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

NCT07557043 | Not Yet Recruiting

• 1 other identifier: 12.624
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cancer

Keywords

Cancer and every day llife

Outcome Measures

Primary Outcomes (1)

• 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.

  Measures at baseline and 7,10 and 18 weeks after baseline.

Secondary Outcomes (2)

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

  Measured at baseline

• The Three-Item Loneliness Scale (T-ILS)

  Measured at baseline and 7 and 18 weeks after baseline

Study Arms (1)

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

Behavioral: BALanSE intervention

Interventions

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. 1. Activity, balance, and everyday life. 2. Life in change. 3. Movement and nature. 4. Creativity, diet and immersion.

BALanSE intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do not speak or understand Danish

Sponsors & Collaborators

• University of Southern Denmark: lead

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Christina Tvede Madsen, PhD

CONTACT

+4528551373; cmtmadsen@health.sdu.dk

Karen la Cour, Professor

CONTACT

klacour@sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study including one arm (intervention).

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share