Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients

NCT04219267 | Completed

• 1 other identifier: 2019.429
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

self-esteem; quality of life; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  baseline, 1 and 2 months

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

  baseline, 1 and 2 months

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

  baseline, 1 and 2 months

Other Outcomes (1)

• Participants' satisfaction with care

  1 month

Study Arms (2)

The intervention group

EXPERIMENTAL

Character strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session.

Behavioral: character strengths-based intervention

The control group

PLACEBO COMPARATOR

Early memories for placebo control, 3 sessions every week for three weeks. 30 minutes each session.

Behavioral: early memories

Interventions

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.

Also known as: strengths-based intervention

The intervention group

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.

The control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

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

Zhengzhou, Henan, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

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• Yan T, Chow KM, Xiao J, Liang W, Nguyen KT, Choi KC, Chan CWH. Character Strengths-Based Intervention for Enhancing Self-esteem and Quality of Life and Alleviating Depression in Female Patients With Breast Cancer: A Randomized Controlled Trial. Cancer Nurs. 2025 Mar 24. doi: 10.1097/NCC.0000000000001486. Online ahead of print.

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• Yan T, Chan CWH, Chow KM, Xiao J, Li M. Development of an evidence-based, theory-driven, and culturally appropriate character strengths-based intervention for breast cancer patients, following the Medical Research Council Framework. Support Care Cancer. 2022 Dec 16;31(1):45. doi: 10.1007/s00520-022-07538-w.

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• Yan T, Chan CWH, Chow KM, Li M. Experiences and perception of character strengths among patients with breast cancer in China: a qualitative study. BMJ Open. 2022 Oct 28;12(10):e061994. doi: 10.1136/bmjopen-2022-061994.

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MeSH Terms

Conditions

Breast Neoplasms; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Carmen Chan, PhD

  The Chinese University of Hongkong

  STUDY DIRECTOR

• Ka Ming Chow, PhD

  The Chinese University of Hongkong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 7, 2020
• Study Start: May 4, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 20, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)