Exercise as Medicine for People With Cancer Sweden
EX-MED
EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer
1 other identifier
interventional
200
1 country
1
Brief Summary
Regular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people while providing the support of an exercise professional. The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes. Participants will be randomized to a 3-month supervised, distance-based exercise program or to a usual care control group. Testing timepoints are baseline, 3 months (end of intervention) and 6 months (3 month followup). At these timepoints, patients will be asked to fill in online questionaires, and and undergo physical tests. A selection of the particpants and personal trainers involved in the intervention will also be invited to participate in focus group discussion or interviews about the experiences of being involved in the EX-MED Cancer Sweden program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedStudy Start
First participant enrolled
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2024
CompletedNovember 18, 2024
November 1, 2024
2.8 years
September 22, 2021
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Health-related quality of life
Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).
Baseline, 3 months
Health-related quality of life
Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).
3 months
Secondary Outcomes (34)
Cancer related fatigue
Baseline
Cancer related fatigue
3 months
Cancer related fatigue
6 months
Symptoms and symptom burden (total symptoms scale)
Baseline
Symptoms and symptom burden (total symptoms scale)
3 months
- +29 more secondary outcomes
Study Arms (2)
Exercise
EXPERIMENTALThe intervention group will, in addition to routine clinical care according to (inter-) national guidelines, receive an exercise program of resistance and aerobic exercise delivered live online by an upskilled exercise professional in group exercise classes twice weekly for 3 months
Control
NO INTERVENTIONThe control group will receive routine clinical care according to (inter-) national guidelines
Interventions
A twice weekly, 3-month supervised exercise program of whole body resistance training using body weight and a resistance band, and moderate to high intensity aerobic activities, consisting of a consecutive series of timed exercises performed one after the other (14-18 on the Borg scale). Classes are conducted live in groups through Microsoft Teams. Participants will not receive any contact or exercise support in the 3-month follow-up period following the initial 3-month intervention
Eligibility Criteria
You may qualify if:
- years or older
- males or females
- people diagnosed with any type of stage I-IIIa breast, prostate or colorectal cancer who have undergone and completed curative treatment (note: participants are eligible if they are currently receiving/scheduled to receive anti-hormonal therapy) at the Karolinska Comprehensive Cancer Centre, Sweden
You may not qualify if:
- currently receiving or scheduled to receive cancer treatment (except anti-hormonal therapy)
- any medical conditions that may prevent safe participation in the testing or exercise demands of the study
- performing regular exercise throughout the last month defined as undertaking at least 150 mins moderate intensity aerobic exercise and two or more structured resistance exercise sessions per week
- unable to read and speak Swedish.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Swedish Cancer Societycollaborator
- SATScollaborator
Study Sites (1)
Karolinska Institute/ Karolinska University Hospital
Stockholm, Sweden
Related Publications (2)
Kotte M, Bolam KA, Altena R, Cormie P, Wengstrom Y, Mijwel S. Effects of live-remote exercise on quality of life and other health-related outcomes in cancer survivors: a randomised controlled trial. J Cancer Surviv. 2025 Jun 5. doi: 10.1007/s11764-025-01845-x. Online ahead of print.
PMID: 40467967DERIVEDKotte M, Bolam KA, Mijwel S, Altena R, Cormie P, Wengstrom Y. Distance-based delivery of exercise for people treated for breast, prostate or colorectal cancer: a study protocol for a randomised controlled trial of EX-MED Cancer Sweden. Trials. 2023 Feb 17;24(1):116. doi: 10.1186/s13063-023-07152-z.
PMID: 36800978DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvonne Wengström, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 1, 2021
Study Start
January 11, 2022
Primary Completion
October 21, 2024
Study Completion
October 21, 2024
Last Updated
November 18, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- The data will become available within 5 years of study completion and will be available for visibility and accessibility for 10 years.
- Access Criteria
- Researchers will have to apply through SND using DORIS to access the data. Once approved, the data is released.
The dataset will be stored via the Swedish National Data Service (SND) and provided a Digital Object Identifier (DOI).SND is a trusted digital repository, certified against CoreTrustSeal. Through their system DORIS, an examination of the metadata quality carried out by the KI Data Access Unit will be conducted of the data. When the data description is complete, it is published in the SND research data catalog.