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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Colorectal Cancer; Prostate Cancer
• Intervention / Treatment: Behavioral: Exercise

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institute/ Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; 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; 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
No Intervention: Control; The control group will receive routine clinical care according to (inter-) national guidelines

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Swedish Cancer Society; SATS
• Investigators: Principal Investigator: Yvonne Wengström, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Cancer; Fitness; Home-based; Distance-based
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Prostatic Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: Dnr 2019-04151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will become available within 5 years of study completion and will be available for visibility and accessibility for 10 years.
• IPD Sharing Access Criteria: Researchers will have to apply through SND using DORIS to access the data. Once approved, the data is released.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No