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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
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
Karolinska Institute/ Karolinska University Hospital
Stockholm, Sweden
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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Time frame: Baseline
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Time frame: 3 months
Cardiorespiratory fitness
Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test
Time frame: 6 months
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Time frame: Baseline
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Time frame: 3 months
Physical function of the lower body
Assessed by the 5 sit to stand test (seconds)
Time frame: 6 months
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Time frame: Baseline
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Time frame: 3 months
Upper body muscle strength
Assessed by a hypothetical 12-RM chest press test
Time frame: 6 months
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Time frame: Baseline
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Time frame: 3 months
Lower body muscle strength
Assessed by a hypothetical 12-RM leg press test
Time frame: 6 months
Whole body muscle mass
Assessed by bio impendence device (InBody770) (kg)
Time frame: Baseline
Whole body muscle mass
Assessed by bio impendence device (InBody770) (kg)
Time frame: 3 months
Whole body fat mass
Assessed by bio impendence device (InBody770) (kg)
Time frame: 6 months
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Time frame: Baseline
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Time frame: 3 months
Whole body fat percentage
Assessed by bio impendence device (InBody770) (%)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 6 months
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