Trial Title:
Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
NCT ID:
NCT05926024
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Quality of life
Adverse Events
Cancer free
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Recall Patient Reported Outcomes
Description:
Questionnaire items inquire about (1) the number of days of the week participants engage
in walking for pleasure or exercise and (2) the number of minutes per day that
participants engage in walking for pleasure or exercise. The same two questions are
repeated pertaining to exercise in general. Completion of these items takes 1 minute to
complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes
Description:
Health Behavior Questionnaire (HBQ)30 -- Questionnaire items pertain to the history of
smoking, engagement in vigorous physical activity, alcohol consumption, and mortality
status of parents, and take less than 1 minute to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes
Description:
Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and
function measure developed and validated over 20 years ago that has been used in hundreds
of cancer studies worldwide. It consists of four well-being domains -- physical,
social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument
that is formatted for self-administration and uses a 5-point Likert-type scale (0=not at
all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is
"during the past 7 days". It takes 6-8 minutes for an average patient to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes
Description:
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item scale
that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite
a bit, 4=very much). The recall period is "during the past 7 days". This measure takes
about 1 minute to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)
Description:
PROMIS Cognitive Function (Short Form 8a) includes 8 items on a 5-point Likert-type scale
ranging from very often/several times a day = 1 to never = 5, with higher scores
indicating greater perceived loss of cognitive function. This measure takes less than 1
minute to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12)
Description:
Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12)
is a questionnaire that includes 12 items inquiring about symptoms in the past 7 days
(0=not at all to 4=very much) pertaining to numbness or tingling in hands/feet,
discomfort in hands/feet, joint pain or muscle cramps, weakness all over, trouble
hearing, ringing/buzzing in ears, buttoning buttons, trouble feeling the shape of small
objects in hands, trouble walking, and pain in hands/feet in cold temperatures. This
measure takes about t 1 minute to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcomes PROMIS
Description:
PROMIS Measures Global Health (10 items), Anxiety (6 items), Depression (8 items), and
Stress (10 items). All items are on a 5-point Likert-type scale form never to very often.
Completion of all 34 items should take no more than 3 minutes to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcomes FACT-Endocrine Symptoms
Description:
FACT-Endocrine Symptom is a 19-item questionnaire inquiring about hot flashes, cold
sweats, night sweats; vaginal discharge, itching/irritation, bleeding or spotting,
dryness; pain or discomfort with intercourse, loss of interest in sex; weight gain;
lightheadedness; vomiting; diarrhea; headaches; bloating; breast sensitivity/tenderness;
mood swings; irritability; pain in joints. Responses are on a 5- point Likert-type scale
from not at all to very much. This measure takes about two minutes to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcomes Penn Arthralgia Aging Survey
Description:
Penn Arthralgia Aging Survey is an 8-item scale inquiring about joint pain, with a
4-point response scale from not at all to complete. Items pertaining to slowing down,
stopping, being hesitant, unable to do this, and feeling unusually aged. This measure
takes less than a minute to complete.
Arm group label:
Cohort B
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE)
Description:
PRO-CTCAE (patient-reported CTCAE) is Patients will be asked about the side effects of
chemotherapy treatment at baseline, every 3 weeks during chemotherapy, at the end of
chemotherapy, and at 6 months post-chemotherapy. Patients are asked to rate "in the past
7 days" the average severity, frequency, and intensity and a scale from 1=none/never/not
at all to 5=very severe/very much/almost all of the time. Symptom list: Abdominal pain,
Constipation, Diarrhea. Mucositis oral, Nausea, Vomiting, Edema limbs, Fatigue, Pain,
Arthralgia, Myalgia, Peripheral sensory neuropathy, Anxiety, Depression, Insomnia,
Dyspnea, Rash maculopapular, Hot flashes. Completion of these measures takes 5 minutes
for an average patient
Arm group label:
Cohort B
Intervention type:
Diagnostic Test
Intervention name:
p16 tumor suppressor gene
Description:
Blood samples will be obtained to test the p16 tumor suppressor gene from the subjects It
is voluntary..
Arm group label:
Cohort A
Arm group label:
Cohort B
Summary:
This study evaluates whether there are pre-treatment factors such as patient
characteristics, specific breast cancer type, specific treatments, toxicities, or adverse
events during treatment that may impact the quality of life and function, 3 years or more
after the treatment, in cancer-free subjects.
There will be 2 groups. Cohort A: Women who participated in previous studies namely
NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consent for this
study activities. Cohort B: Women with breast cancer, who did not receive chemotherapy,
will be consented to be included in the study, and their electronic medical data will be
used.
Furthermore, the long-term effects of treatment and a biomarker of aging cyclin-dependent
kinase inhibitor 2A (CDKN2A,p16INK4a) and relation will be assessed.
Criteria for eligibility:
Study pop:
Women have been diagnosed with breast cancer and cancer-free for equal or more than 3
years.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria
outlined below.
1. Informed consent was obtained per Institutional Review Board guidelines to
participate in the study and HIPAA authorization for the release of personal health
information.
2. Subjects are willing and able to comply with study procedures based on the judgment
of the investigator or protocol designee.
3. Age ≥21 years at the time of consent.
4. Able to read and comprehend English.
5. No breast cancer recurrence or metastasis; no other cancer diagnosis other than
basal cell or squamous cell cancers.
Exclusion Criteria:
1. Unable to read or comprehend English.
2. Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal
cell or squamous cell cancer.
Gender:
Female
Gender based:
Yes
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yesi Lopez
Phone:
919-966-4432
Email:
yesy_lopez@med.unc.edu
Investigator:
Last name:
Hyman Muss, MD
Email:
Principal Investigator
Start date:
January 6, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05926024
