NCT04120298

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2020Jul 2027

First Submitted

Initial submission to the registry

September 12, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3.1 years

First QC Date

September 12, 2019

Last Update Submit

December 4, 2023

Conditions

Metastatic Breast Cancer

Keywords

exercisecancer-related fatiguequality of life

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (27)

  • Separate HRQoL domains and Summary Score

    0-9 months

  • Cancer-related fatigue

    0-9 months

  • Breast cancer specific symptoms

    0-9 months

  • Anxiety, depression

    0-9 months

  • Sleep

    0-9 months

  • +22 more secondary outcomes

Other Outcomes (5)

  • Overall and breast-cancer specific survival

    0-60 months

  • Progression-free survival

    0-60 months

  • Safety of exercise intervention

    0-9 months

  • +2 more other outcomes

Study Arms (2)

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

Behavioral: Supervised exercise

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.

Interventions

Supervised exerciseBEHAVIORAL

An individualised exercise programme supervised by a trained instructor

Supervised exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of breast cancer stage IV
  • ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
  • Able and willing to perform the exercise program and wear the activity tracker

You may not qualify if:

  • A potential subject who meets any of the following criteria is not eligible for enrolment into this study:
  • Unstable bone metastases inducing skeletal fragility as determined by the treating clinician
  • Untreated symptomatic known brain metastasis
  • Estimated life expectancy \< 6 months as determined by the treating clinician
  • Serious active infection
  • Too physically active (i.e. \>210 minutes/week of moderate-to-vigorous intentional exercise
  • Severe neurologic or cardiac impairment according ACSM criteria
  • Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise
  • Uncontrolled severe pain
  • Any other contraindications for exercise as determined by the treating physician
  • Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 40714912DERIVED

  • 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.

    PMID: 39805062DERIVED

  • 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.

    PMID: 39054374DERIVED

  • 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.

    PMID: 37170950DERIVED

  • 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.

    PMID: 35906659DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Anne May, PhD

    UMC Utrecht Julius Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Epidemiologist

Study Record Dates

First Submitted

September 12, 2019

First Posted

October 9, 2019

Study Start

January 8, 2020

Primary Completion

February 28, 2023

Study Completion (Estimated)

July 1, 2027

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)