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Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04219267
Recruitment Status : Completed
First Posted : January 7, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Tingting YAN, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: character strengths-based intervention Behavioral: early memories Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 4, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: The intervention group
Character strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session.
 Behavioral: character strengths-based intervention

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 Name: strengths-based intervention
Placebo Comparator: The control group
Early memories for placebo control, 3 sessions every week for three weeks. 30 minutes each session.
 Behavioral: early memories
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219267


Locations
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China, Henan
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Study Director: Carmen Chan, PhD The Chinese University of Hongkong
Study Director: Ka Ming Chow, PhD The Chinese University of Hongkong
More Information
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Publications:

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Responsible Party: Tingting YAN, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04219267    
Other Study ID Numbers: 2019.429
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tingting YAN, Chinese University of Hong Kong:
self-esteem
quality of life
depression
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases