N/A
N=236
Telephone Support for Metastatic Breast Cancer Patients
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03998618 ↗Enrolled (actual)
236
Serious AEs
7.6%
Results posted
Oct 2024
Primary outcome: Primary: Fatigue Interference Subscale of Fatigue Symptom Inventory — 2.96; 3.66; 3.24; 3.43 units on a scale — p=.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acceptance and Commitment Therapy (Behavioral); Education/Support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Interference Subscale of Fatigue Symptom Inventory |
2.96; 3.66; 3.24; 3.43; 3.08; 3.64 | .018 sig |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment |
55.28; 56.26; 54.27; 54.62; 54.05; 54.78 | .037 sig |
| SECONDARY PROMIS Ability to Participate in Social Roles and Activities |
46.75; 46.66; 47.49; 46.75; 46.81; 46.10 | .355 |
| SECONDARY Functional Assessment of Cancer Therapy-General |
17.73; 16.99; 17.34; 16.90; 17.18; 16.54 | .167 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03998618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.