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NCT Number: NCT04219267

Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University), Zhengzhou, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

character strengths-based intervention

Behavioral

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.

Other names: strengths-based intervention

early memories

Behavioral

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 outcomes

  1. Change from baseline self-esteem at 2 months,The Rosenberg Self-esteem Scale (RSES)

    Time frame: baseline, 1 and 2 months

    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 outcomes

  1. Change from baseline quality of life at 2 months, The Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B, version 4)

    Time frame: baseline, 1 and 2 months

    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.

  2. Change from baseline depression at 2 months, The Patient Health Questionnaire 9 (PHQ-9)

    Time frame: baseline, 1 and 2 months

    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.

  3. Change from baseline character strengths at 2 months, The Chinese Virtues Questionnaire (CVQ)

    Time frame: baseline, 1 and 2 months

    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.

Other outcomes

  1. Participants' satisfaction with care

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2020
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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