Advanced CancerBALNCT04772690
Balance, Activity and Quality of Life
A study testing A resource-oriented intervention in people with Advanced Cancer, run by REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- A resource-oriented intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 24 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dependent in basic activities of daily living (personal care, dressing and eating)
- Not able to complete questionnaires and participate in interviews
- Severe cognitive deficits
Trial locations and contacts
1 site in 1 country.
Denmark1 site
REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital
Nyborg, 5800
About this study
Official title: 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.
Read more
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
- Being tested
- A resource-oriented intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A resource-oriented interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: A resource-oriented intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Scores between 0-100, with higher scores indicating better outcome
Measured: 5 day
Change in balance in everyday life using the Occupational Balance Questionnaire 11
Scores between 11-44, with higher scores indicating better outcome
Measured: 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
Measured: 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
Measured: 5 day
Change in balance in everyday life using the Occupational Balance Questionnaire 11
Scores between 11-44, with higher scores indicating better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 12 week
Change in balance in everyday life using the Occupational Balance Questionnaire 11
Scores between 11-44, with higher scores indicating better outcome
Measured: 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
Measured: 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
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 May 2021
- Primary completion24 Dec 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Marc Sampedro Pilegaard, PhD, Principal investigator, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative CareKaren la Cour, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772690
- Sponsor's protocol ID
- REHPA
- Acronym
- BAL
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39917823Pilegaard 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.
PubMed 35443699
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Exploring a Resource-orientered, Coordinated Rehabilitation and Palliative Care Intervention Among People With Advanced Cancer.
- ClinicalTrials.gov ID
- NCT04772690
- Acronym / sponsor ID
- BAL / REHPA
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative CareUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 1 May 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAL | Experimental | Other: A resource-oriented interventionA resource-orientered, individual and group-based intervention addressing balance in everyday life, activities and QoL among people with chronic or advanced cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Dependent in basic activities of daily living (personal care, dressing and eating)
- Not able to complete questionnaires and participate in interviews
- Severe cognitive deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A resource-oriented interventionThe 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. | Other | BAL |
Primary outcome
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
11 secondary outcomes
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
Change in balance in everyday life using the Occupational Balance Questionnaire 11
Time frame: 5 day
Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
Time frame: 5 day
Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
Time frame: 5 day
Change in balance in everyday life using the Occupational Balance Questionnaire 11
Time frame: 6 week
Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
Time frame: 6 week
Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
Time frame: 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
Time frame: 12 week
Change in balance in everyday life using the Occupational Balance Questionnaire 11
Time frame: 12 week
Change in physical function using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
Time frame: 12 week
Change in fatigue using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 39917823Brunsgaard 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.
- Derived from this study: PubMed 35443699Pilegaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Sampedro Pilegaard, PhD principal investigator
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
Karen la Cour, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A resource-oriented intervention in people with Advanced Cancer, run by REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.