CancerBALanSENCT07557043
Testing the Feasibility of Balance, Activity, Quality of Life and Social Equity (BALanSE): An Activity- and Resource-oriented Rehabilitation and Palliative Care Intervention for People With Cancer
A study testing BALanSE intervention in people with Cancer, run by University of Southern Denmark.
Trial summary
Research shows that people living with cancer often struggle to manage their energy and resources in a way that allows them to take part in the everyday activities that matter most to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- BALanSE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult (≥ 18 years) and residing in their own home.
- Diagnosed with cancer.
- Referred to a §119 in the Danish Health Act, which concerns preventive and health-promoting services.
- Experiences a need for support to manage everyday occupations.
- Is able to participate in the BALanSE intervention and willing to complete questionnaires and participate in interviews.
- Must be independent concerning personal occupations of daily living (personal care, dressing and eating)
- Residence in Odense municipality, Denmark
- Speaks and understands the Danish language
Who cannot join
- Do not speak or understand Danish
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Karen la Cour, Professor contact
About this study
Official title: Testing the Feasibility of Balance, Activity, Quality of Life and Social Equity (BALanSE): An Activity- and Resource-oriented Rehabilitation and Palliative Care Intervention for People With Cancer - Protocol for a Feasibility Study
Research shows that people living with cancer often struggle to manage their energy and resources in a way that allows them to take part in the everyday activities that matter most to them. Studies also show that activities that bring joy, involve physical movement, and offer social connection are especially important for coping with advanced cancer. These kinds of activities can help shift focus away from illness and problems, and instead bring meaning to the time that remains.
Because of this, people with cancer need support that both helps them function as well as possible and gives them opportunities to experience relief and well-being.
Read more
The project "Balance, Activity and Quality of Life" (BALanSE) focuses on developing and testing a community-based program that supports people in finding balance in their daily activities, experiencing joy, and improving their quality of life. The program is mainly group-based and includes workshops with presentations and hands-on activities.
A first version of the program was tested at the research clinic at REHPA - the Danish Knowledge Centre for Rehabilitation and Palliative Care - and showed that participants experienced improved health-related quality of life. This positive outcome forms the basis for further developing the program into a municipal service, so more people can benefit from it.
The next phase of development and testing is being done in collaboration with the Center for Cancer Rehabilitation and Palliative Care in Odense Municipality. The project also includes research-based strategies to reduce social inequality in health.
The project is anchored at the Research Unit for User Perspectives and Citizen-Centered Interventions at the University of Southern Denmark.
The overall goal of the project is to further develop and test the program as a municipal service for people with cancer, supporting them in managing daily life and participating in meaningful activities that bring joy and balance-ultimately helping them experience the best possible quality of life.
- Conditions
- Cancer
- Being tested
- BALanSE intervention
- Keywords
- Cancer and every day llife
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALanSE interventionBehavioural
The BALanSE intervention combines group sessions, individual consultations, and home visits delivered by occupational therapists, physiotherapists, dieticians, nurses and psychologists. Each participant is assigned a coordinating healthcare professional, who remains their primary point of contact. Each participant receives an initial consultation, where a HP and the participant discuss current needs and set goals by Goal Attainment Scale - Light (GAS-L).
A final consultation evaluates the needs and three weeks after the final consultation the participant receives a follow-up phone call. Additionally, one home visit is included to support that the participant integrates newly acquired knowledge from the intervention into their everyday life.
The BALanSE intervention includes four themes each covered across 11 group sessions.
- Activity, balance, and everyday life.
- Life in change.
- Movement and nature.
- Creativity, diet and immersion.
| Study group | Role | What they receive |
|---|---|---|
| BALanSE intervention | Experimental | The BALanSE intervention combines group sessions, individual consultations, and home visits delivered by occupational therapists, physiotherapists, dieticians, nurses and psychologists. The participants attend one or two group sessions per week over a seven-week period, covering different themes. The sessions provide opportunities for peer support, reflection, discussion and engagement in various activities.
Individual consultations Receives: Behavioral: BALanSE intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C-30)
EORTC QLQ-C-30 is a cancer-specific questionnaire that measures quality of life, physical function and fatigue, containing 30 questions. Answers are scored on an ordinal scale ranging from 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much). Additionally, the questionnaire measures quality of life using an ordinal scale ranging from 1 to 7. The ordinal data are transformed into a score ranging from 0 to 100, where a higher score equals better function and higher quality of life or poorer experienced symptoms. EORTC QLQ-C-30 has good reliability and validity.
Measured: Measures at baseline and 7,10 and 18 weeks after baseline.
Secondary outcomes (2)
The Brief Health Literacy Scale For Adults (B-HLA)
Health literacy is measured by The Brief Health Literacy Scale For Adults (B-HLA). The B-HLA is an adapted version of the Health Literacy for School-Aged Children Questionnaire and has recently been validated in a Danish context. The B-HLA is a 10-item instrument for measuring health literacy across five components: theoretical knowledge, practical knowledge, critical thinking, self-awareness, and citizenship (with two items allocated to each component). Respondents express their responses on a 4-point scale using the following categories: 1 point=Not at all true, 2 points=Not completely true, 3 points=Somewhat true, and 4 points=Absolutely true. The score is calculated, and cut-off values regarding respondent's health literacy: low health literacy (10-25 points), moderate health literacy (26-35 points), and high health literacy (36-40 points). The B-HLA has good validity and reliability.
