Quality-of-Life Assessment for Stage III Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Methodist Hospital, Philadelphia, PAStage III Breast Cancer+10 MoreQuality-of-Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at how well telehealth works in improving adherence to endocrine therapy for participants with hormone receptor positive breast cancer who have undergone surgery.

Eligible Conditions
  • Stage III Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage I Breast Cancer
  • Stage 0 Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage II Breast Cancer
  • Stage IB Breast Cancer
  • Stage IA Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to one year

At 12 months
Satisfaction with cancer care
Up to one year
Adherence to endocrine therapy (ET)
ET side effects
Quality of life

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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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

3 Treatment Groups

Arm I (Standard of Care office Visits)
1 of 3
Arm III (Smart Pill Bottle, messaging)
1 of 3
Arm II (Standard of Care Office Visits, survey, telehealth)
1 of 3

Active Control

Experimental Treatment

285 Total Participants · 3 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 2

Arm III (Smart Pill Bottle, messaging)Experimental Group · 4 Interventions: Behavioral Intervention, Educational Intervention, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Behavioral, Other, Other, Other
Arm II (Standard of Care Office Visits, survey, telehealth)Experimental Group · 5 Interventions: Best Practice, Questionnaire Administration, Quality-of-Life Assessment, Survey Administration, Telemedicine · Intervention Types: Other, Other, Other, Other, Other
Arm I (Standard of Care office Visits)ActiveComparator Group · 3 Interventions: Best Practice, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2017
Completed Phase 4
~3220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to one year

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
409 Previous Clinical Trials
135,790 Total Patients Enrolled
Maysa Abu-Khaaf, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your breast cancer staging must match the most recent American Joint Committee on Cancer (AJCC) guidelines.
You may receive radiation therapy and medication after surgery.
You have been taking hormone therapy for more than 4 years.
References

Frequently Asked Questions

How many venues are implementing this scientific investigation?

"Five distinct healthcare centres are currently enrolling patients in this clinical trial. These include Jefferson Health - South Jersey, Jefferson Health - Northeast, and Thomas Jefefrson University situated within Washington Township, Torresdale and Willow Grove respectively; plus two additional sites." - Anonymous Online Contributor

Unverified Answer

Is enrollment available to individuals interested in participating in this trial?

"According to the information presented on clinicaltrials.gov, this medical trial is presently searching for participants. The study was initially published on July 31st 2019 and its details were last revised Oct 18th 2022." - Anonymous Online Contributor

Unverified Answer

Has the Quality-of-Life Assessment earned FDA authorization?

"Our team at Power assigned Quality-of-Life Assessment a score of 2 due to the lack of efficacy data in Phase 2 clinical trials, although there is evidence that suggests it is safe." - Anonymous Online Contributor

Unverified Answer

How many people have enrolled in this trial thus far?

"Affirmative. According to clinicaltrials.gov, the trial is open for enrolment and was initially posted on July 31st 2019 with a recent update on October 18th 2022. A total of 285 patients will be accepted across 5 different healthcare settings." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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