Clinical trial NCT05064670: Exercise as Medicine for People With Cancer Sweden
Official title: EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Breast Cancer
Colorectal Cancer
Keywords: Exercise
Cancer
Fitness
Distance-based
Home-based
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Society
name: SATS
First posted: 2021-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, 3 months
measure: Health-related quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Cancer related fatigue
timeFrame: Baseline
measure: Cancer related fatigue
timeFrame: 3 months
measure: Cancer related fatigue
timeFrame: 6 months
measure: Symptoms and symptom burden (total symptoms scale)
timeFrame: Baseline
measure: Symptoms and symptom burden (total symptoms scale)
timeFrame: 3 months
measure: Symptoms and symptom burden (total symptoms scale)
timeFrame: 6 months
measure: Cardiorespiratory fitness
timeFrame: Baseline
measure: Cardiorespiratory fitness
timeFrame: 3 months
measure: Cardiorespiratory fitness
timeFrame: 6 months
measure: Physical function of the lower body
timeFrame: Baseline
measure: Physical function of the lower body
timeFrame: 3 months
measure: Physical function of the lower body
timeFrame: 6 months
measure: Upper body muscle strength
timeFrame: Baseline
measure: Upper body muscle strength
timeFrame: 3 months
measure: Upper body muscle strength
timeFrame: 6 months
measure: Lower body muscle strength
timeFrame: Baseline
measure: Lower body muscle strength
timeFrame: 3 months
measure: Lower body muscle strength
timeFrame: 6 months
measure: Whole body muscle mass
timeFrame: Baseline
measure: Whole body muscle mass
timeFrame: 3 months
measure: Whole body fat mass
timeFrame: 6 months
measure: Whole body fat percentage
timeFrame: Baseline
measure: Whole body fat percentage
timeFrame: 3 months
measure: Whole body fat percentage
timeFrame: 6 months
measure: Self reported physical activity
timeFrame: Baseline
measure: Self reported physical activity
timeFrame: 3 months
measure: Self reported physical activity
timeFrame: 6 months
measure: Self efficacy of exercise
timeFrame: Baseline
measure: Self efficacy of exercise
timeFrame: 3 months
measure: Self efficacy of exercise
timeFrame: 6 months
measure: Quality adjusted life years
timeFrame: Baseline
measure: Quality adjusted life years
timeFrame: 3 months
measure: Quality adjusted life years
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute/ Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Yvonne Wengström, PhD
role: PRINCIPAL_INVESTIGATOR
References: