Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02482415 |
| Other study ID # |
130121 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
June 22, 2015 |
| Last updated |
August 3, 2016 |
| Start date |
January 2013 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
August 2016 |
| Source |
Ersta Sköndal University College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Sweden: Central Ethical Review BoardSweden: The National Board of Health and WelfareSweden: Swedish Data Inspection Board |
| Study type |
Interventional
|
Clinical Trial Summary
Health care systems are increasingly using outpatient care for patients with advanced cancer
disease with complex needs, limited life expectancy, and need for palliative care. Family
caregivers are centrally important, but are often insufficiently prepared for the caregiving
role, and experience psychological distress and physical symptoms. We hypothesize that a
psycho-educational intervention during ongoing palliative care will support family
caregivers' wellbeing and decrease negative consequences of caregiving.
The intervention, which has been developed in steps through a series of studies based on
theoretical, methodological, and empirical work, was delivered in a group format 2013-2014.
Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each
meeting had a specific topic presented by a member of the palliative care team (physician,
nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with
the participants.
The overall aim of this ongoing project is to investigate short and long-term effects of the
intervention delivered by health professionals at ten specialized palliative home care
units. Multiple methods are now being used, including a randomized controlled trial (RCT).
In total, 270 family caregivers have been requested to answer a questionnaire at four time
points: at baseline, upon completion and again 2 months after completion of the
intervention, and 6 months after the patient's death. The primary outcome variable is
preparedness for caregiving, and the secondary outcome variables cover aspects of wellbeing
including competence and reward, caregiver burden, health, anxiety and depressive symptoms,
and grief. These data will be complemented with interviews.
The project has the potential to contribute knowledge about the development of support for
family caregivers, not only in specialized palliative care but also in other contexts such
as elderly care and general home care services.
Description:
Specific aims are to:
I) Determine the effects of the intervention upon completion, in relation to preparedness
for caregiving, competence for caregiving, reward of II) Determine the effects of the
intervention in a 2-month follow-up, in relation to preparedness for caregiving, competence
for caregiving, reward of caregiving, health, anxiety, depressive symptoms, and caregiver
burden III) Determine the effects of the intervention 6-month after the death of the
patient, in relation to the family caregiver's health, anxiety, depressive symptoms and
grief IV) Identify characteristics of family caregivers who do not respond to the
intervention and describe support needs for these individuals V) Investigate associations
between preparedness for caregiving (main outcome) and competence for caregiving, reward of
caregiving, health, anxiety, depressive symptoms, caregiver burden and grief (secondary
outcomes) VI) Evaluate intervention processes from the perspective of family caregivers and
health care professionals VII) Investigate the influences of the caregiver intervention, for
the patients with advanced cancer disease
A psycho-educational intervention was developed based on the theoretical framework of
Andershed and Ternestedt relating to the principal support needs of family caregivers. The
framework describes family caregivers' involvement in caregiving, and focuses on knowing,
being and doing. Knowing is considered crucial for family caregivers, and is connected to an
awareness of the nature of the caregiving role: knowing what to expect and what to do. Being
is related to the management of one's own emotions and those of one's relative. Doing covers
the practical care acts including a range of activities. It is assumed that insight will
increase family caregivers' possibilities for making choices and for their involvement in
caregiving.
The aim of the intervention is to increase family caregivers' feelings of preparedness for
caregiving, to support their wellbeing, and to decrease negative consequences associated
with caregiving. Preparedness refers to how ready family caregivers perceive they are for
the tasks and demands of the caregiving role, such as providing physical care, providing
emotional support and dealing with the stress of caregiving. It is suggested that
preparedness could support wellbeing and protect against negative consequences in relation
to caregiving. The intervention is delivered as a programme in a group format and its
components, design, acceptability, feasibility and potential effects have been confirmed in
a series of previous studies. During the development process, slight modifications
concerning the content and structure have been done based on participant experiences.
Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each
meeting had a specific topic presented by a health care professional of the palliative care
team (physician, nurse and social worker). The meetings addressed multi-dimensional issues
in dialogue with the participants. A nurse acted as group leader and participated in all
meetings. The intervention included both supportive and educational components. Each meeting
began with a presentation based on a specific topic (palliative care, practical care and
emotional reactions). This was followed by reflection and conversation, and finally a
relaxation exercise
The intervention was conducted at ten specialized palliative home care units in the Greater
Stockholm area. These settings provide palliative care mainly for patients with advanced
cancer disease and complex needs and limited survival expectancy. The needs of the patients
include symptom management, emotional and spiritual support, and assistance with personal
nursing care.
All settings delivered 24-hours-a-day services and were staffed by multi-professional teams
including physicians, nurses, social workers, occupational therapists and physiotherapists.
The intervention was delivered altogether 21 times during 2013 and 2014. To ensure
consistency, the content and structure of the intervention followed a manual that was
developed in collaboration between researchers and staff. In order to strengthen this
consistency, all team members involved in delivering the intervention participated in a
1-day workshop covering the theoretical basis of the intervention and how it should be
conducted. In addition, several meetings between researchers and health care professionals
were held pre-intervention, and during and after the intervention. The researchers also
arranged meetings to give health care professionals from the various settings a chance to
meet and share experiences related to delivering the intervention.
