Primary Caregiver Readiness for Care and Psychological Resilience in Palliative CareNCT07799389
Nurse-Led AI-Supported Psychosocial Support for Palliative Caregivers
A study testing Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program and Routine Care and Information in people with Primary Caregiver Readiness for Care and Psychological Resilience in Palliative Care, run by Kastamonu University.
Trial summary
Primary caregivers of palliative care patients assume responsibility for meeting the patient's needs, monitoring symptoms, maintaining care practices, and managing changing needs. Increased responsibilities, uncertainty, and lack of information and support can negatively impact caregivers' psychosocial adjustment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Caregiver Readiness for Care and Psychological Resilience in Palliative Care
- What is being tested?
- Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program and Routine Care and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 20 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older. Being the primary caregiver of a patient receiving palliative care. Providing unpaid caregiving. Being able to read, understand, and communicate in Turkish. Having sufficient cognitive and communication abilities to complete the data collection instruments.
- Being able to use the generative AI-supported program with the explanation and technical support provided by the researcher, when necessary.
- Voluntarily agreeing to participate in the six-week intervention program and providing written informed consent.
Who cannot join
- -Not being the primary caregiver of the palliative care patient. Providing caregiving services for payment. Having cognitive, visual, auditory, or communication difficulties that prevent understanding the data collection instruments or using the program despite the support provided.
- Concurrently participating in another structured psychoeducational or psychosocial support program for caregivers.
- Not having the capacity to participate in the study or provide informed consent.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program on the Care Readiness and Psychological Resilience of Primary Caregivers of Palliative Care Patients
Primary caregivers of palliative care patients assume responsibility for meeting the patient's needs, monitoring symptoms, maintaining care practices, and managing changing needs. Increased responsibilities, uncertainty, and lack of information and support can negatively impact caregivers' psychosocial adjustment. The aim of this research is to evaluate the impact of a nurse-led, generative artificial intelligence-supported individualized psychosocial support program on the care readiness and psychological resilience levels of primary caregivers of palliative care patients. The six-week program will consist of six modules: adaptation to the care role, understanding care needs and coping with uncertainty, stress and emotion regulation, adaptive coping and problem-solving, self-care and social support, and making sense of the care experience and supporting strengths. Standard content, which will be evaluated with expert opinion, will be individualized according to the caregivers' needs and responses during the program. Generative artificial intelligence will be used as a nurse-supervised psychoeducational support tool within the framework of a validated knowledge base and safety rules. The research will be conducted using a pre-test-post-test, parallel-group randomized controlled experimental design. A total of 88 primary caregivers will be assigned to experimental and control groups in a 1:1 ratio. The control group will receive routine care and information, while the experimental group will receive these in addition to a psychosocial support program. Data will be collected before and immediately after the intervention using the Caregiver Demographic Information Form, the Caregiver Readiness Scale, and the Psychological Resilience Scale for Adults. Additionally, the overall satisfaction levels of participants in the experimental group regarding the program will be evaluated using a scale of 1-10. The findings are expected to provide scientific evidence for the development of individualized nursing interventions that support caregivers' preparation for the caregiving role and their psychological resilience, and for the safe, effective, and human-supervised use of generative artificial intelligence.
Read the detailed description
This randomized controlled trial will evaluate the effect of a nurse-led, generative artificial intelligence (AI)-supported individualized psychosocial support program on the care readiness and psychological resilience of primary caregivers of patients receiving palliative care. Palliative care is a holistic approach that aims to improve the quality of life of patients and their families facing problems associated with life-threatening illnesses through the early identification, accurate assessment, and treatment of pain and other physical, psychosocial, and spiritual problems (WHO, 2020). Palliative care also includes a team-based approach that provides support to patients, their families, and caregivers. Primary caregivers undertake a substantial proportion of patients' daily living and care needs, including assistance with activities of daily living and self-care, medication management, communication with healthcare professionals, and emotional, social, and spiritual support (Pinto et al., 2026).
