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NSABP PROTOCOL B-35: FOLLOW-UP FORM Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy Breast Cancer NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A057E605-C97E-3E81-E034-080020C9C0E0

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A057E605-C97E-3E81-E034-080020C9C0E0

Stichworte:

Klinische Studie [Dokumenttyp]

Mammatumoren, Mensch

Verlaufsstudien

Versionen (2)

26.08.12 26.08.12 -
23.03.15 23.03.15 - Martin Dugas

Hochgeladen am:

23. März 2015

DOI:

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Lizenz :

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00053898

Englisch 1

Englisch

Details

Form F35 Submit every 6 months for the first 5 years, every 12 months thereafter, and when a protocol event occurs.

1 Formulare

StudyEvent: NSABP PROTOCOL B-35: FOLLOW-UP FORM
1. Form F35 Submit every 6 months for the first 5 years, every 12 months thereafter, and when a protocol event occurs.

Header

First Three Letters of Patient's Last Name

Patient Study ID

Institution Name

Affiliate Name

Person Completing Form Last Name

Person Completing Form First Name

Person Completing Form Phone

Are data amended? (If Yes, circle the amended items in red.)

Yes

Cancer Follow-up Status

Patient's Vital Status

Alive (Alive)

Dead (Dead)

Date of Last Contact or Death (month day year)

Source of Survival Information (if alive)

Documentation Of Hospital Or Clinic Visit (Documentation of hospital or clinic visit)

Phone Contact To Patient (Phone contact to patient)

Other (Other)

Other

Cause of Death (if dead)

Due To This Disease (Due to breast cancer)

Due To Protocol Treatment (Due to protocol treatment)

Due To Other Cause (Due to other cause)

Unknown (Unknown)

Describe Cause of Death (attach documentation)

Was there evidence of recurrence at the time of death?

Yes, Clinical (Yes, clinical)

Yes, Autopsy (Yes, autopsy)

No (No)

Unknown (Unknown)

Has the patient had a documented clinical assessment for this cancer since the last follow-up form?

Yes

Date of Last Clinical Assessment (if applicable month day year)

Total Mastectomy Not Previously Reported?

None (None)

Left (Left)

Right (Right)

Bilateral (Bilateral)

Date of This Mastectomy (if applicable month day year)

Fracture Not Previously Reported? (mark all that apply)

None (None)

Hip (Hip)

Wrist (Wrist)

Other (Other)

If other, (specify)

Date of Fracture (if applicable month day year If more than one fracture, use earlier date. Attach a copy of the radiology reports.)

Since the last reported follow-up, has the patient had any vaginal hormonal therapy? (e.g., low dose estrogen cream, Vagifem [R], Estring [R])

Yes

Bisphosphonates (e.g., Actonel [R], Fosamax [R])

Yes

Calcitonin (e.g., Miacalcin [R])

Yes

Did patient receive any Tamoxifen/Anastrozole during the past 6 months?

Yes

If yes, what percentage of her required pills did she take? (Select the item that best describes her compliance during the 6-month period.)

All (100%) (All (100%))

Almost All (approximately 90%) (Almost all (approximately 90%))

About Three-fourths (approximately 75%) (About three-fourths (approximately 75%))

About Half (approximately 50%) (About half (approximately 50%))

About One-fourth (approximately 25%) (About one-fourth (approximately 25%))

Only A Few (less Than 25%) (Only a few (less than 25%))

How was this percentage determined?

Patient Estimate (Patient Estimate)

Pill Count (Pill Count)

Both (Both)

Ipsilateral Breast Tumor Recurrence

Has the patient been diagnosed with an invasive or non-invasive recurrence in the ipsilateral breast that has not been previously reported?

Yes

Date of IBTR (if applicable month day year)

First Local-regional Recurrence

Has the patient been diagnosed with first local-regional recurrence since submission of the last follow-up form? (other than IBTR)

Yes

Site(s) Diagnosed (mark all first ipsilateral sites that apply)

Chest wall (Chest wall)

Axilla (Axilla)

Axillary nodes (Axillary nodes)

Internal mammary nodes (Internal mammary nodes)

Infraclavicular nodes (Infraclavicular nodes)

Supraclavicular nodes (Supraclavicular nodes)

Date of Diagnosis (if applicable month day year)

First Distant Recurrence

Has the patient been diagnosed with first distant recurrence since submission of the last follow-up form?

Yes

Date of First Distant Recurrence (if applicable month day year)

Site(s) of First Distant Recurrence

New Primary Cancer Or Mds

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

Yes

Date of Diagnosis (if applicable month day year)

Site(s) of New Primary

Adverse Events

Adverse Event

Abdominal Distension (Abdominal distension)

Abdominal Infection (Abdominal infection)

Abdominal Pain (Abdominal pain)

Abdominal Soft Tissue Necrosis (Abdominal soft tissue necrosis)

786 weitere Items in der Detailansicht.

Grade (highest grade this cycle INCLUDE GRADE 0's)

Absent Adverse Event (0)

Mild Adverse Event (1)

Moderate Adverse Event (2)

Severe Adverse Event (3)

Life Threatening Adverse Event (4)

Death Related To Adverse Event (5)

Has the patient experienced any severe (Grade =3) adverse event, possibly related to study medication, that has not been previously reported? (If yes, identify CTC Terms, 4-Character Codes, circle highest applicable grades, and attach documentation.)

Yes

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