Breast CancerNCT05452681
Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors
A study testing Educational Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Breast Cancer and Anatomic Stage I Breast Cancer AJCC v8, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Breast Cancer, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Educational Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 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
- Have completed treatment with chemotherapy and/or radiation for stage I-III breast cancer prior to 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
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
Primary Objectives
- Evaluate feasibility and acceptability of Y-AMBIENT and an attention control among young African American breast cancer survivors.
II. Explore the degree to which the Y-AMBIENT vs. attention control 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 (ATTENTION CONTROL): 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.
After completion of study, patients are followed up at 1 month.
- Conditions
- Breast Cancer, 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
- Being tested
- Educational Intervention, Quality-of-Life Assessment, Questionnaire Administration, Control Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Control InterventionOther
Also called Attention control intervention, Control Intervention, Attention
Receive cookbook and socialization calls
| Study group | Role | What they receive |
|---|---|---|
| Y-AMBIENT | Experimental | Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. All themed education and follow-up sessions are conducted according to the respective Y-AMBIENT session outlines and audio-recorded. Session 1, titled "My Self, My Soul," covers topics related to spiritual growth and finding meaning in illness. Session 2, titled "My Body," covers topics related to breast changes, aches/pains, fatigue, and weight changes. Session 3, titled "My Mind and My Relationships," covers topics related to anxiety, fear, and relationships with others. The sessions will take approximately one hour, with follow-ups lasting about 20 minutes. Participants will receive both printed and electronic PDF versions of written materials, in addition to video links, to reinforce content delivered during Sessions. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Attention Control | Active comparator | The control condition will consist of receiving a culturally-targeted cookbook applied by an adapted "Food for Thought" cookbook, a guide to grocery shopping smart, and telephone socialization calls. We opted to use the cookbook and guide as conversation pieces given cultural practices associated with food and avert financial constraints with shopping tips. During three, one-hour socialization calls, we will use scripted questions to encourage discussion about the participant, cookbook and guide, and obtain information about survivorship concerns without providing coaching. The follow-up calls will last about 20 minutes. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Control Intervention |
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 (five) study contacts of intervention
Descriptive statistics will be used to compute proportion of patients that complete all (five) 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Why it stopped: The recruitment for the study slowed and funding for the study has completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- 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
- NCT05452681
- Sponsor's protocol ID
- IRB-300012133
- Status last verified
- May 2026
- First submitted
- 6 Jul 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No