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| ID | Type | Description | Link |
|---|---|---|---|
| NL69600.041.19 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
| Australian Catholic University | OTHER |
| Karolinska Institutet | OTHER |
| The Netherlands Cancer Institute |
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Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).
The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.
Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised exercise group | Experimental | The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine. Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial |
|
| Control group | No Intervention | Patients randomized to the control group will also receive an activity tracker (like the intervention group). We will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised exercise | Behavioral | An individualised exercise programme supervised by a trained instructor |
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| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related physical fatigue | Physical fatigue measured with the EORTC QLQ-FA12 | 0- 6 months (measured at baseline, 3 and 6 months) |
| Health-related Quality of Life | Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score | 0- 6 months (measured at baseline, 3 and 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Separate HRQoL domains and Summary Score | EORTC QLQ-C30 function and symptom scores scores | 0-9 months |
| Cancer-related fatigue | EORTC QLQ-FA12 scores |
| Measure | Description | Time Frame |
|---|---|---|
| Overall and breast-cancer specific survival | Exploratory outcome | 0-60 months |
| Progression-free survival | Exploratory outcome | 0-60 months |
Inclusion Criteria:
Exclusion Criteria:
A potential subject who meets any of the following criteria is not eligible for enrolment into this study:
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| Name | Affiliation | Role |
|---|---|---|
| Anne May, PhD | UMC Utrecht Julius Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41975453 | Derived | Zopf EM, Joernaker G, Clauss D, Trevaskis M, Hiensch AE, Schmidt ME, Monninkhof EM, Zimmer P, Belloso J, Heyrman E, Fernandez Gonzalo R, Wiskemann J, Muller J, Bolam KA, Gorecki M, Altena R, Muttiah C, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Stuiver MM, Steindorf K, Bloch W, Wengstrom Y, May AM, Rundqvist H. Exercise effects on lean body mass, muscle strength and functional performance in patients with metastatic breast cancer: the randomized controlled PREFERABLE-EFFECT study. Breast Cancer Res. 2026 Apr 13;28(1):98. doi: 10.1186/s13058-026-02235-6. | |
| 40714912 |
| Label | URL |
|---|---|
| Website of the EFFECT study within the PREFERABLE project | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OTHER |
| Medical University of Gdansk | OTHER |
| FundaciĆ³n Onkologikoa Fundazioa | UNKNOWN |
| Europa Donna | UNKNOWN |
| German Sport University, Cologne | OTHER |
| University Hospital Heidelberg | OTHER |
| Nurogames GmbH, Cologne | UNKNOWN |
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| 0-9 months |
| Breast cancer specific symptoms | EORTC QLQ-BR45 | 0-9 months |
| Anxiety, depression | PHQ-4 | 0-9 months |
| Sleep | PSQI | 0-9 months |
| Pain: severity and its impact on functioning. | BPI | 0-9 months |
| Neuropathic pain | painDETECT | 0-9 months |
| Pain Catastrophizing | PCS | 0-9 months |
| Treatment-related toxicities gradeā„3 | Common Toxicity Criteria for adverse events (CTCAE) | 0-9 months |
| Weight | weight measured in KG | 0-6 months |
| Height | Height measured in meters | 0-6 months |
| Waist circumference | waist circumference measured in cm | 0-6 months |
| Body composition (fat free mass and fat mass) | Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA | 0-6 months |
| Physical activity (subjective) | Questionnaire | 0-6-9 months |
| Physical activity (objective) | activity tracker | 0-6-9 months |
| Resting heart rate | Resting heart rate | 0-6 months |