As the disease progresses, increasing caregiving responsibilities, uncertainty about the future, and the possibility of death may result in considerable physical, emotional, and psychosocial challenges for caregivers. Caregivers may not always feel adequately prepared for the caregiving role and may experience difficulties accessing the support they need (Hudson, 2003; McAndrew et al., 2023). These challenges may become particularly evident during the transition from hospital to home. Previous research involving palliative care patients and their caregivers has shown that positive transition experiences are associated with adequate support, the ability to manage medications, and the fulfillment of healthcare needs, whereas unclear caregiving responsibilities, medication-related confusion, uncertainty, and emotional distress may complicate the transition process (Saunders et al., 2021). Caregiver needs also continue after discharge, including adaptation to changing caregiving responsibilities, emotional regulation, coping with difficulties, use of available support resources, and maintenance of self-care (Hudson, 2003; McAndrew et al., 2023).
Care readiness is an important factor influencing caregivers' ability to participate effectively in the caregiving process. Care readiness refers to the extent to which caregivers perceive themselves as prepared to fulfill the physical, emotional, and practical requirements of the caregiving role and to cope with the stress associated with caregiving (Karaman \& Karadakovan, 2015). Higher levels of care readiness have been associated with lower levels of depression and caregiver burden among caregivers of individuals with Alzheimer's disease and related dementias (Hancock et al., 2022). Among family caregivers of patients with advanced cancer, support from healthcare professionals and communication about the illness have also been associated with higher levels of care readiness (Häger Tibell et al., 2024). A systematic review and meta-analysis indicated that psychoeducational, educational, supportive, and self-care-oriented interventions may have beneficial effects on caregivers' readiness for caregiving (Bilgin \& Özdemir, 2022). Similarly, an intervention based on the identification of individual caregiver support needs was associated with a significant increase in care readiness scores following the intervention (Norinder et al., 2024). However, a web-based psychoeducational intervention for family caregivers of patients receiving palliative home care did not demonstrate a significant effect on care readiness compared with the control group, potentially due to limited user engagement; the authors recommended greater integration of such programs into clinical care processes (Bauman et al., 2025).
Psychological resilience represents another important psychosocial resource associated with adaptation to caregiving. Psychological resilience refers to an individual's capacity to adapt to adversity, maintain functioning, and recover following stressful experiences. It is considered a multidimensional construct involving self-perception, future orientation, behavioral and structural characteristics, social skills, family functioning, and social support (Basım \& Çetin, 2011). Among family caregivers of patients with advanced cancer, higher psychological resilience has been associated with greater care readiness and lower levels of anxiety and depressive symptoms (Dionne-Odom et al., 2021). Among family caregivers of patients in the terminal stage, adaptive coping strategies such as active coping, acceptance, positive reframing, planning, and humor have been associated with higher psychological resilience (Shimizu et al., 2025). Psychoeducational interventions may support caregivers' ability to cope with caregiving-related stress and promote psychological adaptation. In a quasi-experimental study of caregivers of patients with amyotrophic lateral sclerosis, a six-week online psychoeducational program resulted in significantly higher psychological resilience and self-compassion scores in the intervention group compared with the control group (Duran \& Aydoğdu, 2024). Similarly, a randomized controlled trial among caregivers of adolescents and young adults with cancer found that a psychoeducational intervention delivered through mobile instant messaging reduced unmet caregiver needs, anxiety, and depressive symptoms (Cheng et al., 2024).
Generative AI may provide opportunities to deliver individualized explanations, case examples, and psychoeducational feedback according to caregivers' needs. However, because generative AI systems have important limitations regarding accuracy and reliability, they should not replace clinical assessment by nurses or other healthcare professionals and should be used under appropriate professional supervision (Tischendorf et al., 2025). In a study evaluating a domain-specific generative AI agent developed to support families of children and adolescents with anorexia nervosa, 91.6% of 477 responses were considered clinically appropriate by experts. However, the study was limited to system development and expert evaluation, and its effects on caregivers' psychosocial outcomes were not examined (Hanzawa et al., 2026). AI-supported systems in palliative care may have potential to provide patients and caregivers with information, emotional support, and practical assistance (Jafari Dehnayebi et al., 2026). A scoping review of AI applications for individuals with serious illnesses and their family caregivers in home settings indicated that these technologies may facilitate individualized care, continuity of care, emotional support, and caregiver support. Nevertheless, most existing studies have focused on feasibility, usability, and user experience, while research evaluating clinical and psychosocial outcomes remains limited (Xiao et al., 2026). Furthermore, a systematic review of AI applications in palliative care reported that 86% of the included studies were retrospective or proof-of-concept studies, with only seven randomized controlled trials and six prospective studies identified. These limitations highlight the need for controlled studies evaluating the effects of AI-supported interventions on psychosocial outcomes among caregivers in palliative care (Bozkurt et al., 2025).
