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.
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
- Are there results?
- None posted in the registry
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
About this study
Official title: Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment
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, and videos. The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Timiya Nolan, University of Alabama at Birmingham
- Investigators
- Timiya Nolan, PhD, Principal investigator, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment
- ClinicalTrials.gov ID
- NCT05243056
- Acronym / sponsor ID
- IRB-300012132
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was terminated due to slow enrollment and ending of the funded grant.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, and videos. The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Y-AMBIENT) | Experimental | Other: Educational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive enhanced usual care | Other | Arm II (enhanced usual care) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive Y-AMBIENT | Other | Arm I (Y-AMBIENT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (Y-AMBIENT), Arm II (enhanced usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Y-AMBIENT), Arm II (enhanced usual care) |
Primary outcome
Proportion of screen-eligible patients enrolled by consent
Time frame: Up to 2 years
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.
Proportion of patients that complete all (seven) study contacts of intervention
Time frame: Up to 2 years
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.
Acceptability/Relevance of Intervention Sessions
Time frame: Up to 2 years
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.
Participation in aspects of protocol
Time frame: Up to 2 years
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.
Use of proposed self-management strategies and perceived effectiveness
Time frame: Up to 2 years
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.
Medical Outcomes Survey Short-Form (SF-36)
Time frame: Baseline up to 1 month post-intervention
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.
PROMIS Global Health10
Time frame: Baseline up to 1 month post-intervention
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.
(Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)
Time frame: Baseline up to 1 month post-intervention
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.
MOS Modified Social Support Survey
Time frame: Baseline up to 1 month post-intervention
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.
COmprehensive Score for Financial Toxicity [COST]-Functional Assessment of Chronic Illness Therapy [FACIT]
Time frame: Baseline up to 1 month post-intervention
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.
PROMIS Applied Cognition - General Concerns short form (8- item)
Time frame: Baseline up to 1 month post-intervention
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.
Perceived Stress
Time frame: Baseline up to 1 month post-intervention
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.
Results and safety
The study was stopped early (reason given: Recruitment was terminated due to slow enrollment and ending of the funded grant.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timiya Nolan, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was terminated due to slow enrollment and ending of the funded grant.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of screen-eligible patients enrolled by consent (time frame: Up to 2 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.