Here is the design of a clinical trial:

Official Title: A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer

Included conditions:
- Metastatic Breast Cancer

Study Armgroups:
- {'label': 'Physical activity intervention with connected devices', 'type': 'EXPERIMENTAL', 'description': 'Women randomized to the intervention arm will follow a 6-month physical activity intervention using a connected device that includes an activity tracker, a smartphone and a mobile application. Patients will also receive physical activity international recommendations', 'interventionNames': ['Device: Physical activity intervention with connected devices']}
- {'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Women will receive stardard care and physical activity international recommendations, without further intervention'}

Interventions:
- {'type': 'DEVICE', 'name': 'Physical activity intervention with connected devices', 'description': 'Participants randomized in the intervention arm will receive recommandations in physical activity. They will also receive an activity tracker Withings Steel to wear during 6 months. The tracker will be connected to the "Withings Health Mate" application and the ABLE02 application. Participants will be encouraged to practice at least three walking sessions weekly of more than 10 consecutive minutes. Concerning the number of steps per day, the first objective will be determined according to the 6-min walking distance and to participants\' preferences and capacities. The objective will be recalculated monthly according to the number of steps performed the previous week and will be adapted by the physical activity (PA) instructor and participants. Phone calls with the participants are regularly planned. Weekly quizzes on PA and nutrition will be proposed through the ABLE02 application. A messaging system and a phone line will be available for participants to contact the study team.', 'armGroupLabels': ['Physical activity intervention with connected devices']}

Primary Outcomes:
- {'measure': 'time to deterioration of global health status (GHS) score of EORTC QLQ C30', 'description': 'Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.\n\nDeterioration is defined as a 5-point decrease relative to baseline in GHS score, with no subsequent increase above this threshold.', 'timeFrame': 'Month 18'}
- {'measure': 'time to deterioration of fatigue score of EORTC QLQ C30', 'description': 'Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.\n\nA deterioration of fatigue is defined as a 5-point increase relative to baseline fatigue score, with no subsequent decrease above this threshold.', 'timeFrame': 'Month 18'}

Please estimate the sample size based on the assumption: 
Two-sided alpha of 0.05 split among co-primary endpoints (0.04 for TTD1 and 0.01 for TTD2); 90% power for TTD1 and 77% power for TTD2; 30-month accrual, 18-month follow-up, 1% exponential dropout rate.
Sample size
          The study design was based on Burris et al. [64] using the time to deterioration (TTD) on the EORTC QLQ-C30 with comparable population and treatment for the global HRQoL (primary objective) and fatigue symptom domain (co-primary objective).
          The overall two-sided alpha of 0.05 will be split among the co-primary endpoints, with 0.04 for time to definitive deterioration of HRQoL (TTD1) and 0.01 for time to definitive deterioration of fatigue (TTD2). We estimate that about 244 randomized participants with a minimum of 189 deterioration events observed will be required to achieve a 90% statistical power to detect an improvement in median TTD1 from 8 (control) to 13âmonths (intervention) (HRâ=â0.615), using a two-sided alpha of 0.04, and assuming a 30-month accrual and 18-month follow-up, and an 1% exponential dropout rate. This sample size will permit to detect the same improvement in median TTD2 from 8 to 13âmonths with a 77% power and using a two-sided alpha of 0.01 (nQuery Advisor V7.0).