Prostate CancerNCT07015866
Creative Arts Therapy on Body Image, Self-esteem, Anxiety and Depression in Post-Treatment Prostate Cancer Patients
A study testing Guided therapy group and Creative arts therapy in people with Prostate Cancer and Creative Arts Therapy, run by The Hong Kong Polytechnic University.
Trial summary
The goal of this clinical study is to assess the feasibility of implementing a creative arts therapy intervention of drawing and painting in Hong Kong prostate cancer patients and preliminarily examine the effects of this intervention on prostate cancer patients' health outcomes via a two-armed randomized controlled… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Creative Arts Therapy
- What is being tested?
- Guided therapy group and Creative arts therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants diagnosed with localised prostate cancer, regardless of the stage and age 18 years or older;
- are not currently receiving active therapy, including chemotherapy, radiotherapy or surgical treatment, by the time of the study or completed treatment more than one year ago and are not on any active treatment;
- were being followed up by the urology team or Department of Surgery at the Chinese University of Hong Kong;
- are willing to participate in the study;
- are able to read Chinese and communicate in Cantonese;
- are physically able to attend and complete art therapy sessions;
- do not have significant comorbidities, including cerebrovascular accident, severe depression, or dementia that could affect their ability to participate in the study;
- signed an informed consent form.
Who cannot join
- Adult participants diagnosed with a mixed type of terminal cancer;
- are undergoing active therapy;
- have participated in other art therapy interventions;
- have physical issues preventing them from holding a pen;
- have a mental status and/or communication problem that might compromise their capacity to give informed consent;
- have significant comorbidities such as cerebrovascular accident, severe depression, or dementia, as determined by standardized screening tools a score of 20-27 on the Patient Health Questionnaire and score 25 or less on the Mini-Mental State Examination.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Janelle Yourk, PhD contact
About this study
Official title: Effects of Creative Arts Therapy on Body Image, Self-esteem, Anxiety and Depression in Men With Prostate Cancer After Active Treatment: A Feasibility Randomised Controlled Trial
The goal of this clinical study is to assess the feasibility of implementing a creative arts therapy intervention of drawing and painting in Hong Kong prostate cancer patients and preliminarily examine the effects of this intervention on prostate cancer patients' health outcomes via a two-armed randomized controlled trial. The two arms will be (i) the creative arts therapy intervention group and (ii) a active control group.
Participants will join five sessions. Sessions will start with a 10-15-minute rapport-building discussion and continue with a 60-minute intervention. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. Each session will follow a three-step process of psychodynamic model to ensure the optimal effect of the intervention. The interventions will be held at private room at hospital.
- Conditions
- Prostate Cancer, Creative Arts Therapy
- Being tested
- Guided therapy group, Creative arts therapy
- Keywords
- creative arts therapy, prostate cancer, body image, slef-esteem, anxiety, depression, active treatment
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided therapy groupOther
Participants will engage in guided group discussions over five sessions. Each session will include a guided discussion focusing on self-care topics such as sleep hygiene, dental hygiene, nutrition, and personal interests and hobbies. The first individual session, 'Sleep hygiene, will be used to educate the participants of the importance of sleep and strategies to improve sleep quality. The four other sessions will be group-based (with four participants per group), focusing on dental hygiene, nutrition, personal interests and hobbies and general well-being and reflection. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre.
Creative arts therapyOther
The intervention will be offered throughout five sessions. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion.
