INvestigating and Optimizing the Treatment Against Cancer-related FaTigue

A multicenter randomized clinical trial comparing physical exercise, mind-body exercise, and psychosocial interventions during treatment of breast cancer, lung cancer, or lymphoma

The INTACT-study at a glance

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Aim of the study: improving and individualizing the treatment of cancer-related fatigue

Target group: Patients with breast cancer, Hogkin/Non-Hodkin lymphoma, lung cancer during or before their cancer treatment who are affected by cancer-related fatigue

• 3-arm study design with randomized allocation: supervised, structured aerobic and resistance training, 2) supervised, structured mind-body exercise (based on Yoga/Tai-Chi/ Qigong), and 3) group-based, structured psychosocial intervention (based on cognitive behavioral therapy/psycho-education)

Investigators:

Prof. Dr. Karen Steindorf,  Dr. Markus Horneber,  Dr. Imad Maatouk, Dr. Martina Schmidt

Abstract

Cancer-related fatigue is a frequent and burdensome sequela of cancer and cancer therapies. It is a distressing, persistent sense of physical, emotional, or cognitive tiredness and exhaustion that can persist from months to even years and has substantial impacts on patients’ quality of life and functioning. Yet, fatigue often still remains insufficiently treated. Despite being severely impaired, many patients do not even know that they suffer from a syndrome that has a name and is effectively treatable. To-date, the most promising and commonly recommended treatments to prevent or ameliorate fatigue are physical exercise (aerobic and/or resistance training), mind-body exercise (Yoga/Tai-Chi/Qigong), and psychosocial interventions (cognitive behavioral therapy/psycho-education).  For the first time, the multicenter INTACT Study will directly compare the effectiveness of these three fatigue treatments. In contrast to previous studies that mainly investigated breast cancer patients, INTACT will include a more diverse, male and female study population with cancers of the breast, lung or lymphomas. In total, 720 patients suffering from fatigue will be randomly assigned to one of three 3months treatments. The change in fatigue will be assessed by scientifically sound questionnaires and compared between the groups. The INTACT Study will also investigate whether fatigue subtypes or patient subgroups exist in which one of the treatments exerts stronger effects than the others.

Overall, the INTACT Study will identify the treatment that is most efficient for a patient to prevent or ameliorate fatigue. This would not only improve the treatment of fatigue but also improve patients‘ quality of life and possibly his or her survival.

Current status

The INTACT study is funded within the DecadeX BMBF funding guideline "Practice-changing clinical studies", initially for a 7-month concept development phase (April 1 - Oct 31 2020) resulting in a full proposal with a detailed study concept. After review of the full proposal, it is expected that the study setup will start in spring 2021.

Contact

Dr. Alexander Haussmann
phone: +49 6221-56 422383
e-mail: alexander.haussmann@nct-heidelberg.de

Dr. Martina Schmidt
phone: +49 6221-42 2220
e-mail: m.schmidt@dkfz.de

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