Advanced CancerNCT07872254
A Feasibility Study of a Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients
A study testing A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients in people with Advanced Cancer and Demoralization, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
Advanced cancer is a leading cause of death worldwide and in China. Cancer patients often face reduced independence and self-care abilities, which may lead to psychological disturbances such as helplessness, hopelessness, or meaninglessness. This combination of these negative emotions is called demoralization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Demoralization, Psychological Intervention
- What is being tested?
- A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2026to 30 Jan 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients ≥18 years old;
- has a confirmed diagnosis of stage III, or IV solid organ tumor, with a life expectancy of more than three months as determine by oncologist;
- receiving undergoing chemotherapy treatment;
- two of the three demoralization-related questions received positive feedback; The three question as follows: i) I find it hard to see any hope; ii) I find what I am going through to be overwhelming; iii) I feel hard to find my sense of worth;
- should be able to use applications (e.g., WeChat) on a mobile phone;
- able to communicate in Putonghua, with voluntary participation in the study;
- answer "No" of the question: "Do you have any thoughts of hurting yourself in some way?";
- co-reside with at least one adult family member.
Who cannot join
- has a diagnosed cognitive impairment or major neurological disorder (e.g., dementia, Alzheimer's disease) that, in the opinion of the treating physician, would preclude the provision of informed consent or meaningful participation;
- has physician-recorded substance or drug use disorder (e.g., alcohol use disorder), which impacts neuropsychological functioning both directly through neurochemistry and indirectly through non-neurological systems;
- is participating in other experimental research, such as psychological intervention (for example: cognitive behaviour therapy and meaning therapy), or psychological counseling;
- the diagnosis is not disclosed to the patients and only the main carer/family is aware.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Seventh Affiliated Hospital of Sun Yat-Sen University
Shenzhen, Guangdong, 518001
Xuan Liu, (+86) 135 3338 4708
Wenbo Dou, Msc
About this study
Official title: Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients: a Feasibility Study
Advanced cancer is a leading cause of death worldwide and in China. Cancer patients often face reduced independence and self-care abilities, which may lead to psychological disturbances such as helplessness, hopelessness, or meaninglessness. This combination of these negative emotions is called demoralization. Approximately 35.8% of cancer patients experience demoralization, with higher rates in terminal stages. If unrecognized or untreated, it can increase physical and mental symptom burden, reduce quality of life, and even lead to suicide. To date, no professional bodies currently recommend treatment guidelines. One meta-analysis suggests that psychological interventions could significantly reduce demoralization; however, the requirement for in-person attendance may create accessibility challenges, potentially reducing the flexibility and acceptability of psychological interventions for cancer patients undergoing chemotherapy or receiving treatment at home.
To address the identified literature gap, a co-designed digital psychological intervention was developed, and this study will evaluate its feasibility. A convenience sample of 30 advanced cancer patients meeting the inclusion criteria will be recruited from the oncology ward of a hospital in Shenzhen. Participants will receive five 30-45 minute sessions of a co-designed, digitally-enabled positive psychological intervention, delivered weekly over five weeks. A trained researcher will introduce the intervention before discharge and deliver it through a WeChat Mini Program in the patients' homes. The primary outcome will be feasibility (time to complete recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, and acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on demoralization, suicidal ideation, and quality of life of advanced cancer patients at baseline (after collecting demographic information and written consent forms) and post-intervention. A separate researcher will conduct a descriptive qualitative evaluation with 12 participants to explore their experience of the intervention. Qualitative data will be audio-taped, transcribed verbatim, and analyzed using NVivo 14 through thematic analysis. Quantitative data will be entered into SPSS version 29.0. Descriptive statistics will be used to summarize the profiles of participants and outcomes.
- Conditions
- Advanced Cancer, Demoralization, Psychological Intervention
- Being tested
- A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients
- Keywords
- Advanced cancer, Demoralization, Positive psychological intervention, Digital health, Suicidal ideation, Quality of life
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digitally-enabled positive psychological intervention for demoralization in advanced cancer patientsBehavioural
The intervention will consist of five 30-45 minute individual digital sessions, delivered weekly over five weeks by a trained registered nurse through a WeChat Mini Program. The five sessions will correspond to the five PERMA dimensions (Positive Emotions, Engagement, Relationships, Meaning, and Accomplishment), grounded in Seligman's PERMA framework, the Positive Psychotherapy Clinician Manual, and the positive psychological interventions training course. This intervention is intended to address the core dimensions of demoralization in advanced cancer patients, particularly hopelessness, meaninglessness, and helplessness, and to translate positive psychological skills into everyday self-care and emotional regulation. The WeChat Mini Program will contain videos, interactive activity modules, and session guides to support the five sessions.
| Study group | Role | What they receive |
|---|---|---|
| A digitally-enabled positive psychological intervention for demoralization | Experimental | A five-week digitally-enabled psychological intervention for demoralization provided by a trained registered nurse Receives: Behavioral: A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome: time to complete the recruitment
Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment.
