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Metastatic BreastcancerNCT03026374

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

A study testing Be Resilient to Breast Cancer in people with Metastatic Breastcancer, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Metastatic Breastcancer
What is being tested?
Be Resilient to Breast Cancer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteChina
Study dates
Jun 2017to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zeng Jie Ye

    Guangzhou, Guangdong, 510006

    Zeng Jie Ye, 13427583750, 1047052548@qq.com

Other trials in China

About this study

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.

Being tested
Be Resilient to Breast Cancer
Keywords
psychosocial support, resilience, metastatic breast cancer, survival, Quality of Life
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Be Resilient to Breast CancerBehavioural

    Also called BRBC

    This is a supportive-expressive group therapy.

Study groups in NCT03026374
Study groupRoleWhat they receive
intervention groupExperimentalThe 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.
Receives: Behavioral: Be Resilient to Breast Cancer
control groupNo interventionpatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3- and 5-year survival

    Measured: 3 and 5 years since intervention

Secondary outcomes (5)
  1. 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).

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study startJun 2017
  3. Primary completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026374
Sponsor's protocol ID
ZYZC20160901
Other IDs
ZYZC20160901
Status last verified
Jan 2017
First submitted
14 Jan 2017
Last updated
20 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40226738
  • 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.

    PubMed 40226657

Questions about this trial

What is this clinical trial studying?

A study testing Be Resilient to Breast Cancer in people with Metastatic Breastcancer, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3- and 5-year survival (time frame: 3 and 5 years since intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026374, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.

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