In this trial, generative AI will be used as a nurse-supervised supportive tool rather than as an autonomous clinical decision-maker. The intervention content will be developed by the research team and validated through expert review. Predefined safety rules and standardized core content will be used throughout the intervention. The six-week program will consist of six modules: (1) adaptation to the caregiving role and care readiness, (2) understanding caregiving needs and coping with uncertainty, (3) stress management and emotional regulation, (4) adaptive coping and problem solving, (5) self-care and social support, and (6) meaning-making and strengthening personal resources related to the caregiving experience. The standardized core content will be maintained for all participants, while explanations, information cards, case examples, brief exercises, mini-questions, and psychoeducational feedback will be individualized according to the caregiver's psychosocial needs, caregiving experience, responses during the program, and basic characteristics of the patient's care needs.
The generative AI system will not independently diagnose psychological or clinical conditions, make treatment decisions, modify medical treatment, or replace professional nursing assessment. The nurse will maintain an active supervisory role throughout the intervention and will evaluate participant responses according to predefined monitoring procedures. When responses indicate a need for clinical assessment, additional psychological support, or referral to another healthcare professional, the nurse will initiate the appropriate referral process.
The primary outcomes of the trial will be care readiness and psychological resilience among primary caregivers of palliative care patients. Changes in these outcomes will be evaluated between the intervention and control groups at predefined assessment time points. The study aims to determine whether a nurse-led, generative AI-supported individualized psychosocial support program can improve caregivers' preparedness for the caregiving role and psychological resilience.
By evaluating a professionally supervised generative AI-supported psychosocial intervention in a randomized controlled design, this study is expected to contribute empirical evidence to the limited literature on the clinical and psychosocial effectiveness of generative AI interventions for caregivers in palliative care.
- Being tested
- Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program, Routine Care and Information
- Keywords
- Palliative care, primary caregiver, readiness to provide care, psychological resilience, psychosocial support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led, Generative AI-Supported Individualized Psychosocial Support ProgramBehavioural
A six-week, nurse-led, generative AI-supported individualized psychosocial support program for primary caregivers of palliative care patients. The program consists of six modules: (1) adaptation to the caregiving role and care readiness, (2) understanding caregiving needs and coping with uncertainty, (3) stress management and emotion regulation, (4) adaptive coping and problem solving, (5) self-care and social support, and (6) meaning-making and strengthening personal resources. Standardized core content will be individualized according to caregivers' psychosocial needs, caregiving experiences, responses during the program, and basic characteristics of the patient's care needs. Generative AI will be used as a nurse-supervised psychoeducational support tool based on expert-validated content and predefined safety rules.
Routine Care and InformationBehavioural
Participants will receive routine care and information provided by the institution during the study period. They will not receive the nurse-led, generative AI-supported individualized psychosocial support program.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program | Experimental | Participants will receive routine care and information provided by the institution in addition to a six-week, nurse-led, generative AI-supported individualized psychosocial support program. The program consists of six modules addressing adaptation to the caregiving role and care readiness, understanding care needs and coping with uncertainty, stress and emotion regulation, adaptive coping and problem solving, self-care and social support, and meaning-making and strengthening personal resources. Generative AI will be used as a nurse-supervised psychoeducational support tool based on expert-validated content and predefined safety rules. The content will be individualized according to caregivers' psychosocial needs, caregiving experiences, responses during the program, and basic characteristics of the patient's care needs. Receives: Behavioral: Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program |
| Routine Care and Information | Experimental | Participants will receive routine care and information provided by the institution during the study period. They will not receive the nurse-led, generative AI-supported individualized psychosocial support program Receives: Behavioral: Routine Care and Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline (pretest) and immediately after the six-week intervention (posttest)
Care readiness of primary caregivers will be assessed using the Caregiver Readiness Scale. The scale evaluates caregivers' perceived readiness to fulfill the physical, emotional, and practical requirements of the caregiving role and to cope with caregiving-related stress. Higher scores indicate a higher level of care readiness.
