Psycho-oncology on wheels—a qualitative feasibility study of implementing home-based psychosocial support within specialist palliative home care (SPHC): a study protocol
Introduction
Background
Psychological distress is common among cancer patients, with prevalence being especially high within specialist palliative care settings. This heightened distress in patients nearing the end of life can be attributed to various factors, such as increased physical symptoms and pain, fear of death, existential anguish, emotional distress from role loss, and anticipatory grief (1). Depression and anxiety disorders are frequently observed in this patient group, yet they often go unrecognized and undertreated, which significantly diminishes the patient’s quality of life and causes considerable distress for both the patient and their family (2-4). Psycho-oncological support aims to help cancer patients and relatives with managing psychosocial distress in various ways, for example, by mobilizing and expanding available resources, strengthening self-esteem, acknowledging life achievements, reducing feelings of loneliness, facilitating communication about death and grief, maintaining a sense of purpose and hope, and promoting adaptive coping with their illness (5,6). A range of interventions is used to address the patients’ and/or relatives’ needs, such as psychosocial counselling and psychotherapy (in individual or group setting), psychoeducation, stress management training, relaxation techniques, crisis intervention, special psycho-oncological procedures in palliative care [such as “Managing Cancer and Living Meaningfully” (CALM) or dignity-centred therapy], e-health applications, art therapies, psychopharmacological treatment or occupational therapy (7).
The effectiveness of psychosocial interventions on diverse domains of quality of life in patients with advanced cancer has been demonstrated in various studies (8,9). The beneficial effects of psycho-oncological interventions are observed not only in the emotional, but also physical dimensions such as pain, and pertain not only to the patients themselves, but also their relatives involved in their care (family carers, informal caregivers) (10,11).
Psycho-oncological support addressing the burdens of palliative patients and their families should be embedded in an interdisciplinary and multi-professional care concept (12) and enable a sustainable, long-term therapeutic relationship. Such therapeutic consistency requires continuation and ongoing care that extends beyond the inpatient setting and into post-discharge outpatient treatment. In the context of tumour therapy, this therapeutic consistency can usually be maintained through psycho-oncological consultations during regularly scheduled outpatient or inpatient appointments.
Rationale and knowledge gap
A decline in general condition of the patient with the cessation of tumour-specific treatment often leads to an abrupt end of the established psycho-oncological therapeutic relationship. This situation frequently results from structural limitations, given that patients experiencing such a decline in health are typically no longer capable of traveling or being transported to the oncology centres and costs for transportation are not reimbursed (13). The loss of contact and lack of access to psycho-oncological care is all the more serious, as the moment of termination of tumour therapy is experienced by many patients and relatives as an existential crisis (14). Relatives sometimes experience levels of distress equal to or even exceeding those of the patients, which can be associated with negative effects on their health and increased mortality (15-18).
In this context, specialist palliative home care (SPHC) gains enhanced significance. According to paragraph 37b of Volume V of the German Social Insurance Code (SGB V), health insurance holders facing an incurable, progressive illness and limited life expectancy are entitled to SPHC (§ 37b, Section 1, SGB V). In particularly complex and stressful situations for patients with life-limiting illnesses, SPHC provides multi-professional, 24/7 on-site support for patients and their relatives in home, inpatient and hospice settings, going beyond the existing general practitioner’s or oncologist’s care, general nursing care and family support. This ensures continuity of comprehensive palliative care, bridging the gap between inpatient and outpatient care.
The guidelines of the Federal Joint Committee on the prescription of SPHC of 20th December 2007 emphasize in particular the core medical and nursing services, while psychosocial support is described more in the context of the coordination tasks of SPHC (19). As a result, the vast majority of existing SPHC contracts (for example, in Baden-Württemberg) finance home visits by physicians and nurses, but not home visits by psycho-oncology staff (20). SPHC is therefore—despite the genuinely multi-professional character of palliative medicine—in fact only a bi-professional care structure.
Objective
Within the “Psycho-oncology on Wheels” project, palliative cancer patients and their relatives are given the opportunity to continue psycho-oncological care in their home environment, aided by SPHC. The objective of the study is to investigate the feasibility of providing psycho-oncological care to palliative patients and their relatives in a home-based environment, utilizing the infrastructure of the SPHC. To determine feasibility, we will examine the acceptability and satisfaction with the intervention among patients and their relatives. Furthermore, we will evaluate its practicability from the perspective of healthcare professionals, considering, for example, logistical aspects such as scheduling and organization. Our study aims to identify both the facilitators and barriers that influence the successful implementation of the intervention in the home-based setting. We present this article in accordance with the SPIRIT reporting checklist (available at https://apm.amegroups.com/article/view/10.21037/apm-25-70/rc).
