Exercise as Medicine for People With Cancer Sweden

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer

Conditions
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Prostate Cancer, Breast Cancer, Colorectal Cancer

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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 | Behavioral: Exercise<br>* 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<br>|
| No Intervention: Control<br>The control group will receive routine clinical care according to (inter-) national guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Cancer, Fitness, Distance-based, Home-based