Protocol Index	

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OP RSH PRO00038015 TEMPLETON TAXIS TREATMENT AND FU PHASE	

Types:      Research Oncology Treatment
Synonyms:  TAXIS, PRO00038015, AXILLARY SURGERY

Registration/Randomization : Surgery time 	Repeat 1 time	Cycle length: 3 days	Day -3	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Registration
				Day 0 Surgery 	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Documentation of clip in specimen radiography
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Pathological confirmation of positive nodes (if neoadjuvant treatment). If not previously confirmed.
					
Observation :1w after surgery/ 4w after surgery 	Repeat 1 time	Cycle length: 28 days	Week 1 after surgery	Perform every 28 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Recording of characteristics of TAS and ALND levels
				Week 4 after surgery	Perform every 28 days x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
					
Adjuvant Systemic Treatment	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Recording of neoadjuvant and adjuvant systemic treatments (if indicated).

According to internatl. guidelines
					
RT period : 2w before start of radiotherapy /5w after start RT /3w after end of RT 	Repeat 1 time	Cycle length: 105 days	2 W before start of radiotherapy	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
				RADIOTHERAPY	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 40	Interval: --	Occurrences: --	Comments:	25x2 Gy or 28x1.8 Gy (5w x 5d).

within 6 weeks after the end of chemotherapy and not later than 8 weeks. 
Hypofractionated schedule allowed: 40 Gy in 15 fract. of 2.67 Gy to same volume
				5 W after start of RT (end of treatment)	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
				3 W after end of RT	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
					
FUP : Intervention phase:  9m,12m and year 2-5 after rando	Repeat 1 time	Cycle length: 3640 days	9 month	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				12 month	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				24 month	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				36 month	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				48 month	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				60 month	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				Observation phase 6 yrs	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				Observation phase 7 yrs	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				Observation phase 8 yrs	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				Observation phase 9 yrs	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization
				Observation phase 10 yrs	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast and axilla
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Lymphedema / circumference measures of arms
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Shoulder motion
			Imaging
  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --		  	US AXILLA BILATERAL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Quality of Life (QOL) assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	First new anti-cancer treatment
		  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Further non-cancer breast surgeries
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

Continuously. 
Document from date of patient consent signature up to 10 years after randomization