Anatomic Stage I Breast Cancer AJCC v8NCT05243056

A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment

A study testing Best Practice, Educational Intervention and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Alabama at Birmingham at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This clinical trial studies the use of a quality of life intervention called Y-AMBIENT to help young African American with stage I-III breast cancer manage daily life. Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials… Read more about this study

Who is it for?: Ages 18 to 44 years, women only
Conditions the study is for: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
What is being tested?: Best Practice, Educational Intervention and Quality-of-Life Assessment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2022to 30 Dec 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 44 years
Women only
No healthy volunteers
Adult

Who may be able to join

Biologically born women
Self-identify as AA
Are aged 18 to 44 years on study entry
Are diagnosed with breast cancer stage I-III
Are in treatment with chemotherapy and/or radiation for stage I-III breast cancer at study entry
Are English- speaking
Have telephone and internet access

Who cannot join

Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment

Read the detailed description

PRIMARY OBJECTIVES:

Evaluate feasibility and acceptability of Y-AMBIENT and enhanced usual care among young African American breast cancer survivors.

II. Explore the degree to which the Y-AMBIENT versus (vs.) enhanced usual care affects preliminary health-related outcomes among young African American (AA survivors).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Y-AMBIENT): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.

ARM II (ENHANCED USUAL CARE): Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.

After completion of study, patients are followed up at 1 month.

Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
Being tested: Best Practice, Educational Intervention, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Receive enhanced usual care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive Y-AMBIENT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT05243056
Study group	Role	What they receive
Arm I (Y-AMBIENT)	Experimental	Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (enhanced usual care)	Active comparator	Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of screen-eligible patients enrolled by consent
Descriptive statistics will be used to compute the proportion of screen-eligible patients enrolled by consent. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.
Measured: Up to 2 years
Proportion of patients that complete all (seven) study contacts of intervention
Descriptive statistics will be used to compute proportion of patients that complete all (seven) study contacts of the intervention. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.
Measured: Up to 2 years
Acceptability/Relevance of Intervention Sessions
Will use qualitative interview to assess participants' perceptions of its acceptability/relevance of each of the six study contacts, using a Likert scale 0 to 10 with 0 being not at all satisfied/useful and 10 being completely satisfied/useful and an open ended question to understand why each score was provided. A composite score will be determined, where higher scores equate to higher acceptability/relevance. Descriptive statistics will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. Qualitative responses will be analyzed for content.
Measured: Up to 2 years
Participation in aspects of protocol
Will use qualitative interview to assess participants' engagement by review of task completion to participate in aspects of the protocol (as an indicator of participant burden). There are a total of six sessions to complete and seven videos to review. Descriptive statistics will be used to compute the proportion of participant self-reported effectiveness of each intervention via the logs. Completion of tasks indicates greater willingness to participate.
Measured: Up to 2 years
Use of proposed self-management strategies and perceived effectiveness
Will use qualitative interview to assess participants' engagement by review of use of proposed self-management strategies and their perceived effect on quality of life concerns using a Likert scale 0 to 10 with 0 being not at all effective and 10 being most effective. Descriptive statistics will be used to compute the proportion of participant self-reported effectiveness of each intervention via the logs. Qualitative responses will be analyzed for content.
Measured: Up to 2 years
Medical Outcomes Survey Short-Form (SF-36)
The SF-36 is a well-established measure of health status in cancer survivors. SF-36 includes one multi-item scale assessing eight health concepts: limitations in physical activity, social activity, role activity, bodily pain, psychological distress, limitations in social activity due to emotional distress, vitality, and general health perceptions. The scale ranges from 0-100. Higher scores indicate better functioning.
Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.
Measured: Baseline up to 1 month post-intervention
PROMIS Global Health10
The PROMIS Global Health 10 is a well-established measure of health status in cancer survivors. It assesses health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Higher scores indicate better functioning.
Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.
Measured: Baseline up to 1 month post-intervention
(Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)
The FACIT-SP-12 is the most widely used measure of spiritual well-being among those with cancer. Its subscales measure faith, meaning, and peace. Higher scores reflect higher well-being.
Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.
Measured: Baseline up to 1 month post-intervention
MOS Modified Social Support Survey
MOS assesses dimensions of social support with four functional support scales: emotional/informational, tangible, affectionate, and positive social interaction. The scale ranges from 0-100. Higher scores indicate greater social support.
Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.
Measured: Baseline up to 1 month post-intervention
COmprehensive Score for Financial Toxicity [COST]-Functional Assessment of Chronic Illness Therapy [FACIT]
COST-FACIT is a measure of financial toxicity and/or concerns related to cost of cancer care. Lower COST scores indicate higher financial toxicity.
Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.
Measured: Baseline up to 1 month post-intervention
PROMIS Applied Cognition - General Concerns short form (8- item)
This instrument measures working memory, speed of processing, and executive control of cognitive functioning. Higher scores reflect higher perceived cognitive functionality.
Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.
Measured: Baseline up to 1 month post-intervention
Perceived Stress
This instrument measures the perception of stress.
The PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. This study will be using a short scale version of the scale, which uses four of the questions (2,4,5, and 10) of the questionnaire.
Measured: Baseline up to 1 month post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202230 Dec 2025

First posted16 Feb 2022
Study start1 Jun 2022
Primary completion30 Dec 2025
Study completion30 Dec 2025

Why it stopped: Recruitment was terminated due to slow enrollment and ending of the funded grant.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05243056
Sponsor's protocol ID: IRB-300012132
Other IDs: K08CA245208, NCI-2021-02286
Status last verified: May 2026
First submitted: 10 Nov 2021
Last updated: 6 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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