Effect of a Mentor-based, Supportive-expressive Program on Survival in Metastatic Breast Cancer

Metastatic Breastcancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03026374
• Other study ID #: ZYZC20160901
• Secondary ID: ZYZC20160901
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2017
• Last updated: January 17, 2017
• Start date: June 2017

Study information

• Verified date: January 2017
• Source: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide. Additionally, 30% of early breast cancer turns metastatic, which is often incurable. Different from women with early breast cancer, women with metastatic breast cancer(MBC)must receive lifelong treatment, experience higher levels of emotional/physical distress, and feel frequent uncertainty about their health/possible death. They are also challenged to manage distressing adverse effects induced by different adjuvant treatments and experience heavy self-care demands during the transition period from being a patient to being a survivor. Thus, specific interventions to help women with metastatic breast cancer to recover from this traumatic event have been designed, and one of these is supportive-expressive group therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT on survival is inconsistent. Initial studies examining SEGT have reported a mean survival advantage of 18 months, however, these findings could not later be replicated.Yet, no study has reported a survival disadvantage for those given SEGT. In addition, we found no published articles on the application of SEGT among women with MBC in China. Owing to this dearth of previous research, it is unclear whether this therapy would exhibit positive effects within Chinese culture. Thus, we developed a "Be Resilient to Breast Cancer"(BRBC) program that is culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is designed to increase resilience(defined as the capacity to bounce back after encountering a traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and eventually prolong longevity. To better adapt to Chinese culture, we added education hosted by professional staff (e.g., clinical psychologists, dietician, Chinese medicine practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain, fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control, meditation, etc.),and to help patients gain a sense of control in their life. Second, trained mentors, who were breast cancer survivors themselves, were added to the group discussion to create non-hierarchical, reciprocal relationships through the sharing of experiences with those facing similar challenges. These mentors also provided women with first-hand information about treatment and offered suggestions to combat barriers to recovery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• (1) women with confirmed breast cancer, stratified by stage(II,III, and IV),(2) metastases outside of the breast and ipsilateral axilla, and (3) fluent in oral Mandarin or Cantonese.

Exclusion Criteria:

• (1) central nervous system metastases, (2) a history of repeated suicidal behavior, (3) active psychosis or severe character disorder, (4) a life expectancy of less than 3 months(as assessed by primary oncologist), and/or (5)declined to participate in the program

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breastcancer

Intervention

Behavioral:
• Be Resilient to Breast Cancer
This is a supportive-expressive group therapy.

Locations

Country	Name	City	State
China	Zeng Jie Ye	Guangzhou Shi	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3- and 5-year survival		3 and 5 years since intervention
Secondary	allostatic load index(ALI)	ALI was a composite index measured by 14 indicators from different physiological systems, including body mass index (BMI), waist-hip ratio (WHR), resting pulse(RP), the standard deviation of R-R intervals (SDRR, heartbeat to heartbeat), resting systolicand diastolic blood pressure(SBP and DBP, respectively), white blood cell count (WBC), red blood cell count (RBC), hemoglobin, serotonin, hormone cortisol(HC), C-reactive protein(CRP), interleukin-6 (IL-6) and Cluster of Differentiation 4/ Cluster of Differentiation 8(CD4+/CD8+). These indicators were selected to evaluate the functions of sympathetic nervous system (SNS), parasympathetic nervous system (PNS), hypothalamic pituitary adrenal (HPA), cardiovascular, inflammation, and immunization. If a physical indicator was diagnosed as abnormal (i.e., RP of 107; normal range 60-100), patient would receive 1 point. Higher point totals indicated higher allostatic load. ALI range was from 0(extremely low) to 14(extremely high).	baseline, 2 months, 6 months, and 12 months since intervention
Secondary	Resilience	Resilience was measured by the 10 item Conner-Davison Resilience Scale (CD-RISC-10), which is a self-administered questionnaire based on a 5-point scale, with higher scores reflecting more resilience.	baseline, 2 months, 6 months, and 12 months since intervention
Secondary	Quality of Life	QoL was measured by QLQ-C30 core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), which contains 30 items pertaining to different patient QoL aspects.	baseline, 2 months, 6 months, and 12 months since intervention
Secondary	Anxiety	Anxiety was measured by the Chinese version of Hospital Anxiety and Depression Scale (HADS), which contains 7 items for anxiety and 7 items for depression, respectively, scored on a 5-point scale. Higher scores indicate higher levels of anxiety.	baseline, 2 months, 6 months, and 12 months since intervention
Secondary	Depression	Depression was measured by the Chinese version of Hospital Anxiety and Depression Scale (HADS), which contains 7 items for anxiety and 7 items for depression, respectively, scored on a 5-point scale. Higher scores indicate higher levels of depression.	baseline, 2 months, 6 months, and 12 months since intervention