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Questionnaire Administration for Stage IIB Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IIB Breast Cancer+20 MoreQuestionnaire Administration - Other
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial studies a text-based intervention to improve adherence to hormone therapy in patients with hormone receptor positive breast cancer.

Eligible Conditions
  • Stage IIB Breast Cancer
  • Stage 1 Breast Cancer
  • Stage IA Breast Cancer
  • Stage IIA Breast Cancer
  • Stage III Breast Cancer
  • Progesterone Receptor Positive Tumor
  • Stage IIIB Breast Cancer
  • Estrogen Receptor Positive Tumor
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage 2 Breast Cancer
  • Stage IB Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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2
Tucatinib
1
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Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 12 months

Up to 12 months
Adjuvant hormone therapy (AHT) adherence
Affective Disorders, Psychotic
Cognitive-affective barriers for AHT adherence
Cognitive-affective barriers for symptom distress
Knowledge and self-efficacy for taking AHT
Perceived benefits
Perceived susceptibility
Self-efficacy for managing symptoms: modified version of Lorig's Chronic Disease Self-Efficacy Scale
Social support
Symptom distress

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Chemotherapy
3
Tucatinib
2
X-ray Therapy

Trial Design

3 Treatment Groups

Phase II Group II (usual care)
1 of 3
Phase II Group 1 (text messages)
1 of 3
Phase 1 (focus groups)
1 of 3

Active Control

Experimental Treatment

340 Total Participants · 3 Treatment Groups

Primary Treatment: Questionnaire Administration · No Placebo Group · N/A

Phase II Group 1 (text messages)Experimental Group · 2 Interventions: Questionnaire Administration, Text Message · Intervention Types: Other, Other
Phase 1 (focus groups)Experimental Group · 2 Interventions: Questionnaire Administration, Focus Group · Intervention Types: Other, Behavioral
Phase II Group II (usual care)ActiveComparator Group · 2 Interventions: Questionnaire Administration, Best Practice · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focus Group
2013
Completed Phase 1
~4140

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
407 Previous Clinical Trials
135,169 Total Patients Enrolled
Kuang-Yi Wen, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
1 Previous Clinical Trials
65 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least 12 months of AHT.
You are able to read and understand English.
You have a breast cancer diagnosis.\n
References

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