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Completed

NCT Number: NCT04772690

Balance, Activity and Quality of Life

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nyborg, 5800, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 6 week

    Scores between 0-100, with higher scores indicating better outcome

Secondary 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

    Time frame: 5 day

    Scores between 0-100, with higher scores indicating better outcome

  2. Change in balance in everyday life using the Occupational Balance Questionnaire 11

    Time frame: 5 day

    Scores between 11-44, with higher scores indicating better outcome

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

    Time frame: 5 day

    Scores between 0-100, with higher scores indicating better outcome

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

    Time frame: 5 day

    Scores between 0-100, with higher scores indicating worse outcome

  5. Change in balance in everyday life using the Occupational Balance Questionnaire 11

    Time frame: 6 week

    Scores between 11-44, with higher scores indicating better outcome

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

    Time frame: 6 week

    Scores between 0-100, with higher scores indicating better outcome

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

    Time frame: 6 week

    Scores between 0-100, with higher scores indicating worse outcome

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

    Time frame: 12 week

    Scores between 0-100, with higher scores indicating better outcome

  9. Change in balance in everyday life using the Occupational Balance Questionnaire 11

    Time frame: 12 week

    Scores between 11-44, with higher scores indicating better outcome

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

    Time frame: 12 week

    Scores between 0-100, with higher scores indicating better outcome

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

    Time frame: 12 week

    Scores between 0-100, with higher scores indicating worse outcome

Sponsors and collaborators

Lead sponsor

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

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

Acronym: BAL

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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