Measured: Baseline (pretest) and immediately after the six-week intervention (posttest)
Secondary outcomes (1)
Baseline (pretest) and immediately after the six-week intervention (posttest)
Psychological resilience of primary caregivers will be assessed using the Psychological Resilience Scale for Adults. The scale consists of 33 items and evaluates self-perception, future perception, structural style, social competence, family cohesion, and social resources. Higher scores indicate higher psychological resilience.
Measured: Baseline (pretest) and immediately after the six-week intervention (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Caregiver Readiness for Care and Psychological Resilience in Palliative CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-arm, parallel-group, randomized controlled experimental trial with a pretest-posttest design. Eligible primary caregivers of palliative care patients will be individually randomized in a 1:1 ratio to either the intervention group or the control group. The control group will receive routine care and information provided by the institution, whereas the intervention group will receive routine care and information in addition to a six-week, nurse-led, generative AI-supported individualized psychosocial support program. The intervention consists of six modules addressing adaptation to the caregiving role and care readiness, understanding care needs and coping with uncertainty, stress and emotion regulation, adaptive coping and problem solving, self-care and social support, and meaning-making and strengthening personal resources.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Kaçan, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799389
- Sponsor's protocol ID
- KAEK-121 2026-31
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, a decision regarding the sharing of individual participant-level data with other researchers has not yet been made. Any future data-sharing decision will be made in accordance with applicable ethical requirements, participant consent, data protection regulations, and institutional policies.
Publications
1. Basım, H. N., & Çetin, F. (2011). Yetişkinler için Psikolojik Dayanıklılık Ölçeği'nin güvenilirlik ve geçerlilik çalışması. Türk Psikiyatri Dergisi, 22(2), 104-114. 2. Bauman, C., Årestedt, K., Wallin, V., Häger Tibell, L., Fürst, P., Hudson, P., Kreicbergs, U., & Alvariza, A. (2025). Web-based psychoeducational intervention to improve family caregiver preparedness in specialized palliative home care: A randomized controlled trial. Psycho-Oncology, 34, e70202. https://doi.org/10.1002/pon.70202 3. Bilgin, A., & Özdemir, L. (2022). Interventions to improve the preparedness to care for family caregivers of cancer patients: A systematic review and meta-analysis. Cancer Nursing, 45(3), E689-E705. https://doi.org/10.1097/NCC.0000000000001014 4. Bozkurt, S., Fereydooni, S., Kar, I., Diop Chalmers, C., Leslie, S. L., Pathak, R., Walling, A. M., Lindvall, C., Lorenz, K., Parikh, R., Quest, T., Giannitrapani, K., & Kavalieratos, D. (2025). AI in palliative care: A scoping review of foundational gaps and future directions for responsible innovation. Journal of Pain and Symptom Management, 70(6), e394-e418. https://doi.org/10.1016/j.jpainsymman.2025.08.009 5. Caetano, P., Querido, A., & Laranjeira, C. (2024). Preparedness for caregiving role and telehealth use to provide informal palliative home care in Portugal: A qualitative study. Healthcare, 12(19), 1915. https://doi.org/10.3390/healthcare12191915 6. Cheng, Q., Ng, M. S. N., Choi, K. C., Chen, Y., Liu, G., & So, W. K. W. (2024). A mobile instant messaging-delivered psychoeducational intervention for cancer caregivers: A randomized clinical trial. JAMA Network Open, 7(2), e2356522. https://doi.org/10.1001/jamanetworkopen.2023.56522 7. Dionne-Odom, J. N., Azuero, A., Taylor, R. A., Wells, R. D., Hendricks, B. A., Bechthold, A. C., Reed, R. D., Harrell, E. R., Dosse, C. K., Engler, S., McKie, P., Ejem, D., Bakitas, M. A., & Rosenberg, A. R. (2021). Resilience, preparedness, and distress among family caregivers of patients w
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program on the Care Readiness and Psychological Resilience of Primary Caregivers of Palliative Care Patients
- ClinicalTrials.gov ID
- NCT07799389
- Acronym / sponsor ID
- KAEK-121 2026-31
- Keywords
- Palliative care, primary caregiver, readiness to provide care, psychological resilience, psychosocial support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 2 Sep 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.
