Bone Metastases in Subjects With Advanced Cancer, Radiotherapy
Conditions
Keywords
Palliative Care, Bone Metastases, Radiotherapy, Advanced Cancer, Quality of Life, Quality of Care
Brief summary
Rationale: With improvements in systemic tumour-directed treatments for primary tumours, survival rates for patients with bone metastases are improving. However, individual illness trajectories become less predictable and more vulnerable to adverse events from treatments, negatively impacting a patient's quality of life (QoL). Palliative care is aimed at reducing symptoms and improving QoL for patients with incurable diseases through early identification, thorough assessment, and effective management of physical, psychological, social, and spiritual challenges. Early integration of specialist palliative care into oncology care has shown to reduce symptom burden and potentially inappropriate end-of-life care, and to enhance QoL, yet it is often initiated late. Objective: The primary objective is to evaluate the satisfaction with care and QoL experienced by patients with bone metastases who are offered a consultation with the hospital palliative care consultation team (PCCT) when referred for palliative radiotherapy compared to patients who receive standard of care. Study design: A prospective, pragmatic, two-arm multicenter randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT+) cohort that follows the Trials within Cohorts (TwiCs) design. Study population: Patients with bone metastases referred for palliative radiotherapy who have their treating physician in one of the participating centers and have not been in contact with the hospital PCCT before. Intervention: A consultation with the hospital PCCT within two weeks after inclusion in PRESENT+. In the standard of care control group, no consultation with the PCCT will be scheduled. They may have a consultation during follow-up if referring physicians may consider a consultation appropriate, or when patients themselves feel they want a referral. Main study parameters/endpoints: Satisfaction with care (affective behavior) four weeks after inclusion in PRESENT+.
Interventions
BEHAVIORALPalliative Care Consult
Patients receive a regular consult (30-45 min) with the hospital palliative care consult team (PCCT) that is tailored to the preferences and needs of the individual patient. The following topics can be discussed: 1) physical symptoms, and, where appropriate, followed by recommendations for symptom management and transfer of handovers to the treating care team, 2) psychological, social and spiritual distress, followed by provision of counseling or referral to another specialist if needed, 3) goals of care to explore participants' values, preferences and needs (advance care planning), and 4) discussion about the needed follow-up of palliative care, and 5) care for caregivers. At baseline, patients receive a validated symptom questionnaire (Utrecht Symptom Diary (USD)-4D), which can be used as input for discussion during the consultation. If necessary, patients may have a follow up.
Sponsors
Roxanne Gal
Leiden University Medical Center
Radboud University Medical Center
Groene Hart Ziekenhuis
Alrijne Ziekenhuis Leiderdorp
Meander Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Patients allocated to the control arm are not aware that they are part of this trial/the control arm.
Intervention model description
The trial will be conducted according to the Trials within Cohorts (TwiCs) design. Patients who provided broad consent to participate in the prospective PRESENT bone metastases cohort study, and who are eligible to participate in TIPZO-RT, will be randomized to either the intervention or control arm. Patients allocated to the intervention arm will be informed about the intervention and asked informed to undergo the intervention, which they can accept or refuse. Patients allocated to the control arm will not be informed, and their data from the cohort will be used comparatively.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. broad informed consent for PRESENT+ (i.e., consent for filling out questionnaires at regular intervals and randomization into future intervention studies), and 2. having their treating physician in the TIPZO-RT study site (UMC Utrecht, Radboudumc or LUMC).
Exclusion criteria
1. not able to understand the objective of the study (in Dutch), 2. cognitive impairment or dementia, and 3. has been in contact with palliative care consultants of the hospital PCCT before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with care | 4 weeks after the start of radiotherapy | Satisfaction with care is measured by the EORTC PATSAT-C33 - Affective behavior scale. The 33-item questionnaire includes three sections addressing the perceived quality of care provided by doctors, nurses/radiotherapy technicians, and service/care organization. Participants are asked to rate their experience for each item on a five-point Likert scale (poor to excellent). For this study, we use the 4-item affective behavior scale from the "nurses and radiotherapy technicians" section. Instead of rating "nurses and radiotherapy technicians", we ask the participants to rate the care from "healthcare providers" in the hospital to broadly assess patient satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom burden | Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks | Symptom burden including physical, psychological, social and spiritual symptoms (Utrecht Symptom Diary (USD-)4D) |
| Pain | Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks | Pain as measured with the Brief Pain Inventory (BPI) |
| Quality of Life | Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months | QoL including physical and emotional functioning, and global QoL (EORTC QLQ-C15-PAL) and Painful Sites, Pain Characteristic, Functional Interference and Psychosocial Aspects (EORTC-QLQ-BM22) |
| Other satisfaction with care outcomes | Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months | Other satisfaction with care outcomes including information, coordination, and overall care (EORTC PATSAT-C33) |
| Overall survival | Max. two years | Overall survival with a maximum follow-up of two years |
| Palliative care utilization | Through study completion, about 2 years | Palliative care utilization: within the intervention group, we will measure the number of patients that were allocated to the intervention group and accepted referral (now or later in the disease trajectory) to the PCCT. |
Countries
Netherlands
Contacts
CONTACTRoxanne Gal, PhD
PRINCIPAL_INVESTIGATORYvette M. van der Linden
Leiden University Medical Center
PRINCIPAL_INVESTIGATORNatasja Raijmakers
Comprehensive Cancer Centre The Netherlands
PRINCIPAL_INVESTIGATORAnouk van Oss
Leiden University Medical Center
Outcome results
None listed