Quality-of-Life Assessment for Stage 1 Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stage 1 Breast Cancer+8 MoreQuality-of-Life Assessment - Other
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial looks at how well patients stick to their medication plan when given text reminders and/or phone counseling.

Eligible Conditions
  • Stage 1 Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • HER2 Negative Breast Cancer
  • Hormone Receptor Positive Breast Cancer
  • Breast Cancer
  • Stage 2 Breast Cancer

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: At 24 months post-randomization

At 12 months post-randomization
Endocrine therapy (ET) adherence at 12 months post-randomization
At 24 months post-randomization
Endocrine therapy (ET) adherence at 24 months post-randomization

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
48%Blood or bone marrow
42%Metabolic or laboratory-testing result
40%Hepatic
36%General
28%Constitutional symptoms
26%Neurologic
22%Pulmonary
21%Gastrointestinal
19%Renal or genitourinary
19%Arrhythmia
13%Pain
8%Infection or febrile neutropenia
7%Skin
7%Musculoskeletal
2%Death
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT00019682) in the Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin) ARM group. Side effects include: Blood or bone marrow with 48%, Metabolic or laboratory-testing result with 42%, Hepatic with 40%, General with 36%, Constitutional symptoms with 28%.

Trial Design

4 Treatment Groups

Arm IV (enhanced usual care)
1 of 4
Arm II (MI)
1 of 4
Arm III (TMR + MI)
1 of 4
Arm I (TMR)
1 of 4

Active Control

Experimental Treatment

1180 Total Participants · 4 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 3

Arm II (MI)Experimental Group · 4 Interventions: Motivational Interviewing, Questionnaire Administration, Quality-of-Life Assessment, Educational Intervention · Intervention Types: Behavioral, Other, Other, Other
Arm III (TMR + MI)Experimental Group · 5 Interventions: Text Message-based Navigation Intervention, Motivational Interviewing, Questionnaire Administration, Quality-of-Life Assessment, Educational Intervention · Intervention Types: Other, Behavioral, Other, Other, Other
Arm I (TMR)Experimental Group · 4 Interventions: Text Message-based Navigation Intervention, Questionnaire Administration, Quality-of-Life Assessment, Educational Intervention · Intervention Types: Other, Other, Other, Other
Arm IV (enhanced usual care)ActiveComparator Group · 4 Interventions: Best Practice, Questionnaire Administration, Quality-of-Life Assessment, Educational Intervention · Intervention Types: Other, Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Interviewing
2020
Completed Phase 3
~9380

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 24 months post-randomization

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,140,283 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
504 Previous Clinical Trials
215,764 Total Patients Enrolled
Katherine E. Reeder-Hayes, MDStudy ChairUniversity of North Carolina, Chapel Hill

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone.
You have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
65+100.0%
What site did they apply to?
UCSF Cancer Center - Berkeley100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%