Breast CancerNCT04219267

Effectiveness of Character Strengths-based Intervention Among Breast Cancer Patients

A study testing character strengths-based intervention and early memories in people with Breast Cancer, run by Chinese University of Hong Kong at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: character strengths-based intervention and early memories
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 2 sitesChina
Study dates: 4 May 2020to 20 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

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

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Breast Cancer
Being tested: character strengths-based intervention, early memories
Keywords: self-esteem, quality of life, depression
Medical subject headings: Breast Neoplasms, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

character strengths-based interventionBehavioural
Also called 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.
early memoriesBehavioural
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.

Study groups in NCT04219267
Study group	Role	What they receive
The intervention group	Experimental	Character strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session. Receives: 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. Receives: Behavioral: early memories

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: baseline, 1 and 2 months
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.
Measured: baseline, 1 and 2 months
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.
Measured: baseline, 1 and 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 202020 Dec 2020

First posted7 Jan 2020
Study start4 May 2020
Primary completion30 Nov 2020
Study completion20 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04219267
Sponsor's protocol ID: 2019.429
Status last verified: Jan 2021
First submitted: 20 Dec 2019
Last updated: 27 Jan 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Al-Abri R, Al-Balushi A. Patient satisfaction survey as a tool towards quality improvement. Oman Med J. 2014 Jan;29(1):3-7. doi: 10.5001/omj.2014.02.
PubMed 24501659
Andrewes HE, Walker V, O'Neill B. Exploring the use of positive psychology interventions in brain injury survivors with challenging behaviour. Brain Inj. 2014;28(7):965-71. doi: 10.3109/02699052.2014.888764. Epub 2014 Mar 21.
PubMed 24826958
Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536
Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.
PubMed 15695497
Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.
PubMed 15162149
Carver CS, Smith RG, Antoni MH, Petronis VM, Weiss S, Derhagopian RP. Optimistic personality and psychosocial well-being during treatment predict psychosocial well-being among long-term survivors of breast cancer. Health Psychol. 2005 Sep;24(5):508-16. doi: 10.1037/0278-6133.24.5.508.
PubMed 16162045
Victoria Cerezo M, Ortiz-Tallo M, Cardenal V, De La Torre-Luque A. Positive psychology group intervention for breast cancer patients: a randomised trial. Psychol Rep. 2014 Aug;115(1):44-64. doi: 10.2466/15.20.PR0.115c17z7.
PubMed 25153949
Chen S, Chiu H, Xu B, Ma Y, Jin T, Wu M, Conwell Y. Reliability and validity of the PHQ-9 for screening late-life depression in Chinese primary care. Int J Geriatr Psychiatry. 2010 Nov;25(11):1127-33. doi: 10.1002/gps.2442.
PubMed 20029795
Cheung YB, Goh C, Thumboo J, Khoo KS, Wee J. Variability and sample size requirements of quality-of-life measures: a randomized study of three major questionnaires. J Clin Oncol. 2005 Aug 1;23(22):4936-44. doi: 10.1200/JCO.2005.07.141.
PubMed 16051946
Ell K, Sanchez K, Vourlekis B, Lee PJ, Dwight-Johnson M, Lagomasino I, Muderspach L, Russell C. Depression, correlates of depression, and receipt of depression care among low-income women with breast or gynecologic cancer. J Clin Oncol. 2005 May 1;23(13):3052-60. doi: 10.1200/JCO.2005.08.041.
PubMed 15860863
Curwood SE, DeGeer I, Hymmen P, Lehmann P. Using strength-based approaches to explore pretreatment change in men who abuse their partners. J Interpers Violence. 2011 Sep;26(13):2698-715. doi: 10.1177/0886260510388283. Epub 2010 Dec 13.
PubMed 21156680
den Heijer M, Seynaeve C, Vanheusden K, Duivenvoorden HJ, Vos J, Bartels CC, Menke-Pluymers MB, Tibben A. The contribution of self-esteem and self-concept in psychological distress in women at risk of hereditary breast cancer. Psychooncology. 2011 Nov;20(11):1170-5. doi: 10.1002/pon.1824. Epub 2010 Aug 4.
PubMed 20690113
Dura-Ferrandis E, Mandelblatt JS, Clapp J, Luta G, Faul L, Kimmick G, Cohen HJ, Yung RL, Hurria A. Personality, coping, and social support as predictors of long-term quality-of-life trajectories in older breast cancer survivors: CALGB protocol 369901 (Alliance). Psychooncology. 2017 Nov;26(11):1914-1921. doi: 10.1002/pon.4404. Epub 2017 Mar 9.
PubMed 28219113
Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23.
PubMed 21318011
Fann JR, Thomas-Rich AM, Katon WJ, Cowley D, Pepping M, McGregor BA, Gralow J. Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):112-26. doi: 10.1016/j.genhosppsych.2007.10.008.
PubMed 18291293

