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NCT Number: NCT07557043

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Do not speak or understand Danish

Treatment and study plan

BALanSE intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The Brief Health Literacy Scale For Adults (B-HLA)

    Time frame: Measured at baseline

    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.

  2. The Three-Item Loneliness Scale (T-ILS)

    Time frame: Measured at baseline and 7 and 18 weeks after baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Tvede Madsen, PhD

CONTACT

[email protected]

+4528551373

Karen la Cour, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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

Acronym: BALanSE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

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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