Clinical trial · Interventional
Telephone Support for Metastatic Breast Cancer Patients
- 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)
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in metastatic breast cancer (MBC) cancer patients. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. A demonstration of ACT's efficacy will lead to dissemination of the intervention and ultimately fulfill an unmet need in the comprehensive care of MBC patients.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | — | UNRESOLVED |
| Education/Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acceptance and Commitment Therapy
- description
- Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
- interventionNames
- Behavioral: Acceptance and Commitment Therapy
- type
- ACTIVE_COMPARATOR
- label
- Education/Support
- description
- Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
- interventionNames
- Behavioral: Education/Support
Primary outcomes (1)
- measure
- Fatigue Interference Subscale of Fatigue Symptom Inventory
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is at least 3 weeks post-diagnosis of stage IV breast cancer and is receiving care at the Indiana University (IU) Simon Cancer Center, Eskenazi Health, IU Health North, IU Health Bloomington, IU Health Ball Memorial, IU Health Portland, IU Health Morgan, IU Health New Castle, IU Health Central-Fishers, another IU Health hospital or clinic, Community Health Network, or the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. * Patient is at least 18 years of age. * Patient has adequate English fluency for completion of data collection. * Patient has moderate to severe fatigue interference with functioning Exclusion Criteria: * Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation. * Patient reports being able to do little activity on a functional status measure. * Patient is receiving hospice care at screening. * Patient does not have working phone service. * Patient has hearing impairment that precludes participation. * Male sex
References
Publications (1)
- DERIVEDMosher CE, Lee S, Addington EL, Park S, Lewson AB, Snyder S, Hirsh AT, Bricker JB, Miller KD, Ballinger TJ, Schneider BP, Storniolo AM, Newton EV, Champion VL, Johns SA. Randomized Controlled Trial of Acceptance and Commitment Therapy for Fatigue Interference With Functioning in Metastatic Breast Cancer. J Clin Oncol. 2025 Feb 20;43(6):662-671. doi: 10.1200/JCO.24.00965. Epub 2024 Oct 25. PMID 39454125