Primary caregivers of palliative care patients assume responsibility for meeting the patient's needs, monitoring symptoms, maintaining care practices, and managing changing needs. Increased responsibilities, uncertainty, and lack of information and support can negatively impact caregivers' psychosocial adjustment. The aim of this research is to evaluate the impact of a nurse-led, generative artificial intelligence-supported individualized psychosocial support program on the care readiness and psychological resilience levels of primary caregivers of palliative care patients. The six-week program will consist of six modules: adaptation to the care role, understanding care needs and coping with uncertainty, stress and emotion regulation, adaptive coping and problem-solving, self-care and social support, and making sense of the care experience and supporting strengths. Standard content, which will be evaluated with expert opinion, will be individualized according to the caregivers' needs and responses during the program. Generative artificial intelligence will be used as a nurse-supervised psychoeducational support tool within the framework of a validated knowledge base and safety rules. The research will be conducted using a pre-test-post-test, parallel-group randomized controlled experimental design. A total of 88 primary caregivers will be assigned to experimental and control groups in a 1:1 ratio. The control group will receive routine care and information, while the experimental group will receive these in addition to a psychosocial support program. Data will be collected before and immediately after the intervention using the Caregiver Demographic Information Form, the Caregiver Readiness Scale, and the Psychological Resilience Scale for Adults. Additionally, the overall satisfaction levels of participants in the experimental group regarding the program will be evaluated using a scale of 1-10. The findings are expected to provide scientific evidence for the development of individualized nursing interventions that support caregivers' preparation for the caregiving role and their psychological resilience, and for the safe, effective, and human-supervised use of generative artificial intelligence.
Detailed description
This randomized controlled trial will evaluate the effect of a nurse-led, generative artificial intelligence (AI)-supported individualized psychosocial support program on the care readiness and psychological resilience of primary caregivers of patients receiving palliative care. Palliative care is a holistic approach that aims to improve the quality of life of patients and their families facing problems associated with life-threatening illnesses through the early identification, accurate assessment, and treatment of pain and other physical, psychosocial, and spiritual problems (WHO, 2020). Palliative care also includes a team-based approach that provides support to patients, their families, and caregivers. Primary caregivers undertake a substantial proportion of patients' daily living and care needs, including assistance with activities of daily living and self-care, medication management, communication with healthcare professionals, and emotional, social, and spiritual support (Pinto et al., 2026).
As the disease progresses, increasing caregiving responsibilities, uncertainty about the future, and the possibility of death may result in considerable physical, emotional, and psychosocial challenges for caregivers. Caregivers may not always feel adequately prepared for the caregiving role and may experience difficulties accessing the support they need (Hudson, 2003; McAndrew et al., 2023). These challenges may become particularly evident during the transition from hospital to home. Previous research involving palliative care patients and their caregivers has shown that positive transition experiences are associated with adequate support, the ability to manage medications, and the fulfillment of healthcare needs, whereas unclear caregiving responsibilities, medication-related confusion, uncertainty, and emotional distress may complicate the transition process (Saunders et al., 2021). Caregiver needs also continue after discharge, including adaptation to changing caregiving responsibilities, emotional regulation, coping with difficulties, use of available support resources, and maintenance of self-care (Hudson, 2003; McAndrew et al., 2023).
