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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Metastatic Breastcancer
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3- and 5-year survival
Measured: 3 and 5 years since intervention
Secondary outcomes (5)
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
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
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
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
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.
- First posted20 Jan 2017 (estimated)
- Study startJun 2017
- Primary completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic BreastcancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Jie Ye, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
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 40226738Liang 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mentor-based, Supportive-expressive Program on Survival in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03026374
- Acronym / sponsor ID
- ZYZC20160901
- Conditions
- Metastatic Breastcancer
- Keywords
- psychosocial support, resilience, metastatic breast cancer, survival, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2017
- Primary completion
- Jun 2022 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Be Resilient to Breast CancerThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Be Resilient to Breast CancerAlso: BRBCThis is a supportive-expressive group therapy. | Behavioural | intervention group |
Primary outcome
3- and 5-year survival
Time frame: 3 and 5 years since intervention
5 secondary outcomes
allostatic load index(ALI)
Time frame: baseline, 2 months, 6 months, and 12 months since intervention
Resilience
Time frame: baseline, 2 months, 6 months, and 12 months since intervention
Quality of Life
Time frame: baseline, 2 months, 6 months, and 12 months since intervention
Anxiety
Time frame: baseline, 2 months, 6 months, and 12 months since intervention
Depression
Time frame: baseline, 2 months, 6 months, and 12 months since intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Derived from this study: PubMed 40226738Liang 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.
- Derived from this study: PubMed 40226657Liang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Breastcancer
Not yet recruiting
Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
Metastatic Breast Cancer, Metastatic Breast Cancer (MBC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.