Methods
Study design and setting
This is a monocentric, prospective, unblinded, non-randomized feasibility study using qualitative methods (interviews). When participating in the study, at least one appointment for psycho-oncological care takes place in the home setting of the patients and their relatives. Further appointments are arranged according to the individual needs of the study participants. The structuring of the conversation in the home setting is at the discretion of the psycho-oncologists who perform the home visits. No specific form of therapy is prescribed. Instead, the support is tailored to the individual needs of the patients and their relatives. Participants can discontinue their involvement or decline further appointments at any time based on their own request. Additionally, participation may be discontinued if there are significant changes in a patient’s needs or medical condition that make continued involvement unsuitable or burdensome. Both the SPHC team and the psycho-oncologists are part of the medical staff at Heidelberg University Hospital in Germany. The SPHC team provides home-based care for patients in Heidelberg and the Rhein-Neckar district. The psycho-oncological care at home for patients and their relatives participating in the study will be carried out by the staff of the psycho-oncology department, using the infrastructure of the SPHC. The establishment of joint meetings is intended to promote communication between the two departments. The project has a duration of one year, and the Gantt chart (as presented in Figure 1) illustrates the key milestones, work packages, and their associated timeline.
Recruitment
To investigate the experiences of providing psycho-oncological care at home from various perspectives, different target groups will be interviewed: patients and their relatives, members of the SPHC team, and the psycho-oncologists who conducted the home visits.
Patients and their relatives are recruited by qualified healthcare professionals from the SPHC team and the psycho-oncology department. The SPHC team members recruit participants by assessing their need for psychosocial support during home visits. Meanwhile, psycho-oncologists recruit patients and relatives who are already receiving care, as their need for support is pre-established. During the initial contact, these healthcare professionals inform potential participants about the psycho-oncological support offered within the project and provide informational flyers. Following this, interested individuals have a personal conversation with a member of the study team and receive an information leaflet to learn detailed information about the study’s goals, procedures, benefits, and risks.
Members of the SPHC team and the psycho-oncologists who conducted the psycho-oncological home visits will be personally approached by the study team and invited to participate in a qualitative interview. While they provided patient care in the context of their work, their involvement as research participants, however, is based on personal, voluntary consent, as with all other participants. A patient representative will be recruited through personal contact by the study team to gain another valuable perspective on potential barriers and facilitating factors.
Study participants
To answer the research questions, this study will collect qualitative data from patients and their relatives receiving at-home psycho-oncological care, as well as from psycho-oncologists, SPHC staff, and a patient representative.
Patients and relatives who meet the following criteria will be included:
- Age ≥18 years.
- Capacity to consent.
- Cancer patients who are treated with palliative intent and their relatives.
- Received psycho-oncological care before.
Exclusion criteria for patients and relatives:
- Patients who, at the discretion of the treating physician (SPHC team), are in too poor general condition or too burdened to participate in a study of any kind and their relatives.
- Patients or relatives with cognitive or communicative deficits.
- Patients with a life expectancy of a few days and their relatives.
Inclusion criteria for SPHC staff:
- Age ≥18 years.
- Capacity to give consent.
- Care of palliative cancer patients and their relatives.
Inclusion criteria for psycho-oncologists:
- Age ≥18 years.
- Capacity to give consent.
- Provided home-based psycho-oncological care for palliative cancer patients and their relatives.
Inclusion criteria for the patient representative:
- Age ≥18 years.
- Capacity to give consent.
- Providing consultation for research projects.
Exclusion criteria for SPHC staff, psycho-oncologists and the patient representative:
- Cognitive or communicative deficits.
The final determination for patient criteria regarding general condition, cognitive or communicative deficits, and capacity to give consent will be at the discretion of the treating physician (SPHC team) or psycho-oncologist. Cognitive or communicative deficits refer to a person’s inability to understand the study content or actively participate in conversations. Capacity to give consent is based on the patient’s ability to comprehend the study’s purpose and risks, and to make and clearly communicate a conscious decision.
Sample size calculation
This exploratory study involves a vulnerable study population. The final sample size is determined using the “information power” model, which consists of a number of methodological principles. In summary, the main message of this approach is: the greater the information content of the sample, the lower N [the number of interviewees] and vice versa. Accordingly, the following five dimensions have an influence on the sample size: (I) the aim of the study; (II) the specificity of the sample; (III) the use of an already established theory versus the development of a new theory from the data; (IV) the competence of the interviewer(s); and (V) the method of analysis (21). Following this model, a sample of 30 interviewees (patients/relatives) and 11 interviewees (SPHC team members/psycho-oncologists/patient representatives) could be sufficient for this study. A systematic review of interview studies within qualitative health research identified median sample sizes ranging from 15 to 31 interviews across various journals (22). Our target sample size of 30 interviews with patients/relatives therefore aligns with common practice, providing an empirically supported and practical guideline. Continuous assessment of information power can also avoid wasting time and resources on collecting and analysing data that does not serve the purpose of the study (21).