Measured: Through recruitment completion, up to 3 months
Feasibility outcome: eligibility rate
Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.
Measured: Through recruitment completion, up to 3 months
Feasibility outcome: recruitment rate
Recruitment rate will be calculated by dividing the number of eligible participants who have consented and been enrolled by the total number of eligible participants.
Measured: Through recruitment completion, up to 3 months
Feasibility outcome: retention rate
Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants enrolled at the baseline.
Measured: Through recruitment completion, up to 3 months
Feasibility outcome: attendance rate
Attendance rate will be calculated by dividing the number of participants completed five interventional sessions by the number of participants enrolled at baseline.
Measured: Through recruitment completion, up to 3 months
Acceptability outcome: participants' satisfaction and perspectives of the intervention
Participants' perspectives and satisfaction will be assessed using a self-developed questionnaire, designed for this study based on the Theoretical Framework of Acceptability
Measured: Post-intervention, up to 3 months
Qualitative evaluation of acceptability
A qualitative evaluation will explore the acceptability of the digitally-enabled psychological intervention for demoralization in advanced cancer patients. Semi-structured individual interviews will be conducted after participants complete the intervention, using an interview guide focused on their overall experience and perceived usefulness of the sessions. All interviews will be audio-recorded and transcribed verbatim.
Measured: Post-intervention, up to 3 months
Secondary outcomes (3)
Demoralization
Advanced cancer patients' demoralization will be assessed using the Demoralization Scale-II (DS-II, Chinese version). This scale consists of 16 items, and each item is rated on a three-point Likert scale (0 = not at all to 2 = to a large extent), yielding a total score range of 0-32. Higher scores indicate greater level of demoralization.
Measured: Baseline; Week 5
Suicidal ideation
Advanced cancer patients' suicidal ideation will be assessed using the Beck Scale for Suicidal Ideation (BSSI, Chinese version). This scale consists of 5 items, and each item is rated on a three-point Likert scale (0 = no such thought, attitude, or behavior to 2 = moderate to strong or frequent), yielding a total score range of 0-10. Higher scores indicate greater level of suicidal ideation.
Measured: Baseline; Week 5
Health-related quality of life
Advanced cancer patients' health-related quality of life will be assessed using the the McGill Quality of Life-Revised (MQOL-R, Chinese version). This scale consists of 14 items, and each item is rated on a 11-point Likert scale (0 = very bad to 10 = excellent), yielding a total score range of 0-140. Higher scores indicate greater level of health-related quality of life.
Measured: Baseline; Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Responsible party
- Principal investigator, Dr CHENG Huilin, The Hong Kong Polytechnic University
- Investigators
- Xuan Liu, Study director, The Seventh Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872254
- Sponsor's protocol ID
- 07
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT07872254
- Acronym / sponsor ID
- 07
- Conditions
- Advanced Cancer, Demoralization, Psychological Intervention
- Keywords
- Advanced cancer, Demoralization, Positive psychological intervention, Digital health, Suicidal ideation, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
Advanced cancer is a leading cause of death worldwide and in China. Cancer patients often face reduced independence and self-care abilities, which may lead to psychological disturbances such as helplessness, hopelessness, or meaninglessness. This combination of these negative emotions is called demoralization. Approximately 35.8% of cancer patients experience demoralization, with higher rates in terminal stages. If unrecognized or untreated, it can increase physical and mental symptom burden, reduce quality of life, and even lead to suicide. To date, no professional bodies currently recommend treatment guidelines. One meta-analysis suggests that psychological interventions could significantly reduce demoralization; however, the requirement for in-person attendance may create accessibility challenges, potentially reducing the flexibility and acceptability of psychological interventions for cancer patients undergoing chemotherapy or receiving treatment at home.
To address the identified literature gap, a co-designed digital psychological intervention was developed, and this study will evaluate its feasibility. A convenience sample of 30 advanced cancer patients meeting the inclusion criteria will be recruited from the oncology ward of a hospital in Shenzhen. Participants will receive five 30-45 minute sessions of a co-designed, digitally-enabled positive psychological intervention, delivered weekly over five weeks. A trained researcher will introduce the intervention before discharge and deliver it through a WeChat Mini Program in the patients' homes. The primary outcome will be feasibility (time to complete recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, and acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on demoralization, suicidal ideation, and quality of life of advanced cancer patients at baseline (after collecting demographic information and written consent forms) and post-intervention. A separate researcher will conduct a descriptive qualitative evaluation with 12 participants to explore their experience of the intervention. Qualitative data will be audio-taped, transcribed verbatim, and analyzed using NVivo 14 through thematic analysis. Quantitative data will be entered into SPSS version 29.0. Descriptive statistics will be used to summarize the profiles of participants and outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A digitally-enabled positive psychological intervention for demoralization | Experimental | Behavioral: A digitally-enabled positive psychological intervention for demoralization in advanced cancer patientsA five-week digitally-enabled psychological intervention for demoralization provided by a trained registered nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adult patients ≥18 years old;
- has a confirmed diagnosis of stage III, or IV solid organ tumor, with a life expectancy of more than three months as determine by oncologist;
- receiving undergoing chemotherapy treatment;
- two of the three demoralization-related questions received positive feedback; The three question as follows: i) I find it hard to see any hope; ii) I find what I am going through to be overwhelming; iii) I feel hard to find my sense of worth;
- should be able to use applications (e.g., WeChat) on a mobile phone;
Key exclusion criteria (4 listed)
- has a diagnosed cognitive impairment or major neurological disorder (e.g., dementia, Alzheimer's disease) that, in the opinion of the treating physician, would preclude the provision of informed consent or meaningful participation;
- has physician-recorded substance or drug use disorder (e.g., alcohol use disorder), which impacts neuropsychological functioning both directly through neurochemistry and indirectly through non-neurological systems;
- is participating in other experimental research, such as psychological intervention (for example: cognitive behaviour therapy and meaning therapy), or psychological counseling;
- the diagnosis is not disclosed to the patients and only the main carer/family is aware.
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 |
|---|---|---|
| A digitally-enabled positive psychological intervention for demoralization in advanced cancer patientsThe intervention will consist of five 30-45 minute individual digital sessions, delivered weekly over five weeks by a trained registered nurse through a WeChat Mini Program. The five sessions will correspond to the five PERMA dimensions (Positive Emotions, Engagement, Relationships, Meaning, and Accomplishment), grounded in Seligman's PERMA framework, the Positive Psychotherapy Clinician Manual, and the positive psychological interventions training course. This intervention is intended to address the core dimensions of demoralization in advanced cancer patients, particularly hopelessness, meaninglessness, and helplessness, and to translate positive psychological skills into everyday self-care and emotional regulation. The WeChat Mini Program will contain videos, interactive activity modules, and session guides to support the five sessions. | Behavioural | A digitally-enabled positive psychological intervention for demoralization |
Primary outcome
Feasibility outcome: time to complete the recruitment
Time frame: Through recruitment completion, up to 3 months
Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment.
Feasibility outcome: eligibility rate
Time frame: Through recruitment completion, up to 3 months
Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.
Feasibility outcome: recruitment rate
Time frame: Through recruitment completion, up to 3 months
Recruitment rate will be calculated by dividing the number of eligible participants who have consented and been enrolled by the total number of eligible participants.
Feasibility outcome: retention rate
Time frame: Through recruitment completion, up to 3 months
Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants enrolled at the baseline.
Feasibility outcome: attendance rate
Time frame: Through recruitment completion, up to 3 months
Attendance rate will be calculated by dividing the number of participants completed five interventional sessions by the number of participants enrolled at baseline.
Acceptability outcome: participants' satisfaction and perspectives of the intervention
Time frame: Post-intervention, up to 3 months
Participants' perspectives and satisfaction will be assessed using a self-developed questionnaire, designed for this study based on the Theoretical Framework of Acceptability
Qualitative evaluation of acceptability
Time frame: Post-intervention, up to 3 months
A qualitative evaluation will explore the acceptability of the digitally-enabled psychological intervention for demoralization in advanced cancer patients. Semi-structured individual interviews will be conducted after participants complete the intervention, using an interview guide focused on their overall experience and perceived usefulness of the sessions. All interviews will be audio-recorded and transcribed verbatim.
3 secondary outcomes
Demoralization
Time frame: Baseline; Week 5
Suicidal ideation
Time frame: Baseline; Week 5
Health-related quality of life
Time frame: Baseline; Week 5
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Xuan Liu study director
The Seventh Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients in people with Advanced Cancer and Demoralization, run by The Hong Kong Polytechnic University at 1 site 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 8 inclusion and 4 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Wenbo Dou ((+86) 175 0893 9982, wen-bo.dou@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome: time to complete the recruitment (time frame: Through recruitment completion, up to 3 months). The study lists 7 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 13 Oct 2026.