Balance, Activity and Quality of Life

NCT ID: NCT04772690

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-12-24

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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BAL

A resource-orientered, individual and group-based intervention addressing balance in everyday life, activities and QoL among people with chronic or advanced cancer.

Group Type EXPERIMENTAL

A resource-oriented intervention

Intervention Type 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.

Interventions

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A resource-oriented intervention

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Sampedro Pilegaard, PhD

Role: PRINCIPAL_INVESTIGATOR

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

Karen la Cour, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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

Nyborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 39917823 (View on PubMed)

Pilegaard 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.

Reference Type DERIVED
PMID: 35443699 (View on PubMed)

Other Identifiers

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REHPA

Identifier Type: -

Identifier Source: org_study_id

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