The first individual session, 'bridge drawing', will be used to introduce the creative arts therapy approach and to elaborate on this project. The four other sessions will be group-based (with four participants per group), providing a supportive and communal environment where participants can engage in creative expression alongside others who may have had similar experiences or challenges. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre that has been equipped and prepared for the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Creative arts therapy | Experimental | The intervention will be offered throughout five sessions. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. The first individual session, 'bridge drawing', will be used to introduce the creative arts therapy approach and to elaborate on this project. The four other sessions will be group-based (with four participants per group), providing a supportive and communal environment where participants can engage in creative expression alongside others who may have had similar experiences or challenges. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre that has been equipped and prepared for the intervention. Receives: Other: Creative arts therapy |
| Guided group discussions | Active comparator | Participants will engage in guided group discussions over five sessions. Each session will include a guided discussion focusing on self-care topics such as sleep hygiene, dental hygiene, nutrition, and personal interests and hobbies. The first individual session, 'Sleep hygiene, will be used to educate the participants of the importance of sleep and strategies to improve sleep quality. The four other sessions will be group-based (with four participants per group), focusing on dental hygiene, nutrition, personal interests and hobbies and general well-being and reflection. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre. Receives: Other: Guided therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body image
The Chinese version of the 10-item Body Image Scale (BIS) will be used to assess participants' perception of their body image, including influence, actions and cognition. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The BIS overall summary score ranges from 0 to 30, with a higher score indicating a poorer body image. The BIS was translated by school of nursing team at the Hong Kong Polytechnic University and has been utilised by our team
Measured: Baseline and 5 weeks
Self-esteem
The Chinese version of the Rosenberg Self-Esteem Scale (RSES) will be used to evaluate participants' general self-esteem. It consists of 10 items assessing positive and negative feelings about the self. Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The RSES overall score ranges from 10 to 40, with a higher score indicating high self-esteem. The RSES version as translated by school of nursing team at the Hong Kong Polytechnic University and has been utilised by our team.
Measured: Baseline and 5 weeks
Anxiety and depression
The Chinese version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess participants' anxiety and depression levels. The HADS consists of 14 items categorised into two subscales: anxiety and depression. Scores for each subscale are calculated and classified into one of three categories: normal cases (scores of 0-7), borderline cases (scores of 8-10) and cases (scores of 11-21). The Chinese version of the HADS has a strong intercorrelation between anxiety and depression in cancer patients (r = 0.83).
Measured: Baseline and 5 weeks
Retention rate
The number of patients who remain in the study divided by the number of patients randomised. The retention rate will be calculated for each arm at baseline and follow-ups.
Measured: Baseline, 5 weeks and 3 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, University of Derby
- Responsible party
- Principal investigator, ABU ODAH, Hammoda MM, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015866
- Sponsor's protocol ID
- 22231641
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creative Arts Therapy on Body Image, Self-esteem, Anxiety and Depression in Men With Prostate Cancer After Active Treatment: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07015866
- Acronym / sponsor ID
- 22231641
- Conditions
- Prostate Cancer, Creative Arts Therapy
- Keywords
- creative arts therapy, prostate cancer, body image, slef-esteem, anxiety, depression, active treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, University of Derby
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
The goal of this clinical study is to assess the feasibility of implementing a creative arts therapy intervention of drawing and painting in Hong Kong prostate cancer patients and preliminarily examine the effects of this intervention on prostate cancer patients' health outcomes via a two-armed randomized controlled trial. The two arms will be (i) the creative arts therapy intervention group and (ii) a active control group.
