NCT07015866

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
15mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

May 23, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

May 23, 2025

Last Update Submit

June 15, 2025

Conditions

Keywords

creative arts therapyprostate cancerbody imageslef-esteemanxietydepressionactive treatment

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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).

    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.

    Baseline, 5 weeks and 3 months post

Study Arms (2)

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.

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.

Other: Guided therapy group

Interventions

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.

Guided group discussions

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.

Creative arts therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Hammoda ABU-ODAH, PhD

CONTACT

Janelle Yourk, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 11, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

June 18, 2025

Record last verified: 2025-06