Clinical trial NCT04219267: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: self-esteem
quality of life
depression
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from baseline self-esteem at 2 months,The Rosenberg Self-esteem Scale (RSES)
timeFrame: baseline, 1 and 2 months
Secondary outcomes:
measure: Change from baseline quality of life at 2 months, The Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4)
timeFrame: baseline, 1 and 2 months
measure: Change from baseline depression at 2 months, The Patient Health Questionnaire 9 (PHQ-9)
timeFrame: baseline, 1 and 2 months
measure: Change from baseline character strengths at 2 months, The Chinese Virtues Questionnaire (CVQ)
timeFrame: baseline, 1 and 2 months
Other outcomes:
measure: Participants' satisfaction with care
timeFrame: 1 month
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The Chinese University of Hongkong
name: Carmen Chan, PhD
role: STUDY_DIRECTOR
affiliation: The Chinese University of Hongkong
name: Ka Ming Chow, PhD
role: STUDY_DIRECTOR
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