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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Breastcancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention group

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.

Group Type EXPERIMENTAL

Be Resilient to Breast Cancer

Intervention Type BEHAVIORAL

This is a supportive-expressive group therapy.

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Be Resilient to Breast Cancer

This is a supportive-expressive group therapy.

Intervention Type BEHAVIORAL

Other Intervention Names

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BRBC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No