This study looks to develop an online program using ideas from acceptance and commitment therapy and adapting them for women living with breast cancer that has spread to different parts of the body (metastatic). Women with metastatic breast cancer face unique challenges, including managing symptoms such as pain and discomfort, changes in their professional and personal lives, complex feelings, and communication with multiple healthcare providers. Despite these challenges, cancer survivors often talk about the importance of finding meaning in their cancer experience, and in their lives in general. Acceptance and commitment therapy helps individuals to create “a life worth living” by promoting meaning and purpose through coping strategies, mindfulness, and activities aligned with their personal values. Acceptance and commitment therapy may help improve the quality of life of patients with breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04374825.
PRIMARY OBJECTIVE:
I. To assess the impact of the adapted acceptance and commitment therapy (ACT) intervention as compared to a cognitive behavioral stress management (CBSM) intervention and to a usual care control on health-related quality of life in patients with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To assess the impact of the adapted ACT intervention as compared to a standard CBSM intervention and to a usual care control on wellbeing (physical, emotional, social, and function) and disease symptom bother in patients with metastatic breast cancer.
II. To assess the impact of the adapted ACT intervention as compared to a CBSM intervention and to a usual care control on meaning and purpose in life and positive affect in patients with metastatic breast cancer.
III. To assess the impact of the adapted ACT intervention as compared to a CBSM intervention and to a usual care control on social support (emotional, informational) in patients with metastatic breast cancer.
IV. To assess the impact of the adapted ACT intervention as compared to a CBSM intervention and to a usual care control on self-efficacy (perceived confidence using coping strategies, relaxation and assertiveness techniques) in patients with metastatic breast cancer.
V. To assess the impact of the adapted ACT intervention as compared to a CBSM intervention and to a usual care control on acceptance (also known as psychological flexibility) in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive standard of care.
ARM II: Patients participate in 90 minute group sessions over 1.5 hours once a week (QW) for 8 weeks discussing key concepts of CBSM and learning relaxation techniques.
ARM III: Patients participate in 90 minute group sessions over 1.5 hours QW for 8 weeks discussing key concepts of ACT and learning mindfulness techniques.
After completion of study, patients are followed up at 1 month.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorPatricia I. Moreno