Participants will join five sessions. Sessions will start with a 10-15-minute rapport-building discussion and continue with a 60-minute intervention. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. Each session will follow a three-step process of psychodynamic model to ensure the optimal effect of the intervention. The interventions will be held at private room at hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creative arts therapy | Experimental | Other: Creative arts therapyThe intervention will be offered throughout five sessions. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. The first individual session, 'bridge drawing', will be used to introduce the creative arts therapy approach and to elaborate on this project. The four other sessions will be group-based (with four participants per group), providing a supportive and communal environment where participants can engage in creative expression alongside others who may have had similar experiences or challenges. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre that has been equipped and prepared for the intervention. |
| Guided group discussions | Active comparator | Other: Guided therapy groupParticipants will engage in guided group discussions over five sessions. Each session will include a guided discussion focusing on self-care topics such as sleep hygiene, dental hygiene, nutrition, and personal interests and hobbies. The first individual session, 'Sleep hygiene, will be used to educate the participants of the importance of sleep and strategies to improve sleep quality. The four other sessions will be group-based (with four participants per group), focusing on dental hygiene, nutrition, personal interests and hobbies and general well-being and reflection. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult participants diagnosed with localised prostate cancer, regardless of the stage and age 18 years or older;
- are not currently receiving active therapy, including chemotherapy, radiotherapy or surgical treatment, by the time of the study or completed treatment more than one year ago and are not on any active treatment;
- were being followed up by the urology team or Department of Surgery at the Chinese University of Hong Kong;
- are willing to participate in the study;
- are able to read Chinese and communicate in Cantonese;
Key exclusion criteria (6 listed)
- Adult participants diagnosed with a mixed type of terminal cancer;
- are undergoing active therapy;
- have participated in other art therapy interventions;
- have physical issues preventing them from holding a pen;
- have a mental status and/or communication problem that might compromise their capacity to give informed consent;
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 |
|---|---|---|
| Guided therapy groupParticipants will engage in guided group discussions over five sessions. Each session will include a guided discussion focusing on self-care topics such as sleep hygiene, dental hygiene, nutrition, and personal interests and hobbies. The first individual session, 'Sleep hygiene, will be used to educate the participants of the importance of sleep and strategies to improve sleep quality. The four other sessions will be group-based (with four participants per group), focusing on dental hygiene, nutrition, personal interests and hobbies and general well-being and reflection. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre. | Other | Guided group discussions |
| Creative arts therapyThe intervention will be offered throughout five sessions. Session themes are as follows: 'bridge drawing', 'analogue drawing', 'life-sized body outline', a 'free session' to allow patients to express their feelings, and a final review with the art therapist in which all sessions will be brought to a conclusion. The first individual session, 'bridge drawing', will be used to introduce the creative arts therapy approach and to elaborate on this project. The four other sessions will be group-based (with four participants per group), providing a supportive and communal environment where participants can engage in creative expression alongside others who may have had similar experiences or challenges. A session will be conducted each week over five weeks, with each session lasting 60 minutes. All sessions will be conducted in a room in the Urology Centre that has been equipped and prepared for the intervention. | Other | Creative arts therapy |
Primary outcome
Body image
Time frame: Baseline and 5 weeks
The Chinese version of the 10-item Body Image Scale (BIS) will be used to assess participants' perception of their body image, including influence, actions and cognition. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The BIS overall summary score ranges from 0 to 30, with a higher score indicating a poorer body image. The BIS was translated by school of nursing team at the Hong Kong Polytechnic University and has been utilised by our team
Self-esteem
Time frame: Baseline and 5 weeks
The Chinese version of the Rosenberg Self-Esteem Scale (RSES) will be used to evaluate participants' general self-esteem. It consists of 10 items assessing positive and negative feelings about the self. Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The RSES overall score ranges from 10 to 40, with a higher score indicating high self-esteem. The RSES version as translated by school of nursing team at the Hong Kong Polytechnic University and has been utilised by our team.
Anxiety and depression
Time frame: Baseline and 5 weeks
The Chinese version of the Hospital Anxiety and Depression Scale (HADS) will be used to assess participants' anxiety and depression levels. The HADS consists of 14 items categorised into two subscales: anxiety and depression. Scores for each subscale are calculated and classified into one of three categories: normal cases (scores of 0-7), borderline cases (scores of 8-10) and cases (scores of 11-21). The Chinese version of the HADS has a strong intercorrelation between anxiety and depression in cancer patients (r = 0.83).
Retention rate
Time frame: Baseline, 5 weeks and 3 months post
The number of patients who remain in the study divided by the number of patients randomised. The retention rate will be calculated for each arm at baseline and follow-ups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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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.
Janelle Yourk, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Guided therapy group and Creative arts therapy in people with Prostate Cancer and Creative Arts Therapy, run by The Hong Kong Polytechnic University.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hammoda ABU-ODAH, PhD (94983446, HAMMODA-MM.ABUODAH@POLYU.EDU.HK), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body image (time frame: Baseline and 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.