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| Name | Class |
|---|---|
| Swedish Cancer Society | OTHER |
| SATS | UNKNOWN |
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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.
The primary aim of the study is to examine the effectiveness of EX-MED Cancer Sweden on health-related quality of life in people diagnosed with breast, prostate, and colorectal cancer.
The secondary aims are to examine the effect of the program on other important endpoints such as physical activity level, physical function, muscle strength, exercise capacity, symptoms, and body composition (lean and fat mass).
To determine the sustainability of the effects of the supervised program, the study includes a 3-month follow-up time point (6 months post-baseline)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | The 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 |
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| Control | No Intervention | The control group will receive routine clinical care according to (inter-) national guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer related fatigue | Assessed by the Piper Fatigue scale (PFS) (total cancer related fatigue scale). Participants respond to questions about their fatigue on a scale of 1 (being positive)-10 (being bad/negative) | Baseline |
| Cancer related fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Wengström, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institute/ Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40467967 | Derived | 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. | |
| 36800978 | Derived | Kotte 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. |
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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.
The data will become available within 5 years of study completion and will be available for visibility and accessibility for 10 years.
Researchers will have to apply through SND using DORIS to access the data. Once approved, the data is released.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
Assessed by the Piper Fatigue scale (PFS) (total cancer related fatigue scale). Participants respond to questions about their fatigue on a scale of 1 (being positive)-10 (being bad/negative)
| 3 months |
| Cancer related fatigue | Assessed by the Piper Fatigue scale (PFS) (total cancer related fatigue scale). Participants respond to questions about their fatigue on a scale of 1 (being positive)-10 (being bad/negative) | 6 months |
| Symptoms and symptom burden (total symptoms scale) | Assessed by the memorial symptom assessment scale (MSAS) (total symptoms scale). Patients respond to how often the have had the symptoms (1-almost never- 4 almost always), how severe the symptoms have been (1- light - 4- very severe) and how distressing the symptoms were to them (0- not at all- to 4 very) | Baseline |
| Symptoms and symptom burden (total symptoms scale) | Assessed by the memorial symptom assessment scale (MSAS) (total symptoms scale). Patients respond to how often the have had the symptoms (1-almost never- 4 almost always), how severe the symptoms have been (1- light - 4- very severe) and how distressing the symptoms were to them (0- not at all- to 4 very) | 3 months |
| Symptoms and symptom burden (total symptoms scale) | Assessed by the memorial symptom assessment scale (MSAS) (total symptoms scale). Patients respond to how often the have had the symptoms (1-almost never- 4 almost always), how severe the symptoms have been (1- light - 4- very severe) and how distressing the symptoms were to them (0- not at all- to 4 very) | 6 months |
| Cardiorespiratory fitness | Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test | Baseline |
| Cardiorespiratory fitness | Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test | 3 months |
| Cardiorespiratory fitness | Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test | 6 months |
| Physical function of the lower body | Assessed by the 5 sit to stand test (seconds) | Baseline |
| Physical function of the lower body | Assessed by the 5 sit to stand test (seconds) | 3 months |
| Physical function of the lower body | Assessed by the 5 sit to stand test (seconds) | 6 months |
| Upper body muscle strength | Assessed by a hypothetical 12-RM chest press test | Baseline |
| Upper body muscle strength | Assessed by a hypothetical 12-RM chest press test | 3 months |
| Upper body muscle strength | Assessed by a hypothetical 12-RM chest press test | 6 months |
| Lower body muscle strength | Assessed by a hypothetical 12-RM leg press test | Baseline |
| Lower body muscle strength | Assessed by a hypothetical 12-RM leg press test | 3 months |
| Lower body muscle strength | Assessed by a hypothetical 12-RM leg press test | 6 months |
| Whole body muscle mass | Assessed by bio impendence device (InBody770) (kg) | Baseline |
| Whole body muscle mass | Assessed by bio impendence device (InBody770) (kg) | 3 months |
| Whole body fat mass | Assessed by bio impendence device (InBody770) (kg) | 6 months |
| Whole body fat percentage | Assessed by bio impendence device (InBody770) (%) | Baseline |
| Whole body fat percentage | Assessed by bio impendence device (InBody770) (%) | 3 months |
| Whole body fat percentage | Assessed by bio impendence device (InBody770) (%) | 6 months |
| Self reported physical activity | Assessed by the Godin Leisure time physical activity questionnaire (mins). Patients detail how many minutes per week they have performed vigorous, moderate and low intensity physical activity | Baseline |
| Self reported physical activity | Assessed by the Godin Leisure time physical activity questionnaire (mins). Patients detail how many minutes per week they have performed vigorous, moderate and low intensity physical activity | 3 months |
| Self reported physical activity | Assessed by the Godin Leisure time physical activity questionnaire (mins). Patients detail how many minutes per week they have performed vigorous, moderate and low intensity physical activity | 6 months |
| Self efficacy of exercise | Assessed by the Self-Efficacy of Exercise (SEE) questionnaire (total score). Patients respond to questions ranging from 0 (not at all sure) to 10 (completely sure) | Baseline |
| Self efficacy of exercise | Assessed by the Self-Efficacy of Exercise (SEE) questionnaire (total score). Patients respond to questions ranging from 0 (not at all sure) to 10 (completely sure) | 3 months |
| Self efficacy of exercise | Assessed by the Self-Efficacy of Exercise (SEE) questionnaire (total score). Patients respond to questions ranging from 0 (not at all sure) to 10 (completely sure) | 6 months |
| Quality adjusted life years | Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine) | Baseline |
| Quality adjusted life years | Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine) | 3 months |
| Quality adjusted life years | Assessed by the EQ-5D-5L questionnaire . Patients rate their health from 0 (worst health you can imagine)-100 (best health you can imagine) | 6 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). | 6 months |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |