A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design

Di Meglio, Antonio; Martin, Elise; Crane, Tracy E.; Charles, Cecile; Barbier, Aude; Raynard, Bruno; Mangin, Anthony; Tredan, Olivier; Bouleuc, Carole; Cottu, Paul H.; Vanlemmens, Laurence; Segura-Djezzar, Carine; Lesur, Anne; Pistilli, Barbara; Joly, Florence; Ginsbourger, Thomas; Coquet, Bernadette; Pauporte, Iris; Jacob, Guillemette; Sirven, Aude; Bonastre, Julia; Ligibel, Jennifer A.; Michiels, Stefan; Vaz-Luis, Ines

doi:10.1186/s13063-022-06090-6

Trials

Table 1 MEDEA Study outcomes, measures, and assessment

From: A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design

Outcome type	Outcome		Measure	Type of assessment	Schedule of data collection
Outcome type	Outcome		Measure	Type of assessment	Baseline, M0	M6	M12	M18
Primary	Cancer-related Fatigue	Global fatigue	EORTC QLQ-C30¹	Self-reported	X	X	X	X
Secondary	Cancer-related Fatigue	Fatigue dimensions: physical, emotional, cognitive	EORTC QLQ-FA12²	Self-reported	X	X	X	X
	Quality of life, anxiety, and depression	Other quality of life domains*	EORTC QLQ-C30¹	Self-reported	X	X	X	X
		Other quality of life domains*	EORTC QLQ-B45³	Self-reported	X	X	X	X
		Anxiety/Depression	HADS⁴	Self-reported	X	X	X	X
	Health behaviors	Dietary habits	Food questionnaire⁵	Self-reported	X	X	X	X
		Physical activity	WHO GPAQ-16⁶	Self-reported	X	X	X	X
		Intensity of physical activity	Actigraph Accelerometer⁷	Device-based	X	X	X	X
		Energy expenditure	Actigraph Accelerometer⁷	Device-based	X	X	X	X
		Daily steps	Actigraph Accelerometer⁷	Device-based	X	X	X	X
	Weight and body composition	Weight	Clinical visit	Hospital-based	X	X	X	X
		Body mass index	Clinical visit	Hospital-based	X	X	X	X
		Waist and hip circumference	Clinical visit	Hospital-based	X	X	X	X
	Cost-effectiveness	Length of all-cause hospitalizations	Direct medical costs	**	Throughout the whole study duration
		Drug consumption: antidepressants, anxiolytics, pain-killers, and anti-inflammatory drugs (name, start date, duration of use)	Direct medical costs	**	Throughout the whole study duration
		Sick leave (number, duration, and reason)	Indirect costs	**	Throughout the whole study duration
		Utility/QALY	EuroQol 5D 3L⁸	Self-reported	X	X	X	X
Exploratory	Survival outcomes	Invasive DFS	Relapses	**	Throughout the whole study duration
	Survival outcomes	OS	Death	**	Throughout the whole study duration
	Satisfaction and adherence	Motivation and satisfaction with the intervention	Qualitative	Focus group	Halfway through the intervention (month 6) + once at intervention completion (month 12)
	Satisfaction and adherence	% delivered/planned phone calls % patients who achieve intervention goals % phone calls/total by patient/coaches	Quantitative	Centrally assessed (study manager)	End of study

¹Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J. Natl. Cancer Inst. 1993;85(5):365–376
²Weis J, Tomaszewski KA, Hammerlid E, et al. International Psychometric Validation of an EORTC Quality of Life Module Measuring Cancer Related Fatigue (EORTC QLQ-FA12). J. Natl. Cancer Inst. 2017;109(5)
³Bjelic-Radisic V, Cardoso F, Cameron D, et al. An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45. Ann. Oncol. 2020;31(2):283–288
⁴Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr. Scand. 1983;67(6):361–70
⁵Gazan R, Vieux F, Darmon N, Maillot M. Structural Validation of a French Food Frequency Questionnaire of 94 Items. Front. Nutr. 2017;4:62
⁶Global Physical Activity Questionnaire Analysis Guide GPAQ Analysis Guide Global Physical Activity Questionnaire (GPAQ) Analysis Guide
⁷Esliger DW, Tremblay MS. Technical reliability assessment of three accelerometer models in a mechanical setup. Med. Sci. Sports Exerc. 2006;38(12):2173–2181
⁸EQ-5D
*Including: Global health status, physical, emotional, social, role, cognitive function, Pain, Insomnia, Nausea/Vomit, Dyspnea, Appetite Loss, Constipation, Diarrhea, Financial difficulties, Body Image, Future perspective, Sexual function and enjoyment, systemic therapy side effects, arm and breast symptoms, endocrine therapy, skin, and sexual symptoms
**National health, insurance, hospital-based records, ad hoc questionnaire. M month

Back to article page

ISSN: 1745-6215

Contact us

Submission enquiries: Access here and click Contact Us
General enquiries: info@biomedcentral.com