen la Cour, PhD, University of Southern Denmark; Principal Investigator: Marc Sampedro Pilegaard, PhD, REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 24, 2021
• Study Completion (Actual): December 24, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: REHPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No