Clinical trial · Interventional
A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
NCT06831838CI-TRIAL-00120551recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy based Pain Management Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Subjects randomized to the treatment group will participate in a multicomponent pain treatment program in addition to standard of care treatment.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy based Pain Management Program
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Subjects randomized to the control group will continue to receive standard of care treatment. At the end of the study, the control group participants will be offered the multicomponent pain treatment program.
Primary outcomes (2)
- measure
- Adherence to Aromatase Inhibitors (AIs)
- timeFrame
- Baseline, 3 months, 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old * ECOG ≤ 2 * Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life Exclusion Criteria: • Less than 18 years of age. \- Stage 4 HR+ breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.