Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
character strengths-based intervention
early memories
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring self-esteem, quality of life, depression
Eligibility Criteria
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.
Sites / Locations
- Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
- The Second Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
The intervention group
The control group
Arm Description
Character strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session.
Early memories for placebo control, 3 sessions every week for three weeks. 30 minutes each session.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04219267
First Posted
December 20, 2019
Last Updated
January 25, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04219267
Brief Title
Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients
Official Title
Effectiveness of Character Strengths-based Intervention in Enhancing Self-esteem, Quality of Life and Alleviating Depression Among Breast Cancer Patients: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
self-esteem, quality of life, depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The intervention group
Arm Type
Experimental
Arm Description
Character strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session.
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
Early memories for placebo control, 3 sessions every week for three weeks. 30 minutes each session.
Intervention Type
Behavioral
Intervention Name(s)
character strengths-based intervention
Other Intervention Name(s)
strengths-based intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
early memories
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline self-esteem at 2 months,The Rosenberg Self-esteem Scale (RSES)
Description
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.
Time Frame
baseline, 1 and 2 months
Secondary Outcome Measure Information:
Title
Change from baseline quality of life at 2 months, The Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4)
Description
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.
Time Frame
baseline, 1 and 2 months
Title
Change from baseline depression at 2 months, The Patient Health Questionnaire 9 (PHQ-9)
Description
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.
Time Frame
baseline, 1 and 2 months
Title
Change from baseline character strengths at 2 months, The Chinese Virtues Questionnaire (CVQ)
Description
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.
Time Frame
baseline, 1 and 2 months
Other Pre-specified Outcome Measures:
Title
Participants' satisfaction with care
Description
Participants' satisfaction with care during the study will be assessed on a five-item checklist developed for this study. Questions such as "Overall, how satisfied are you with the care so far?" will be rated on a five-point Likert scale, ranging from 1 "not at all" to 5 "very much". For each item, higher scores indicate greater satisfaction.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Chan, PhD
Organizational Affiliation
The Chinese University of Hongkong
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ka Ming Chow, PhD
Organizational Affiliation
The Chinese University of Hongkong
Official's Role
Study Director
Facility Information:
Facility Name
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients
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