Exercise as Medicine for People With Cancer Sweden

Breast Cancer Clinical Trial

— EX-MED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064670
• Other study ID #: Dnr 2019-04151
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: November 2024

Study information

• Verified date: January 2023
• Source: Karolinska Institutet
• Contact: Yvonne Wengström, PhD
• Phone: +46707528547
• Email: yvonne.wengstrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Prostate Cancer

Intervention

Behavioral:
• Exercise
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

Locations

Country	Name	City	State
Sweden	Karolinska Institute/ Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	SATS, Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cardiorespiratory fitness	Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test	Baseline
Secondary	Cardiorespiratory fitness	Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test	3 months
Secondary	Cardiorespiratory fitness	Estimated/predicted maximal oxygen uptake, VO2max assessed by the Ekblom-Bak submaximal cycle test	6 months
Secondary	Physical function of the lower body	Assessed by the 5 sit to stand test (seconds)	Baseline
Secondary	Physical function of the lower body	Assessed by the 5 sit to stand test (seconds)	3 months
Secondary	Physical function of the lower body	Assessed by the 5 sit to stand test (seconds)	6 months
Secondary	Upper body muscle strength	Assessed by a hypothetical 12-RM chest press test	Baseline
Secondary	Upper body muscle strength	Assessed by a hypothetical 12-RM chest press test	3 months
Secondary	Upper body muscle strength	Assessed by a hypothetical 12-RM chest press test	6 months
Secondary	Lower body muscle strength	Assessed by a hypothetical 12-RM leg press test	Baseline
Secondary	Lower body muscle strength	Assessed by a hypothetical 12-RM leg press test	3 months
Secondary	Lower body muscle strength	Assessed by a hypothetical 12-RM leg press test	6 months
Secondary	Whole body muscle mass	Assessed by bio impendence device (InBody770) (kg)	Baseline
Secondary	Whole body muscle mass	Assessed by bio impendence device (InBody770) (kg)	3 months
Secondary	Whole body fat mass	Assessed by bio impendence device (InBody770) (kg)	6 months
Secondary	Whole body fat percentage	Assessed by bio impendence device (InBody770) (%)	Baseline
Secondary	Whole body fat percentage	Assessed by bio impendence device (InBody770) (%)	3 months
Secondary	Whole body fat percentage	Assessed by bio impendence device (InBody770) (%)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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