Both patients and family caregivers were included in the study. The inclusion criteria for
patients were: being in receipt of palliative care, and having a limited life expectancy
that was nevertheless assumed to be >5 weeks. Patients were not included in active data
collection, but were asked to consent to the use of specific information from their medical
record, including diagnosis and illness duration. Patients were also asked for approval for
and preferences of which family caregiver(s) were to be asked to participate in the study.
The inclusion criteria for family caregivers were: being ≥18 years old, and being able to
understand and speak Swedish. All participants were consecutively approached by health care
professionals and received written study information from the researchers. Family caregivers
who agreed to participate were randomized to either the intervention or a control group
(i.e. standard care).
In total, 270 family caregivers have been included and have been requested to answer a
questionnaire to determine the effects of the intervention at four time points: at baseline,
upon completion, 2 month after completion of the intervention and 6 months after the
patient's death.
Inclusion and baseline assessment was completed in March 2014 with an end of intervention
delivery in April 2014. The 2-month follow-up assessments for these participants were
completed in June 2014. The long-term assessment may be extended since its timing is
dependent on the time of death of the patient. All data collection will, however, be
finalized by December 2015. Data has been collected from family caregivers, patients and
health care professionals in order to evaluate the intervention and its influences as well
as intervention delivery
To determine the effects of the intervention, participant assessments are made at four time
points: before randomization (i.e. at baseline), upon completion of the intervention, 2
months after the intervention and 6 months after the patient's death
The questionnaire includes background characteristics such as age, sex, living conditions,
level of education, relationship with the patient, marital status, financial situation,
morbidity, and health care needs. It also includes scales with documented validity and
reliability. The primary outcome variable is measured using the Preparedness for Caregiving
Scale (PCS). The secondary outcome variables are measured using the Caregiver Competence
Scale (CCS), Reward of Caregiving Scale (RCS), Caregiver Burden Scale (CBS), Health Index
(HI), and Hospital Anxiety and Depression Scale (HADS). Social support is measured using the
Multidimensional Scale of Perceived Social Support (MSPSS), grief is measured using the
Anticipatory Grief Scale (AGS) & Texas Revised Inventory of Grief (TRIG)), and background
data are assessed to identify characteristics for family caregivers who will not respond to
the intervention
Interviews have been conducted with the aim to evaluate intervention processes from the
perspective of family caregivers and describe influences for patients. With the aim of
describing the need for support among family caregivers who do not respond to the
intervention, interviews are being planned. Focus group interviews have been conducted with
the aim to evaluate the intervention processes from the perspective of care professionals.
The number of participants for experiential explorative studies were based on sampling
principles for qualitative methods and included: 19 interviews with family caregivers 25
Health care professionals. Approximately 20 interviews with family caregivers who do not
respond to the intervention will be held.
Data analysis To secure the statistical power for the regression analyses, sample size
calculations were made. A sample of 110 would be sufficiently large to detect a medium
effect size.
Descriptive statistics, χ2 statistics for categorical variables, and Student's t-test
(unpaired) for continuous data (or equivalent non-parametric tests) were used to describe
the characteristics of the participants and to compare the intervention and control group at
baseline. Due to violations of the assumption of independence multiple linear regression
analysis based on robust variance estimates was conducted to test the short and longer-term
effects of the intervention (at baseline, upon completion of the intervention and two months
following the intervention) and 6 months after the patient's death.
Participants from the intervention group will be categorized into those who demonstrate
improvement and those who do not and descriptive statistics will be used to identify
characteristics associated with this distinction. Age, sex, living conditions, educational
level, relation to the patient, marital status, financial situation, morbidity, health care
needs, social support, and anticipatory grief will be included as predictor variables.
Multiple linear regression analyses will be used to investigate the association between
study outcome variables.
Analyses of interviews and focus group data were conducted with interpretive descriptive
analysis during data Collection.
Ethical considerations A guiding ethical principle is not to harm the study participants,
whether they participate in the intervention or in the control group. We have considered
that answering the questionnaire and participating in the interviews may be associated with
strong emotions. In addition, we have considered the stressful situation for caregivers. For
this reason, the written and oral information emphasizes the voluntary nature of
participation and the right to withdraw from the study at any time point. Ethics approval
for the project and the extended project has been obtained from the regional ethical review
board in Stockholm (2012/377-31, 2012/2191-32, 2013/934-32).
Significance and clinical relevance The Project is based on an RCT design contributing to
high evidence value results. It was hypothesized that a psycho-educational intervention
delivered by health care professionals during ongoing palliative care would support family
caregivers of patients with advanced cancer disease, sustain their wellbeing and decrease
the negative consequences of caregiving. The project will expand the knowledge about short
and long-term effects as well as intervention processes and influences of the intervention
from the perspective of family caregivers, health care professionals and patients. The
studies can thereby prepare for implementing the intervention in clinical settings. The
intervention was planned, designed and conducted in cooperation with the health care
professionals who were responsible for its delivery at ten specialized palliative home care
units. This will further facilitate implementation of the intervention and research results
- not only at the study settings, but also at other specialized palliative home care units.
The RCT design should enhance the generalizability of the results and make the intervention
applicable to implement as a tool in clinical practice. The project also has the potential
to generate results that will contribute to the development of support for family caregivers
in other contexts, for example elderly care and general home care services. Overall, the
project has a potential to contribute to the body of knowledge about intervention
development, delivery, and evaluation during ongoing palliative care.
