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

NCT03026374 | Unknown DMC

• 1 other identifier: ZYZC20160901
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breastcancer

Keywords

psychosocial support; resilience; metastatic breast cancer; survival; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 3- and 5-year survival

  3 and 5 years since intervention

Secondary Outcomes (5)

• allostatic load index(ALI)

  baseline, 2 months, 6 months, and 12 months since intervention

• Resilience

  baseline, 2 months, 6 months, and 12 months since intervention

• Quality of Life

  baseline, 2 months, 6 months, and 12 months since intervention

• Anxiety

  baseline, 2 months, 6 months, and 12 months since intervention

• Depression

  baseline, 2 months, 6 months, and 12 months since intervention

Study Arms (2)

intervention group

EXPERIMENTAL

The BRBC program consists of education and group discussion, and lasted for 12 months. Women in IG attended weekly meetings lasting for 120 minutes. Education took approximately 45 minute. Qualified professionals from various disciplines were invited to provide lessons to ensure the quality of the educational sessions. The group discussion followed the presentation and began with mentors sharing their experience with the topic, followed by participant discussions regarding life changes since diagnosis (e.g., physical, emotional, social, spiritual). Each group consisted of 7-9 patients and 3 leaders (2 mentors and 1 facilitator, including a clinical psychologist, nurse clinician, or social worker). The time of group discussion varied from 45-75 minutes. This was intended to foster support among group members,both in and out of sessions.

Behavioral: Be Resilient to Breast Cancer

control group

NO INTERVENTION

patients from both groups were provided medical, social, or psychological care if necessary, as assessed by primary oncologists. Additionally, all patients received an educational brochure about breast cancer every 1 to 2 months, and relaxation therapy was provided to both groups to prevent demoralization from random assignment.

Interventions

Be Resilient to Breast Cancer BEHAVIORAL

This is a supportive-expressive group therapy.

Also known as: BRBC

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Zeng Jie Ye

Guangzhou, Guangdong, 510006, China

Location

Related Publications (2)

• Liang MZ, Chen P, Tang Y, Liang YY, Li SH, Hu GY, Sun Z, Yu YL, Molassiotis A, Knobf MT, Ye ZJ. Associations Between Brain Structural Connectivity and 1-Year Demoralization in Breast Cancer: A Longitudinal Diffusion Tensor Imaging Study. Depress Anxiety. 2024 Sep 26;2024:5595912. doi: 10.1155/2024/5595912. eCollection 2024.

  PMID: 40226738 DERIVED

• Liang MZ, Zhou J, Chen P, Song YL, Li SH, Liang YY, Hu GY, Hu Q, Sun Z, Yu YL, Molassiotis A, Knobf MT, Ye ZJ. A Longitudinal Correlational Study of Psychological Resilience, Depression Disorder, and Brain Functional-Structural Hybrid Connectome in Breast Cancer. Depress Anxiety. 2024 Nov 18;2024:9294268. doi: 10.1155/2024/9294268. eCollection 2024.

  PMID: 40226657 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 14, 2017
• First Posted: January 20, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2022
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

CN (1)