Clinical trial · Interventional
Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors
NCT05452681CI-TRIAL-00110699terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The recruitment for the study slowed and funding for the study has completed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (21)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIC Breast Cancer AJCC v8 | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Intervention | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Y-AMBIENT
- description
- 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.
- interventionNames
- Other: Educational Intervention
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Attention Control
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 44 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder
References
Publications (0)
Data not yet available
No reference posted for this study.