Data collection
A multi-perspective approach will be taken to investigate the feasibility of home-based psycho-oncological care. The following target groups will be interviewed: palliative cancer patients and their relatives, members of the SPHC team, and the psycho-oncologists who conduct the home visits. To minimize the burden on patients and their relatives, their interviews will be conducted in their homes, while interviews with SPHC staff and psycho-oncologists will be held at the university hospital. The approximate duration of the interviews for all target groups is 20 to 30 minutes. All semi-structured interview guides for each target group (patients, relatives, SPHC team, psycho-oncologists) address the following topics: experiences with the home-based psycho-oncological care, including both positive and negative aspects. The guides also cover the perceived differences between home visits and clinic-based appointments, as well as logistical and organizational aspects. Lastly, the questions seek to identify the facilitating factors, challenges, and barriers to the long-term implementation of the intervention. In addition to the topics mentioned, the interview guides are tailored to each specific participant group to gain in-depth insights. Patients will be asked about their prior experiences with psycho-oncology and their wishes for care. Furthermore, both psycho-oncologists and SPHC staff will be asked about their collaboration and communication between the two departments. Specifically, psycho-oncologists will be asked about the differences in the preparation and delivery of care when compared to their routine work.
The interviews with patients and relatives are conducted after the first appointment with the psycho-oncologist at the earliest and after the last appointment with the psycho-oncologist at the latest. This timeframe accommodates the patient’s autonomy in determining the number of sessions. The interviews with the SPHC staff and the psycho-oncologists were conducted during the same period (see Figure 1).
Additionally, socio-demographic data will be collected via a questionnaire to characterize the study population. To spare patients from having to repeatedly provide potentially distressing information about their illness, relevant data will be retrieved directly from their medical records (for example, information about the palliative intent of their treatment).
Data analysis plan
Following transcription, the interviews will be analysed by the Department for Palliative Medicine at University Hospital Heidelberg using the qualitative data analysis software MAXQDA. Qualitative content analysis according to Kuckartz is the primary analytical method and the material will be analysed with regard to specific aspects related to the research question. Categories will be developed using a mixed deductive-inductive approach, incorporating strategies of open coding and summarization. Intercoder reliability will be checked by a second researcher to ensure quality and establish intersubjectivity (23,24). All study-relevant data will be stored in pseudonymized form, ensuring protection against unauthorized access. Only members of the study team will have access to this data. Pseudonymization keys will be destroyed at the latest three months after the completion of data collection for each participant, consequently ensuring the complete anonymization of the data. Data collected during the study will be retained anonymously in accordance with good scientific practice for ten years after the study’s end.
Registration and ethical approval
The feasibility study was registered with the German Clinical Trials Register (ID: DRKS00034896) and has received approval from the Ethics Committee of the Medical Faculty of Heidelberg University (No. S 382/2024). The study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Participation of patients and other persons is voluntary and can be revoked at any time without any disadvantages for the persons concerned. The participating persons will be informed of this in the information leaflet. Prior to enrolment all participants will receive written and verbal information about the nature and scope of the planned study from a member of the study team, in particular about the possible benefits for their health and possible risks. No risks associated with study participation are anticipated. However, participants are assured that they can contact the study team for assistance and support if they encounter any unforeseen challenges or concerns. Their consent is documented by signing the informed consent form. In the event of withdrawal from the study, any (data) material already obtained will be destroyed or the study participant will be asked whether he/she agree to the analysis of the material. The names of the study participants and all other confidential information are subject to medical confidentiality and the provisions of the General Data Protection Regulation, as well as the state and federal data protection laws (LDSG (Landesdatenschutzgesetz) and BDSG (Bundesdatenschutzgesetz), respectively).