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04219267
Acronym / sponsor ID: 2019.429
Conditions: Breast Cancer
Keywords: self-esteem, quality of life, depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 4 May 2020 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 20 Dec 2020 (actual)
First posted: 7 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The intervention group	Experimental	Behavioral: character strengths-based interventionCharacter strengths-based intervention, 3 sessions every week for three weeks. 30 minutes each session.
The control group	Placebo comparator	Behavioral: early memoriesEarly memories for placebo control, 3 sessions every week for three weeks. 30 minutes each session.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
character strengths-based interventionAlso: strengths-based interventionCharacter 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.	Behavioural	The intervention group
early memoriesIn 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.	Behavioural	The control group

Primary outcome

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.

3 secondary outcomes

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
Change from baseline depression at 2 months, The Patient Health Questionnaire 9 (PHQ-9)
Time frame: baseline, 1 and 2 months
Change from baseline character strengths at 2 months, The Chinese Virtues Questionnaire (CVQ)
Time frame: baseline, 1 and 2 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Background: PubMed 24501659Al-Abri R, Al-Balushi A. Patient satisfaction survey as a tool towards quality improvement. Oman Med J. 2014 Jan;29(1):3-7. doi: 10.5001/omj.2014.02.
Background: PubMed 24826958Andrewes HE, Walker V, O'Neill B. Exploring the use of positive psychology interventions in brain injury survivors with challenging behaviour. Brain Inj. 2014;28(7):965-71. doi: 10.3109/02699052.2014.888764. Epub 2014 Mar 21.
Background: PubMed 9060536Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
Background: PubMed 15695497Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.
Background: PubMed 15162149Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.
Background: PubMed 16162045Carver CS, Smith RG, Antoni MH, Petronis VM, Weiss S, Derhagopian RP. Optimistic personality and psychosocial well-being during treatment predict psychosocial well-being among long-term survivors of breast cancer. Health Psychol. 2005 Sep;24(5):508-16. doi: 10.1037/0278-6133.24.5.508.
Background: PubMed 25153949Victoria Cerezo M, Ortiz-Tallo M, Cardenal V, De La Torre-Luque A. Positive psychology group intervention for breast cancer patients: a randomised trial. Psychol Rep. 2014 Aug;115(1):44-64. doi: 10.2466/15.20.PR0.115c17z7.
Background: PubMed 20029795Chen S, Chiu H, Xu B, Ma Y, Jin T, Wu M, Conwell Y. Reliability and validity of the PHQ-9 for screening late-life depression in Chinese primary care. Int J Geriatr Psychiatry. 2010 Nov;25(11):1127-33. doi: 10.1002/gps.2442.
Background: PubMed 16051946Cheung YB, Goh C, Thumboo J, Khoo KS, Wee J. Variability and sample size requirements of quality-of-life measures: a randomized study of three major questionnaires. J Clin Oncol. 2005 Aug 1;23(22):4936-44. doi: 10.1200/JCO.2005.07.141.
Background: PubMed 15860863Ell K, Sanchez K, Vourlekis B, Lee PJ, Dwight-Johnson M, Lagomasino I, Muderspach L, Russell C. Depression, correlates of depression, and receipt of depression care among low-income women with breast or gynecologic cancer. J Clin Oncol. 2005 May 1;23(13):3052-60. doi: 10.1200/JCO.2005.08.041.
Background: PubMed 21156680Curwood SE, DeGeer I, Hymmen P, Lehmann P. Using strength-based approaches to explore pretreatment change in men who abuse their partners. J Interpers Violence. 2011 Sep;26(13):2698-715. doi: 10.1177/0886260510388283. Epub 2010 Dec 13.
Background: PubMed 20690113den Heijer M, Seynaeve C, Vanheusden K, Duivenvoorden HJ, Vos J, Bartels CC, Menke-Pluymers MB, Tibben A. The contribution of self-esteem and self-concept in psychological distress in women at risk of hereditary breast cancer. Psychooncology. 2011 Nov;20(11):1170-5. doi: 10.1002/pon.1824. Epub 2010 Aug 4.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carmen Chan, PhD study director

The Chinese University of Hongkong

Ka Ming Chow, PhD study director

The Chinese University of Hongkong

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing character strengths-based intervention and early memories in people with Breast Cancer, run by Chinese University of Hong Kong at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline self-esteem at 2 months,The Rosenberg Self-esteem Scale (RSES) (time frame: baseline, 1 and 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04219267, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.