Care readiness is an important factor influencing caregivers' ability to participate effectively in the caregiving process. Care readiness refers to the extent to which caregivers perceive themselves as prepared to fulfill the physical, emotional, and practical requirements of the caregiving role and to cope with the stress associated with caregiving (Karaman \& Karadakovan, 2015). Higher levels of care readiness have been associated with lower levels of depression and caregiver burden among caregivers of individuals with Alzheimer's disease and related dementias (Hancock et al., 2022). Among family caregivers of patients with advanced cancer, support from healthcare professionals and communication about the illness have also been associated with higher levels of care readiness (Häger Tibell et al., 2024). A systematic review and meta-analysis indicated that psychoeducational, educational, supportive, and self-care-oriented interventions may have beneficial effects on caregivers' readiness for caregiving (Bilgin \& Özdemir, 2022). Similarly, an intervention based on the identification of individual caregiver support needs was associated with a significant increase in care readiness scores following the intervention (Norinder et al., 2024). However, a web-based psychoeducational intervention for family caregivers of patients receiving palliative home care did not demonstrate a significant effect on care readiness compared with the control group, potentially due to limited user engagement; the authors recommended greater integration of such programs into clinical care processes (Bauman et al., 2025).
Psychological resilience represents another important psychosocial resource associated with adaptation to caregiving. Psychological resilience refers to an individual's capacity to adapt to adversity, maintain functioning, and recover following stressful experiences. It is considered a multidimensional construct involving self-perception, future orientation, behavioral and structural characteristics, social skills, family functioning, and social support (Basım \& Çetin, 2011). Among family caregivers of patients with advanced cancer, higher psychological resilience has been associated with greater care readiness and lower levels of anxiety and depressive symptoms (Dionne-Odom et al., 2021). Among family caregivers of patients in the terminal stage, adaptive coping strategies such as active coping, acceptance, positive reframing, planning, and humor have been associated with higher psychological resilience (Shimizu et al., 2025). Psychoeducational interventions may support caregivers' ability to cope with caregiving-related stress and promote psychological adaptation. In a quasi-experimental study of caregivers of patients with amyotrophic lateral sclerosis, a six-week online psychoeducational program resulted in significantly higher psychological resilience and self-compassion scores in the intervention group compared with the control group (Duran \& Aydoğdu, 2024). Similarly, a randomized controlled trial among caregivers of adolescents and young adults with cancer found that a psychoeducational intervention delivered through mobile instant messaging reduced unmet caregiver needs, anxiety, and depressive symptoms (Cheng et al., 2024).
Generative AI may provide opportunities to deliver individualized explanations, case examples, and psychoeducational feedback according to caregivers' needs. However, because generative AI systems have important limitations regarding accuracy and reliability, they should not replace clinical assessment by nurses or other healthcare professionals and should be used under appropriate professional supervision (Tischendorf et al., 2025). In a study evaluating a domain-specific generative AI agent developed to support families of children and adolescents with anorexia nervosa, 91.6% of 477 responses were considered clinically appropriate by experts. However, the study was limited to system development and expert evaluation, and its effects on caregivers' psychosocial outcomes were not examined (Hanzawa et al., 2026). AI-supported systems in palliative care may have potential to provide patients and caregivers with information, emotional support, and practical assistance (Jafari Dehnayebi et al., 2026). A scoping review of AI applications for individuals with serious illnesses and their family caregivers in home settings indicated that these technologies may facilitate individualized care, continuity of care, emotional support, and caregiver support. Nevertheless, most existing studies have focused on feasibility, usability, and user experience, while research evaluating clinical and psychosocial outcomes remains limited (Xiao et al., 2026). Furthermore, a systematic review of AI applications in palliative care reported that 86% of the included studies were retrospective or proof-of-concept studies, with only seven randomized controlled trials and six prospective studies identified. These limitations highlight the need for controlled studies evaluating the effects of AI-supported interventions on psychosocial outcomes among caregivers in palliative care (Bozkurt et al., 2025).
In this trial, generative AI will be used as a nurse-supervised supportive tool rather than as an autonomous clinical decision-maker. The intervention content will be developed by the research team and validated through expert review. Predefined safety rules and standardized core content will be used throughout the intervention. The six-week program will consist of six modules: (1) adaptation to the caregiving role and care readiness, (2) understanding caregiving needs and coping with uncertainty, (3) stress management and emotional regulation, (4) adaptive coping and problem solving, (5) self-care and social support, and (6) meaning-making and strengthening personal resources related to the caregiving experience. The standardized core content will be maintained for all participants, while explanations, information cards, case examples, brief exercises, mini-questions, and psychoeducational feedback will be individualized according to the caregiver's psychosocial needs, caregiving experience, responses during the program, and basic characteristics of the patient's care needs.
