Information:
Error:
INSTRUCTIONS: The Y-ME counselor will complete and submit this form as required by the protocol. Information in the upper right box muse be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Retain a copy for your records and send the original to the CALGB Data Management Center.
- StudyEvent: CALGB: Y-ME COUNSELOR TELEPHONE CONTACT FORM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CALGBForm
Item
CALGB Form
text
CALGBForm
Item
CALGB Form
text
Y-MEPatientID
Item
Y-ME Patient ID (6.)
text
Y-MEPatientID
Item
Y-ME Patient ID (6.)
text
Item
Patient enrolled in 49907 (1.)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Counselor'sName
Item
Counselor's Name (2.)
text
Dateofsession
Item
Date of session (M)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Timesessionbegan
Item
Time session began ([hour/minute])
text
Timesessionended
Item
Time session ended ([hour/minute])
text
CL Item
Patient (Patient)
C16960 (NCI Thesaurus)
C0030705 (UMLS 2011AA)
C0030705 (UMLS 2011AA)
CL Item
Family Member Or Friend (Family member or friend)
CL Item
Patient Asked The Following About This Clinical Trial (Patient asked the following about this clinical trial)
CL Item
Described Experience Of Being On A Clinical Trial/research Study: How It Differs From Just Being Treated 'off-protocol' (Described experience of being on a clinical trial/research study: How it differs from just being treated 'off-protocol')
CL Item
Consent Form (Consent Form)
C16468 (NCI Thesaurus)
C0009797 (UMLS 2011AA)
C0009797 (UMLS 2011AA)
CL Item
Specific Protocol-related Issues (Specific protocol-related issues)
CL Item
Other Topics Discussed, Specify Below (Other Topics Discussed, specify below)
Item
Patient asked the following about this clinical trial (mark all that apply with an X)
text
Code List
Patient asked the following about this clinical trial (mark all that apply with an X)
CL Item
Objectives; Significance Of Study (Objectives; Significance of study)
CL Item
Specific Treatment (Specific treatment)
CL Item
Medical Tests Required (Medical tests required)
CL Item
Side Effects (Side effects)
CL Item
What Patient Is Required To Do (What patient is required to do)
CL Item
Randomization Issues (Randomization issues)
CL Item
Other, Specify (Other, specify)
Other,specify(patientaskedaboutthisclinicaltrial)
Item
Other, specify (patient asked about this clinical trial) (C.)
text
CL Item
Interpreted/explained Language Used In Consent Form (Interpreted/explained language used in consent form)
CL Item
Patient Can Leave Study At Any Time Without Repercussions (Patient can leave study at any time without repercussions)
CL Item
The Right Of The Patient To Contact A Person In The Hospital If She Feels Her Rights Have Not Been Protected (The right of the patient to contact a person in the hospital if she feels her rights have not been protected)
Item
Specific protocol-related issues (mark all that apply with an X)
text
CL Item
Transportation To/from Hospital (Transportation to/from hospital)
CL Item
Whether Costs Of Participation In Study Would Be Covered By Insurance (Whether costs of participation in study would be covered by insurance)
CL Item
Confidentiality Of Data (Confidentiality of data)
CL Item
Other, Specify (Other, specify)
Other,specify(specificprotocol-relatedissues)
Item
Other, specify (specific protocol-related issues) (E.)
text
OtherTopicsDiscussed,specifybelow
Item
Other Topics Discussed, specify below
text
CALGBForm
Item
CALGB Form
text
CALGBForm
Item
CALGB Form
text
Y-MEPatientID
Item
Y-ME Patient ID (6.)
text
Y-MEPatientID
Item
Y-ME Patient ID (6.)
text
Item
What were the patient's concerns about participating in this clinical trial? (mark all that apply)
text
C2699424 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
C0681850 (UMLS CUI-2)
Code List
What were the patient's concerns about participating in this clinical trial? (mark all that apply)
CL Item
Didn't Understand The Study (a)
CL Item
Treatment Side Effects (b)
CL Item
Fear That Treatment Was Life-threatening (c)
CL Item
The Trial Was Not Asking An Important Question (d)
CL Item
Patient Felt That She Could Get Good Care Without Needing To Be On A Clinical Trial (e)
CL Item
Randomization; Wanted To Be On A Specific Arm Of The Trial (f)
CL Item
Didn't Understand The Consent Form (g)
CL Item
Was Frightened By The Consent Form (h)
CL Item
Transportation Not Available Or Too Expensive (i)
CL Item
Distance Need To Travel To Hospital Was Too Far (j)
CL Item
Costs Of Treatment That Would Not Be Covered By Insurance (k)
CL Item
Confidentiality Of Medical Records (l)
CL Item
Afraid Of Oncologist's Reaction If She Decided Not To Participate In Trial (m)
CL Item
Fears Of Family Members Or Friends Disapproving Of Her Decision About Participating In This Trial (n)
CL Item
Afraid Of Being A 'guinea Pig'; Treated By An Unproven Experimental Therapy (o)
CL Item
Insufficient Support At Home From Friends And Family To Help Patient While Being Treated (p)
CL Item
Other, Specify (q)
CL Item
Don't Know (r)
Other concerns about trial participation
Item
Other, specify (patient's concerns about participating in this clinical trial)
