Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial

Table 1 Data collection schedule for the ABLE02 study

	Inclusion +/- 7d	W6 +/- 7d	M3/W12 +/- 15d	W18 +/- 7d	M6/W24 +/- 21d	M9/W36 +/- 21d	M12/W48 +/- 1M	M18 +/- 1M	Progression
Socio demographic and clinical data
Socio demographic data	X
Clinical data	X		X		X	X	X	X (survival)	X
Physical evaluation
Anthropometrics	X		X		X		X
Physical fitness (6MWT, sit to stand, handgrip)	X		X		X		X
Self-reported outcomes
Quality of life (QLQ-C30)	X	X	X	X	X	X	X
Physical activity level (GODIN)	X		X		X		X
Undernutrition and dietary patterns	X				X
Fatigue (QLQ-FA12)	X		X		X		X
Sleep quality (PSQI)	X				X
Taking medicines and dietary supplements	X		X		X		X		X
Lifestyle	X
Acceptability ABLE02					X
Transtheoretical model behaviour change	X		X		X
Personality traits (BFI)	X				X
Cancer-Related Cognitive Impairment (FACT-Cog)	X				X		X
Biological assessements
Blood sample	X		X		X		X		X
CT scan
CT scan	X		X		X		X		X
Activity tracker (only for intervention arm)
Steps per day	Continuously					Without personalized advices
Type of physical activity	Continuously
Number of walking sessions per week	3/week
Time and distance of walking sessions per week	Continuously
Time and sleep quality	Continuously
Physical activity follow up	Phone: W2, M1, M2, M3, M4, M5, M6 Mail : Continuously

ISSN: 1471-2407