The generative AI system will not independently diagnose psychological or clinical conditions, make treatment decisions, modify medical treatment, or replace professional nursing assessment. The nurse will maintain an active supervisory role throughout the intervention and will evaluate participant responses according to predefined monitoring procedures. When responses indicate a need for clinical assessment, additional psychological support, or referral to another healthcare professional, the nurse will initiate the appropriate referral process.
The primary outcomes of the trial will be care readiness and psychological resilience among primary caregivers of palliative care patients. Changes in these outcomes will be evaluated between the intervention and control groups at predefined assessment time points. The study aims to determine whether a nurse-led, generative AI-supported individualized psychosocial support program can improve caregivers' preparedness for the caregiving role and psychological resilience.
By evaluating a professionally supervised generative AI-supported psychosocial intervention in a randomized controlled design, this study is expected to contribute empirical evidence to the limited literature on the clinical and psychosocial effectiveness of generative AI interventions for caregivers in palliative care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a two-arm, parallel-group, randomized controlled experimental trial with a pretest-posttest design. Eligible primary caregivers of palliative care patients will be individually randomized in a 1:1 ratio to either the intervention group or the control group. The control group will receive routine care and information provided by the institution, whereas the intervention group will receive routine care and information in addition to a six-week, nurse-led, generative AI-supported individualized psychosocial support program. The intervention consists of six modules addressing adaptation to the caregiving role and care readiness, understanding care needs and coping with uncertainty, stress and emotion regulation, adaptive coping and problem solving, self-care and social support, and meaning-making and strengthening personal resources.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program | Experimental | Behavioral: Nurse-Led, Generative AI-Supported Individualized Psychosocial Support ProgramParticipants will receive routine care and information provided by the institution in addition to a six-week, nurse-led, generative AI-supported individualized psychosocial support program. The program consists of six modules addressing adaptation to the caregiving role and care readiness, understanding care needs and coping with uncertainty, stress and emotion regulation, adaptive coping and problem solving, self-care and social support, and meaning-making and strengthening personal resources. Generative AI will be used as a nurse-supervised psychoeducational support tool based on expert-validated content and predefined safety rules. The content will be individualized according to caregivers' psychosocial needs, caregiving experiences, responses during the program, and basic characteristics of the patient's care needs. |
| Routine Care and Information | Experimental | Behavioral: Routine Care and InformationParticipants will receive routine care and information provided by the institution during the study period. They will not receive the nurse-led, generative AI-supported individualized psychosocial support program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older. Being the primary caregiver of a patient receiving palliative care. Providing unpaid caregiving. Being able to read, understand, and communicate in Turkish. Having sufficient cognitive and communication abilities to complete the data collection instruments.
- Being able to use the generative AI-supported program with the explanation and technical support provided by the researcher, when necessary.
- Voluntarily agreeing to participate in the six-week intervention program and providing written informed consent.
Key exclusion criteria (4 listed)
- -Not being the primary caregiver of the palliative care patient. Providing caregiving services for payment. Having cognitive, visual, auditory, or communication difficulties that prevent understanding the data collection instruments or using the program despite the support provided.
- Concurrently participating in another structured psychoeducational or psychosocial support program for caregivers.
- Not having the capacity to participate in the study or provide 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 |
|---|---|---|
| Nurse-Led, Generative AI-Supported Individualized Psychosocial Support ProgramA six-week, nurse-led, generative AI-supported individualized psychosocial support program for primary caregivers of palliative care patients. The program consists of six modules: (1) adaptation to the caregiving role and care readiness, (2) understanding caregiving needs and coping with uncertainty, (3) stress management and emotion regulation, (4) adaptive coping and problem solving, (5) self-care and social support, and (6) meaning-making and strengthening personal resources. Standardized core content will be individualized according to caregivers' psychosocial needs, caregiving experiences, responses during the program, and basic characteristics of the patient's care needs. Generative AI will be used as a nurse-supervised psychoeducational support tool based on expert-validated content and predefined safety rules. | Behavioural | Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program |
| Routine Care and InformationParticipants will receive routine care and information provided by the institution during the study period. They will not receive the nurse-led, generative AI-supported individualized psychosocial support program. | Behavioural | Routine Care and Information |
Primary outcome
Baseline (pretest) and immediately after the six-week intervention (posttest)
Time frame: Baseline (pretest) and immediately after the six-week intervention (posttest)
Care readiness of primary caregivers will be assessed using the Caregiver Readiness Scale. The scale evaluates caregivers' perceived readiness to fulfill the physical, emotional, and practical requirements of the caregiving role and to cope with caregiving-related stress. Higher scores indicate a higher level of care readiness.
