Concept development of a multicenter randomized clinical trial comparing physical activity, yoga, and a psychosocial intervention during treatment for breast cancer, lung cancer, colorectal cancer, or non-Hodgkin lymphoma.

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

Study coordination: Dr. Alexander Haussmann

Cancer-related fatigue is one of the most common symptoms of cancer patients. It is a persistent feeling of physical, emotional or cognitive fatigue and exhaustion that can last from months to years and has a significant impact on the quality of life and functioning in social and professional life of those affected. Yet it is still often inadequately treated. Cancer patients suffering from fatigue are often unaware that it is a condition for which there are effective treatment options. Based on a large number of studies, reviews and meta-analyses, exercise (strength and endurance training), yoga and psychosocial interventions have emerged as effective non-pharmacological therapeutic approaches.

During the concept development phase, the requirements were established for conducting a multicenter randomized clinical trial that could compare the different treatment modalities in a heterogeneous study population of individuals with breast, lung, colorectal, and lymphoma cancers. This included a comprehensive literature search of non-pharmacological interventions for cancer-related fatigue resulting in a systematic review and meta-analysis. From these analyses, the content and modalities of implemented interventions promising high efficacy in reducing cancer-related fatigue were derived. At the same time, a study advisory board consisting of scientific experts from the fields of oncology, nursing, psychology and fatigue relevant to the INTACT study was involved in the concept development. The perspective of patient representatives was also given high priority, on the one hand in the form of a 6-member patient advisory board, and on the other hand by conducting and evaluating semi-structured interviews with a total of 38 patients. These included aspects of the timing of the study implementation as well as needs and wishes for content, design and format of study and information materials.

The findings from the interviews and from the systematic review, as well as the views of the experts and patient representatives, led to the development of fatigue-specific manuals for exercise training as well as for a yoga and a psychosocial intervention.

The concept phase of the INTACT study was funded within the framework of the Decade Against Cancer under the BMBF funding guideline "Practice-changing clinical trials" from March 1, 2020 to April 30, 2021. The results were published in the form of the meta-analysis below.

Haussmann, A, Schmidt, ME, Illmann, ML, Schröter, M, Hielscher, T, Cramer, H, Maatouk, I, Horneber, M, & Steindorf, K. (2022). Meta-Analysis of Randomized Controlled Trials on Yoga, Psychosocial, and Mindfulness-Based Interventions for Cancer-Related Fatigue: What Intervention Characteristics Are Related to Higher Efficacy? Cancers, 14(8). doi: https://doi.org/10.3390/cancers14082016