Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03493906 |
| Other study ID # |
Rigshospitalet PAS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
September 1, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Acute leukemia is a life threatening hematological malignancy which can result in
substantial symptom burden including impaired psychological wellbeing. Peer-to-peer support
has positive and beneficial effects on patients with cancer. Yet there is lack of knowledge
and evidence of the feasibility and the effect of peer-to-peer support on patient with acute
leukemia
Aims: The study aim to examine the feasibility and safety of Patient Ambassador Support in
newly diagnosed patients with acute leukemia during treatment, and to examine the benefit on
symptoms and psychological wellbeing in both patients and ambassadors.
Design and methods: This study is a one arm feasibility intervention trial with patients
n=40; patient ambassadors (PA) n=30. Patients will be consecutively recruited at the
Departments of Hematology, Rigshospitalet, Herlev and Gentofte Hospital and Sjællands
Universitetshospital, Roskilde, and paired with a PA who will follow and assist the patient
over the course of two series of chemotherapy for a 12 week period, with one follow-up
contact at 3 month. Data is collected at baseline (within 2 weeks of diagnosis), post
intervention (12 weeks) and follow-up 6 months.
Implication: This study has the potential to be a new model for care incorporated in the
oncology/hematology clinical care setting, creating an active partnership between patients
and former patients; and in collaboration with the health care professionals which may
strengthen the existing care and support system.
Description:
Study Part 2 Aim To investigate the feasibility and safety of Patient Ambassador Support
(PAS) and whether there is benefit on psychological wellbeing and symptoms among newly
diagnosed patients with acute leukemia and among former patients with acute leukemia (patient
ambassadors).
Design and Methods A one arm feasibility intervention trial with patients (n=40) and patient
ambassadors (PA) (n=30).
Recruitment Patients will be recruited at three Danish hematology departments: Rigshospitalet
(RH), Herlev og Gentofte Hospital (HGH and Sjællands Universitetshospital, Roskilde (SUR),
from January 2018 to June 2019. Eligible patients receive oral and written project
information from KHN within two weeks from diagnosis. KHN provides a summary of the study and
gives the opportunity to raise questions or concerns related to the study.
PA´s will be recruited voluntarily from the patient association LyLe and from the outpatient
hematology departments of RH, HGH and SUR by KHN, and screened by interview to assess their
appropriateness for the intervention. Screening interviews include questions about a
survivor´s motivation for volunteering, availability, ability to respect confidentiality, and
ability to acknowledge the vulnerability that may occur when they revisiting experience of
others with acute leukemia. The PA is obligated to sign a confidentiality commitment, and
knows and accepts the terms and requirements included in the intervention. Furthermore, the
PA provides information regarding age, gender, diagnose, treatment, interests, work,
education, social conditions in order to match with patients. The PA must provide
transportation themselves but will receive a monetary incentive for their participation.
During the intervention we will adjust the PA recruitment process in order to fill specific
needs in the program such as age groups or diagnosis. This will ensure that we do not have a
larger ambassador pool than we effectively utilize.
Patients and ambassadors who have consented and agreed to participate in the study will
complete the baseline testing (patient reported outcome questionnaires) before the beginning
of intervention.
Patient ambassador training program Recruited PAs will receive a group training program,
curriculum and an ambassador 'checklist´. Before interacting with patients, the PA will
receive 6 hours of training. The training will be organized by KHN and a project nurse from
each intervention site. The training will be carried out by KHN, the project nurse, a
represent from the PAB and a psychologist. Training modules include information on medical
facts related to acute leukemia, information on psychosocial issues, training in
communication skills with emphasis on active listening, and learning how to help other
patients problem- solve and advocate for themselves within the health care system. Training
also includes discussion of the PA ´s personal goals and concerns about volunteering in the
study and their individual attitudes toward survivorship and illness. The importance of
maintaining appropriate boundaries are discussed, to ensure PA do not overly identify with
patients and remain aware of their role as listening mentors who use their experience only
when solicited by the patient. Further, possible changes in medical conditions in both
themselves and the patients will be discussed. The PA is offered supervision during the
intervention and the opportunity to attend ambassador support meetings every second month for
ongoing education and to process their experiences with patients.
Match between patients and ambassadors Patients and ambassadors express prior to intervention
which preferences they have for their match. They will be matched according to diagnosis,
age, gender and other factors that might create a mutual understanding and ease of
communication. KHN will pair patients with a PA. If it is not possible to match on the given
preferences, the patient and ambassador will be involved in the decision.
PAS intervention The intervention consists of support provided by the PA, who will follow and
assist the patient over the course of 12 weeks, through two series of chemotherapy. The
intervention consists of minimum four face-to-face meetings between patient and PA and
additionally open telephone and/or email contact based on the patients 'individual needs,
including one follow-up contact at 3 months by telephone. The duration of the contact is
individual. The context of the face-to-face meetings are chosen between patients and
ambassadors e.g. café on the local hospital, a café near both patient and ambassador or
private based on the contact developed between patient and ambassador. The PA will follow one
patient at a time, however at the end of the 12 week period; the PA can choose to follow a
new patient. During the first meeting, an expectation agreement between the patient and PA
will be discussed and signed. The PA will use an ambassador checklist to document the
frequency, content and quality of the connections between patient and PA, as well as
documenting themes, goals, progress and outcomes of their conversations. The checklist will
be developed in conjunction with representatives from the PAB and prior to the recruitment of
the IG. The checklist will provide a comprehensive guidance and list of important and
relevant actions, or steps to be taken in the role as PA, as well as serve as a work and
documentation tool during the intervention and follow-period. Upon completion of the training
program each PA will receive a training certificate and a personal PA name badge.
Changes in medical conditions in both patients and ambassadors which will affect their
ability to participate in the study will result in exclusion. The project nurse at the
specific hematologic department reports to the primary investigator (KHN) within 48 hours.
Changes in medical conditions comprise the following conditions: relapse (ambassadors),
critical psychological conditions including delirium or severe depression, hospitalization in
intensive care unit (ICU) longer than two weeks or transition to palliative care.
Safety net - ambassadors' support There will be held an ambassador support meeting which is
important to allow the ambassadors to share experiences, solve problems, and provide mutual
support. The ambassadors have the possibility to request supervision from a psychologist
during the intervention. The psychological health of the ambassadors is of great interest and
it is important that they do not suffer unnecessary distress following the intervention. Any
adverse events will be documented and acted on.
Outcomes measurements and data collection Data are collected by patient reported outcome
measures (PROM) completed by patients electronically prior to intervention, post intervention
(12 weeks) and at 3-month follow-up. PROM is completed by PA, after they have completed the
patient ambassador training program, but prior to their first PAS intervention and at post
intervention (12 weeks). Socio-demographic characteristics are collected through by patient's
medical charts and questionnaire.
