Quality-of-Life Assessment for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Breast Cancer+21 More
Quality-of-Life Assessment - Other
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

The purpose of this two-arm pilot RCT is to evaluate processes and preliminary outcomes of a targeted QOL intervention vs. an attention control among young AA survivors post-treatment for early (I-II) & late (III) stage breast cancer.

Eligible Conditions

  • Breast Cancer
  • Breast
  • Anatomic Stage III Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 0 Secondary · Reporting Duration: Up to 2 years

Month 1
(Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)
MOS Modified Social Support Survey
Medical Outcomes Survey Short-Form (SF-36)
PROMIS Applied Cognition - General Concerns short form (8- item)
PROMIS Global Health10
Up to 2 years
Acceptability/Relevance of Intervention Sessions
Participation in aspects of protocol
Proportion of patients that complete all (five) study contacts of intervention
Proportion of screen-eligible patients enrolled by consent
Use of proposed self-management strategies and perceived effectiveness

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Attention Control
1 of 2
Y-AMBIENT
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · N/A

Y-AMBIENTExperimental Group · 3 Interventions: Questionnaire Administration, Educational Intervention, Quality-of-Life Assessment · Intervention Types: Other, Other, Other
Attention ControlActiveComparator Group · 3 Interventions: Questionnaire Administration, Control Intervention, Quality-of-Life Assessment · Intervention Types: Other, Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
12 TrialsResearching Breast Cancer
206 CompletedClinical Trials

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
281 Previous Clinical Trials
285,778 Total Patients Enrolled
20 Trials studying Breast Cancer
2,627 Patients Enrolled for Breast Cancer
Timiya Nolan, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 18 to 44 years on study entry.
You have completed treatment with chemotherapy and/or radiation for stage I-III breast cancer prior to study entry.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.