text
Item
Most Important (patient's concerns about participating in this trial)
text
Code List
Most Important (patient's concerns about participating in this trial)
CL Item
Didn't Understand The Study (a)
CL Item
Treatment Side Effects (b)
CL Item
Fear That Treatment Was Life-threatening (c)
CL Item
The Trial Was Not Asking An Important Question (d)
CL Item
Patient Felt That She Could Get Good Care Without Needing To Be On A Clinical Trial (e)
CL Item
Randomization; Wanted To Be On A Specific Arm Of The Trial (f)
CL Item
Didn't Understand The Consent Form (g)
CL Item
Was Frightened By The Consent Form (h)
CL Item
Transportation Not Available Or Too Expensive (i)
CL Item
Distance Need To Travel To Hospital Was Too Far (j)
CL Item
Costs Of Treatment That Would Not Be Covered By Insurance (k)
CL Item
Confidentiality Of Medical Records (l)
CL Item
Afraid Of Oncologist's Reaction If She Decided Not To Participate In Trial (m)
CL Item
Fears Of Family Members Or Friends Disapproving Of Her Decision About Participating In This Trial (n)
CL Item
Afraid Of Being A 'guinea Pig'; Treated By An Unproven Experimental Therapy (o)
CL Item
Insufficient Support At Home From Friends And Family To Help Patient While Being Treated (p)
CL Item
Other, Specify (q)
CL Item
Don't Know (r)
Item
2nd Most Important (patient's concerns about participating in this trial)
text
CL Item
Didn't Understand The Study (a)
CL Item
Treatment Side Effects (b)
CL Item
Fear That Treatment Was Life-threatening (c)
CL Item
The Trial Was Not Asking An Important Question (d)
CL Item
Patient Felt That She Could Get Good Care Without Needing To Be On A Clinical Trial (e)
CL Item
Randomization; Wanted To Be On A Specific Arm Of The Trial (f)
CL Item
Didn't Understand The Consent Form (g)
CL Item
Was Frightened By The Consent Form (h)
CL Item
Transportation Not Available Or Too Expensive (i)
CL Item
Distance Need To Travel To Hospital Was Too Far (j)
CL Item
Costs Of Treatment That Would Not Be Covered By Insurance (k)
CL Item
Confidentiality Of Medical Records (l)
CL Item
Afraid Of Oncologist's Reaction If She Decided Not To Participate In Trial (m)
CL Item
Fears Of Family Members Or Friends Disapproving Of Her Decision About Participating In This Trial (n)
CL Item
Afraid Of Being A 'guinea Pig'; Treated By An Unproven Experimental Therapy (o)
CL Item
Insufficient Support At Home From Friends And Family To Help Patient While Being Treated (p)
CL Item
Other, Specify (q)
CL Item
Don't Know (r)
Item
3rd Most Important (patient's concerns about participating in this trial)
text
CL Item
Didn't Understand The Study (a)
CL Item
Treatment Side Effects (b)
CL Item
Fear That Treatment Was Life-threatening (c)
CL Item
The Trial Was Not Asking An Important Question (d)
CL Item
Patient Felt That She Could Get Good Care Without Needing To Be On A Clinical Trial (e)
CL Item
Randomization; Wanted To Be On A Specific Arm Of The Trial (f)
CL Item
Didn't Understand The Consent Form (g)
CL Item
Was Frightened By The Consent Form (h)
CL Item
Transportation Not Available Or Too Expensive (i)
CL Item
Distance Need To Travel To Hospital Was Too Far (j)
CL Item
Costs Of Treatment That Would Not Be Covered By Insurance (k)
CL Item
Confidentiality Of Medical Records (l)
CL Item
Afraid Of Oncologist's Reaction If She Decided Not To Participate In Trial (m)
CL Item
Fears Of Family Members Or Friends Disapproving Of Her Decision About Participating In This Trial (n)
CL Item
Afraid Of Being A 'guinea Pig'; Treated By An Unproven Experimental Therapy (o)
CL Item
Insufficient Support At Home From Friends And Family To Help Patient While Being Treated (p)
CL Item
Other, Specify (q)
CL Item
Don't Know (r)
Item
What was the outcome at the end of the call? (mark all that apply with an X)
text
CL Item
Patient Decided To Participate In Trial (Patient decided to participate in trial)
CL Item
Patient Decided Not To Participate (Patient decided not to participate)
CL Item
Patient Would Continue To Think About Whether To Participate (Patient would continue to think about whether to participate)
CL Item
Arranged To Speak Again To The Patient (Arranged to speak again to the patient)
CL Item
Sent Some Information Brochures To The Patient [specify Which:] (Sent some information brochures to the patient [specify which:])
CL Item
Referred Patient To Another Agency/professional Concerning Matters Other Than Their Participation In This Clinical Trial (Referred patient to another agency/professional concerning matters other than their participation in this clinical trial)
CL Item
Suggested Patient Speak With A Member Of Their Medical Team Where She Is Being Treated (Suggested patient speak with a member of their medical team where she is being treated)
CL Item
Other, Specify (Other, specify)
Information brochure
Item
Sent some information brochures to the patient [specify which:]
text
C0030258 (UMLS CUI-1)
Other,specify(outcomeattheendofthecall)
Item
Other, specify (outcome at the end of the call)
text
CompletedBy
Item
Completed By (Print or Type Name)
text
Date completed
Item
Date Completed
date
C0011008 (UMLS CUI-1)