| Blood pressure | Blood pressure (diastolic and systolic) measured at rest | 0-6 months |
| Physical performance | Short Physical Performance Battery, handgrip- and leg strength test | 0-6 months |
| Physical fitness | Steep ramp test and endurance cycle test, add-on (not obligatory): CPET | 0-6 months |
| Work status/ healthcare resources consumption | iPCQ/iMCQ | 0-9 months |
| Intervention costs | Cost analyses | 0-9 months |
| Health status | EQ-5D-5L | 0-9 months |
| Satisfaction with exercise intervention | Self-developed questionnaire | 0-9 months |
| Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators) | Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) ) | 0-6 months |
| Disease control | Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry | 0-9 months |
| Cancer treatment | The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry | 0-9 months |
| Quality of working life | QWLQ-CS (add-on in several centers) | 0-9 months |
| Safety of exercise intervention | (Serious) Adverse events potentially related to the exercise intervention | 0-9 months |
| Urinary incontinence | Exploratory outcome (add on in some centers) - measured with ICIQ-UI | 0-9 months |
| Maximal isokinetic and isometric leg strength, muscle thickness of m. rectus femoris (RF) and m. vastus lateralis (VL) | Exploratory outcome (add on in one center) - Isokinetic and isometric legstrength measured with peak torque / Muscle thickness with ultrasound protocol | 0-9 months |
| Derived |
| Kias A, Schmidt ME, Hiensch AE, Clauss D, Monninkhof EM, Pelaez M, Belloso J, Gunasekara N, Sweegers MG, Trevaskis M, Rundqvist H, Muller J, Wiskemann J, van der Wall E, Aaronson NK, Lachowicz M, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, May AM, Steindorf K. Factors Associated With Employment and Quality of Working Life in Patients With Metastatic Breast Cancer. Cancer Med. 2025 Aug;14(15):e71074. doi: 10.1002/cam4.71074. |
| 39805062 | Derived | Schouten AEM, Hiensch AE, Frederix GWJ, Monninkhof EM, Schmidt ME, Clauss D, Gunasekara N, Belloso J, Trevaskis M, Rundqvist H, Wiskemann J, Muller J, Sweegers MG, Fremd C, Altena R, Bijlsma RM, Sonke G, Lahuerta A, Mann GB, Francis PA, Richardson G, Malter W, Kufel-Grabowska J, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, van der Meulen MP, May AM. Supervised Exercise for Patients With Metastatic Breast Cancer: A Cost-Utility Analysis Alongside the PREFERABLE-EFFECT Randomized Controlled Trial. J Clin Oncol. 2025 Apr 10;43(11):1325-1336. doi: 10.1200/JCO-24-01441. Epub 2025 Jan 13. |
| 39054374 | Derived | Hiensch AE, Depenbusch J, Schmidt ME, Monninkhof EM, Pelaez M, Clauss D, Gunasekara N, Zimmer P, Belloso J, Trevaskis M, Rundqvist H, Wiskemann J, Muller J, Sweegers MG, Fremd C, Altena R, Gorecki M, Bijlsma R, van Leeuwen-Snoeks L, Ten Bokkel Huinink D, Sonke G, Lahuerta A, Mann GB, Francis PA, Richardson G, Malter W, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, May AM. Supervised, structured and individualized exercise in metastatic breast cancer: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2957-2966. doi: 10.1038/s41591-024-03143-y. Epub 2024 Jul 25. |
| 37170950 | Derived | Pelaez M, Stuiver MM, Broekman M, Schmitz KH, Zopf EM, Clauss D, Wengstrom Y, Rosenberger F, Steindorf K, Urruticoechea A, May AM. Early Detection of Brain Metastases in a Supervised Exercise Program for Patients with Advanced Breast Cancer: A Case Report. Med Sci Sports Exerc. 2023 Oct 1;55(10):1745-1749. doi: 10.1249/MSS.0000000000003213. Epub 2023 May 12. |
| 35906659 | Derived | Hiensch AE, Monninkhof EM, Schmidt ME, Zopf EM, Bolam KA, Aaronson NK, Belloso J, Bloch W, Clauss D, Depenbusch J, Lachowicz M, Pelaez M, Rundqvist H, Senkus E, Stuiver MM, Trevaskis M, Urruticoechea A, Rosenberger F, van der Wall E, de Wit GA, Zimmer P, Wengstrom Y, Steindorf K, May AM. Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study. Trials. 2022 Jul 29;23(1):610. doi: 10.1186/s13063-022-06556-7. |
| Twitter account PREFERABLE project | View source |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |