An interventional study of A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients in Advanced Cancer, Demoralization and Psychological Intervention, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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.
530 studies on the registry are indexed under Suicidal Ideation; 198 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 440 interventional studies indexed under Suicidal Ideation.
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Exclusion Criteria:
A five-week digitally-enabled psychological intervention for demoralization provided by a trained registered nurse
Behavioral: A digitally-enabled positive psychological intervention for demoralization in advanced cancer patients
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Post-intervention, up to 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Week 5
Plan to share: No
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