1 secondary outcome
Baseline (pretest) and immediately after the six-week intervention (posttest)
Time frame: Baseline (pretest) and immediately after the six-week intervention (posttest)
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 16 Oct 2026.
- Results publication1. Basım, H. N., & Çetin, F. (2011). Yetişkinler için Psikolojik Dayanıklılık Ölçeği'nin güvenilirlik ve geçerlilik çalışması. Türk Psikiyatri Dergisi, 22(2), 104-114. 2. Bauman, C., Årestedt, K., Wallin, V., Häger Tibell, L., Fürst, P., Hudson, P., Kreicbergs, U., & Alvariza, A. (2025). Web-based psychoeducational intervention to improve family caregiver preparedness in specialized palliative home care: A randomized controlled trial. Psycho-Oncology, 34, e70202. https://doi.org/10.1002/pon.70202 3. Bilgin, A., & Özdemir, L. (2022). Interventions to improve the preparedness to care for family caregivers of cancer patients: A systematic review and meta-analysis. Cancer Nursing, 45(3), E689-E705. https://doi.org/10.1097/NCC.0000000000001014 4. Bozkurt, S., Fereydooni, S., Kar, I., Diop Chalmers, C., Leslie, S. L., Pathak, R., Walling, A. M., Lindvall, C., Lorenz, K., Parikh, R., Quest, T., Giannitrapani, K., & Kavalieratos, D. (2025). AI in palliative care: A scoping review of foundational gaps and future directions for responsible innovation. Journal of Pain and Symptom Management, 70(6), e394-e418. https://doi.org/10.1016/j.jpainsymman.2025.08.009 5. Caetano, P., Querido, A., & Laranjeira, C. (2024). Preparedness for caregiving role and telehealth use to provide informal palliative home care in Portugal: A qualitative study. Healthcare, 12(19), 1915. https://doi.org/10.3390/healthcare12191915 6. Cheng, Q., Ng, M. S. N., Choi, K. C., Chen, Y., Liu, G., & So, W. K. W. (2024). A mobile instant messaging-delivered psychoeducational intervention for cancer caregivers: A randomized clinical trial. JAMA Network Open, 7(2), e2356522. https://doi.org/10.1001/jamanetworkopen.2023.56522 7. Dionne-Odom, J. N., Azuero, A., Taylor, R. A., Wells, R. D., Hendricks, B. A., Bechthold, A. C., Reed, R. D., Harrell, E. R., Dosse, C. K., Engler, S., McKie, P., Ejem, D., Bakitas, M. A., & Rosenberg, A. R. (2021). Resilience, preparedness, and distress among family caregivers of patients w
- Individual participant dataSharing planned: Undecided. At this stage, a decision regarding the sharing of individual participant-level data with other researchers has not yet been made. Any future data-sharing decision will be made in accordance with applicable ethical requirements, participant consent, data protection regulations, and institutional policies.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led, Generative AI-Supported Individualized Psychosocial Support Program and Routine Care and Information in people with Primary Caregiver Readiness for Care and Psychological Resilience in Palliative Care, run by Kastamonu 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 3 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 16 Oct 2026. 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 Havva KAÇAN, associate professor (0366 280 4133 ext. 0366 280 4133, hkacan@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline (pretest) and immediately after the six-week intervention (posttest) (time frame: Baseline (pretest) and immediately after the six-week intervention (posttest)). 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 NCT07799389, which also lists 1 linked publication.
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 16 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.