Discussion
Psycho-oncological support is important for palliative cancer patients and their relatives, helping them manage emotional distress and cope with the psychological burden of cancer (12,25-27). A nationwide analysis in Germany from 2018 (13) indicates that outpatient psycho-oncology services are primarily provided in psychosocial cancer counselling centres, by medical and psychological psychotherapists, in psycho-oncological outpatient clinics of hospitals and certified cancer centres, as well as in specialised oncological practices. However, these findings also reveal an insufficient intensity of care in the outpatient sector (13). Furthermore, there are significant barriers to accessing outpatient psycho-oncology services (28), especially for the vulnerable group of palliative cancer patients in the home environment. These barriers include a lack of information about available service, stigma surrounding psycho-oncology or negative attitudes and transportation difficulties (28). There is a need to further develop interdisciplinary care models to provide needs-based psycho-oncological care for patients in the outpatient setting (12,13,29,30) and to address the described challenges. The project “Psycho-oncology on Wheels” implements psycho-oncological home visits, specifically targeting transportation-related difficulties. This approach seeks to bridge existing gaps in care, ensuring that palliative cancer patients and their relatives have low-threshold access to psycho-oncological support. It thereby promotes more comprehensive and continuous psychotherapeutic and psycho-oncological co-care that can extend beyond the point when patients with advanced cancer are no longer able to attend hospitals, outpatient clinics, or psychotherapeutic practices.
Although the involvement of psychologists in SPHC is considered beneficial (31) and the need for psycho-oncological support for palliative patients and their relatives is described in the literature (12), these services are currently not inherently integrated into SPHC and remain unreimbursed (13). Psycho-oncological care offered by SPHC teams in Germany is often funded by donations or support organisations and there is currently no evidence of its feasibility (32,33).
This study intends to investigate this issue by identifying facilitating and hindering factors in the implementation of psycho-oncological home visits. One potential barrier could be the concerns from patients and their relatives regarding privacy within their homes. Research indicates that the perception of privacy and autonomy can be altered when healthcare professionals enter a patient’s home (34,35). Maintaining confidentiality during home visits, particularly with the potential presence of other household members, and ensuring secure data handling may be more complex compared to controlled clinical settings. To address this, it could be helpful to clarify in advance with the patient and family who will be present during the visit and how to maintain privacy during conversations. Further potential challenges for the implementation of home-based psycho-oncological support warrant careful consideration. Logistical challenges could arise regarding the scheduling of SPHC staff visits and psycho-oncologist appointments. Delays or service gaps could occur if the capacity of SPHC staff to perform home visits does not align with the availability of psycho-oncologists. Therefore, effective coordination and communication between both departments are essential for scheduling. On a therapeutic level, the shift from clinic-based to home-based sessions could disrupt existing therapeutic relationships if different psycho-oncologists are involved. Nevertheless, maintaining support through an alternative psycho-oncologist is likely to be more beneficial than having no psycho-oncological care at all. Another potential challenge is the increased burden on patients and their relatives due to the physical and emotional strain of organizing and participating in home visits. Therefore, the scheduling, frequency and duration of visits must be tailored to the individual needs and energy levels of the patients and their families.
Despite these potential challenges, the study design has notable strengths. Utilizing existing SPHC infrastructure facilitates the delivery of psychosocial care in the patient’s own home, ensuring that palliative patients receive support in a familiar and comfortable environment and promoting comprehensive care. The established access to patients and relatives by palliative care team members (36) and treating psycho-oncologists could prove beneficial for the implementation of psycho-oncological home visits and represents a significant strength of the study. Given that the potential study participants have already received psycho-oncological care, it can be assumed that stigmatization and negative attitudes towards psycho-oncology will play a minor role in this target group. Additionally, this interdisciplinary care model offers an opportunity for knowledge transfer and skill-sharing between the psycho-oncology providers and the broader multidisciplinary team. The qualitative design of the study offers valuable insights into the real-world feasibility of implementing home-based psycho-oncological care. Through semi-structured interviews with patients, relatives, psycho-oncologists, and SPHC staff, the study will explore various perspectives on the challenges and opportunities of integrating psycho-oncological services into SPHC.
The study’s findings are expected to directly inform structural policy discussions on home-based palliative care even in federal legislation and on access to psychotherapeutic/psycho-oncological support, thus improving the care for cancer patients and their relatives.
Acknowledgments
We would like to thank Susanne Molter, Janine Damaske, and Tabea Bertram from the Department of General Internal Medicine and Psychosomatics and the SPHC team from the Department of Palliative Medicine at Heidelberg University Hospital for their valuable input in planning the intervention and discussing the procedures and logistics.
Footnote
Reporting Checklist: The authors have completed the SPIRIT reporting checklist. Available at https://apm.amegroups.com/article/view/10.21037/apm-25-70/rc
Peer Review File: Available at https://apm.amegroups.com/article/view/10.21037/apm-25-70/prf
Funding: This work was supported by
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://apm.amegroups.com/article/view/10.21037/apm-25-70/coif). All authors report that the Dietmar Hopp Foundation funded the study. The authors have no other conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (No. S 382/2024) and written informed consent will be obtained from all individual participants.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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