Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients

Study Overview
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Brief Summary
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The research design is a randomized control trial to evaluate the effectiveness of character strengths-based intervention in enhancing self-esteem, quality of life and alleviating depression in breast cancer patients. The type of intervention is psychological intervention. Participants in the intervention group will receive character strengths-based intervention. Participants in the control group will receive placebo control care.

Detailed Description
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The character strengths-based intervention may could enhance self-esteem, quality of life and alleviate depression, but the placebo control care did not do so. Strengths use is indeed associated with elevated levels of life satisfaction and quality of life. It is positively related to self-esteem and leads to greater self-esteem over time. Moreover, strengths use could help decrease depression in the patients, and has beneficial effect on quality of life. There is a model that examined the mechanism of how strengths use related to enhanced self-esteem, happiness and life satisfaction. Individuals who use their strengths and experience greater levels of life satisfaction is mediated by self-esteem and depression. Preliminary evidence suggested that character strengths-based intervention has positive impact on psychological well-being include improving self-esteem among women with breast cancer in Spain. However, there is a worldwide paucity of rigorous trials that have evaluated the effectiveness of character strengths-based interventions for breast cancer patients.

Official Title
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Effectiveness of Character Strengths-based Intervention in Enhancing Self-esteem, Quality of Life and Alleviating Depression Among Breast Cancer Patients: A Randomized Controlled Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: character strengths-based intervention
* Behavioral: early memories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a confirmed diagnosis of breast cancer; aged above 18 years old; native Chinese and proficient in oral mandarin communication; agree to participate in the study and offer a written informed consent regarding their voluntary; are able to comprehend and complete the questionnaires independently. Exclusion Criteria: suffering from other or multiple life-threatening diseases; psychosis (for example, delusional disorder, schizophrenia); having participated in any type of group or individual psychological intervention in the past half year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>Character strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session. | Behavioral: character strengths-based intervention<br>* Character strengths-based intervention (CSI) is one kind of positive psychology interventions. It specifically focuses on character strengths, related activities and exercises assisting individuals to reconnect with their characters and promote self-conceptualization. The researcher will develop an education module on CSI based on the previous literatures conducted in China and other countries. Before the RCT, this module will be adapted to Chinese participants. During the intervention, participants in the intervention group will be offered the educational module to learn about strengths, comments around the definition of character strengths and examples of specific strengths.<br>* Other names: strengths-based intervention;|
| Placebo Comparator: The control group<br>Early memories for placebo control, 3 sessions every week for three weeks. 30 minutes each session. | Behavioral: early memories<br>* In early memories, participants will be instructed to write down something from their early memories every day. The memories could be the things happened several days or many years before the writing day. The memories could be participant' travel experiences or food for a day. There are no strict restrictions on the timing or content of these early events.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline self-esteem at 2 months,The Rosenberg Self-esteem Scale (RSES) | The RSES measures the overall sense of being capable and feeling worthwhile and competent. The Chinese version of RSES will be used in this study. The questionnaire consists of 10 items measured on a five-point Likert scale, higher scores indicating higher self-esteem. | baseline, 1 and 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline quality of life at 2 months, The Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4) | The Chinese version of FACT-B has undergone cultural adaptation and been used among breast cancer patients in China for many years. The scale consists of 37 items, which are clustered into five domains of quality of life: physical, emotional, social / family, functional well-being and additional concerns of breast cancers, scoring from 0 to 4. | baseline, 1 and 2 months | 
| Change from baseline depression at 2 months, The Patient Health Questionnaire 9 (PHQ-9) | The Patient Health Questionnaire 9 (PHQ-9) will be used to assess the symptoms of depression by reporting the frequency and the degree of emotional distress in the past two weeks. | baseline, 1 and 2 months | 
| Change from baseline character strengths at 2 months, The Chinese Virtues Questionnaire (CVQ) | The Chinese Virtues Questionnaire (CVQ) will be used to assess the character strengths of participants. It is the Chinese version of Values in Action Inventory of Strengths (VIA-IS). The CVQ has 96 items. Each question uses five-point Likert scale from very unlike me to very much like me. The higher the score of a character strength, the more prominent the strength of the subject. This scale was developed to examine a person's signature strengths, and has been widely used in adults from various countries. | baseline, 1 and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-esteem, quality of life, depression