Measured: Measured at baseline
The Three-Item Loneliness Scale (T-ILS)
Loneliness is measured by The Three-Item Loneliness Scale (T-ILS). The T-ILS is a validated shortened version of one of the most widely used loneliness measurement tools, the UCLA Loneliness Scale (UCLA-LS). The UCLA-LS has been translated and validated into the Danish context in 2006. The T-ILS consists of three questions and answers are scored on a scale ranged from 1 to 3 on a likert scale (1 = never, 2 = sometimes, and 3 = always). T-ILS has good reliability and validity.
Measured: Measured at baseline and 7 and 18 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study including one arm (intervention).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557043
- Sponsor's protocol ID
- 12.624
- Acronym
- BALanSE
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through research papers, conferences etc.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of Balance, Activity, Quality of Life and Social Equity (BALanSE): An Activity- and Resource-oriented Rehabilitation and Palliative Care Intervention for People With Cancer - Protocol for a Feasibility Study
- ClinicalTrials.gov ID
- NCT07557043
- Acronym / sponsor ID
- BALanSE / 12.624
- Conditions
- Cancer
- Keywords
- Cancer and every day llife
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Apr 2026 (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.
Research shows that people living with cancer often struggle to manage their energy and resources in a way that allows them to take part in the everyday activities that matter most to them. Studies also show that activities that bring joy, involve physical movement, and offer social connection are especially important for coping with advanced cancer. These kinds of activities can help shift focus away from illness and problems, and instead bring meaning to the time that remains.
Because of this, people with cancer need support that both helps them function as well as possible and gives them opportunities to experience relief and well-being.
The project "Balance, Activity and Quality of Life" (BALanSE) focuses on developing and testing a community-based program that supports people in finding balance in their daily activities, experiencing joy, and improving their quality of life. The program is mainly group-based and includes workshops with presentations and hands-on activities.
A first version of the program was tested at the research clinic at REHPA - the Danish Knowledge Centre for Rehabilitation and Palliative Care - and showed that participants experienced improved health-related quality of life. This positive outcome forms the basis for further developing the program into a municipal service, so more people can benefit from it.
The next phase of development and testing is being done in collaboration with the Center for Cancer Rehabilitation and Palliative Care in Odense Municipality. The project also includes research-based strategies to reduce social inequality in health.
The project is anchored at the Research Unit for User Perspectives and Citizen-Centered Interventions at the University of Southern Denmark.
The overall goal of the project is to further develop and test the program as a municipal service for people with cancer, supporting them in managing daily life and participating in meaningful activities that bring joy and balance-ultimately helping them experience the best possible quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study including one arm (intervention).
| Arm | Type | Receives |
|---|---|---|
| BALanSE intervention | Experimental | Behavioral: BALanSE interventionThe BALanSE intervention combines group sessions, individual consultations, and home visits delivered by occupational therapists, physiotherapists, dieticians, nurses and psychologists. The participants attend one or two group sessions per week over a seven-week period, covering different themes. The sessions provide opportunities for peer support, reflection, discussion and engagement in various activities. Individual consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (≥ 18 years) and residing in their own home.
- Diagnosed with cancer.
- Referred to a §119 in the Danish Health Act, which concerns preventive and health-promoting services.
- Experiences a need for support to manage everyday occupations.
- Is able to participate in the BALanSE intervention and willing to complete questionnaires and participate in interviews.
Key exclusion criteria (1 listed)
- Do not speak or understand Danish
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 |
|---|---|---|
| BALanSE interventionThe BALanSE intervention combines group sessions, individual consultations, and home visits delivered by occupational therapists, physiotherapists, dieticians, nurses and psychologists. Each participant is assigned a coordinating healthcare professional, who remains their primary point of contact. Each participant receives an initial consultation, where a HP and the participant discuss current needs and set goals by Goal Attainment Scale - Light (GAS-L). A final consultation evaluates the needs and three weeks after the final consultation the participant receives a follow-up phone call. Additionally, one home visit is included to support that the participant integrates newly acquired knowledge from the intervention into their everyday life. The BALanSE intervention includes four themes each covered across 11 group sessions. 1. Activity, balance, and everyday life. 2. Life in change. 3. Movement and nature. 4. Creativity, diet and immersion. | Behavioural | BALanSE intervention |
Primary outcome
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C-30)
Time frame: Measures at baseline and 7,10 and 18 weeks after baseline.
EORTC QLQ-C-30 is a cancer-specific questionnaire that measures quality of life, physical function and fatigue, containing 30 questions. Answers are scored on an ordinal scale ranging from 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much). Additionally, the questionnaire measures quality of life using an ordinal scale ranging from 1 to 7. The ordinal data are transformed into a score ranging from 0 to 100, where a higher score equals better function and higher quality of life or poorer experienced symptoms. EORTC QLQ-C-30 has good reliability and validity.
2 secondary outcomes
The Brief Health Literacy Scale For Adults (B-HLA)
Time frame: Measured at baseline
The Three-Item Loneliness Scale (T-ILS)
Time frame: Measured at baseline and 7 and 18 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Through research papers, conferences etc.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Karen la Cour, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing BALanSE intervention in people with Cancer, run by University of Southern 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 8 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Tvede Madsen, PhD (+4528551373, cmtmadsen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C-30) (time frame: Measures at baseline and 7,10 and 18 weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.