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Trial registered on ANZCTR


Registration number
ACTRN12614000150640
Ethics application status
Approved
Date submitted
4/02/2014
Date registered
7/02/2014
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptance and valued-living in palliative care patients, caregivers and significant others
Scientific title
Evaluating the effect of an Acceptance and Commitment Therapy self-help program on the psychological wellbeing of caregivers and significant others of palliative care patients: A randomised controlled trial
Secondary ID [1] 284002 0
Nil
Universal Trial Number (UTN)
U1111-1152-7535
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression and Prolonged Grief 291039 0
Condition category
Condition code
Mental Health 291378 291378 0 0
Depression
Mental Health 291379 291379 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a skills-based Acceptance and Commitment Therapy (ACT) self-help booklet and telephone support. The booklet is designed to help caregivers and significant others cope better with their situation through psycho-education and experiential exercises, and telephone support. The booklet will teach skills that enable participants to have a different relationship with their difficult thoughts and feelings so that they have less of a negative impact on the way they want to live their life and who they want to be. It will also guide participants to be clearer on their values and make a commitment to act in accordance with their values despite the difficulty they are experiencing. The booklet was developed based on a literature review and consultation with experts in psychology and palliative care. It has been reviewed by a consumer group of cancer caregivers.

A researcher will call participants after 1 week of receiving the booklet to offer support for understanding the information and exercises. The researcher will ask participants if they did all, some or none of the reading and exercises, and if they have a question about the information or exercises. The researcher will respond with positive and encouraging feedback, and offer advice and instruction. If the caregiver or significant other becomes bereaved within 1 week of receiving the booklet, the researcher will wait at least 2 weeks before calling. This time period was recommended by site staff and is reflective of their current practice with bereavement follow-up support.
Intervention code [1] 288693 0
Behaviour
Comparator / control treatment
The control group receives treatment as usual in the form of psychosocial support by social workers at the participating site hospital. The social work team is comprised of one full-time inpatient worker and two part-time workers in the community. Social work is offered to all patients and their family and friends, and includes psychoeducation, counselling, and practical assistance with broader social issues such as finances. As per the standards of Palliative Care Australia a bereavement service is provided, which involves an information pack to all palliative clients’ families and a follow-up phone call. Bereavement counselling is also available for those who seek it and an annual Memorial Service is facilitated by the social workers.
Control group
Active

Outcomes
Primary outcome [1] 291380 0
Acceptance (also known in the negative as experiential avoidance), measured by the Acceptance and Action Questionnaire - II
Timepoint [1] 291380 0
Pretreatment, 1 month posttreatment, 6 months postbereavement
Secondary outcome [1] 306640 0
Depression, measured by the Hospital Anxiety and Depression Scale
Timepoint [1] 306640 0
Pretreatment, 1 month posttreatment, 6 months postbereavement
Secondary outcome [2] 306642 0
Prolonged Grief, measured by the Prolonged Grief - 12 (preloss) and Prolonged Grief - 13 (postloss)
Timepoint [2] 306642 0
Pretreatment, 1 month posttreatment, 6 months postbereavement
Secondary outcome [3] 306643 0
Valued-living, measured by the Valued Living Questionnaire
Timepoint [3] 306643 0
Pretreatment, 1 month posttreatment, 6 months postbereavement

Eligibility
Key inclusion criteria
Participants need to be aged 18 years or over and have sufficient comprehension of English to be able to understand and complete the study documents. Caregivers are identified by the patient as the primary informal caregiver; that is, the person who spends most time with the patient, who provides most of their informal day-to-day care, assistance and support. Significant others are identified by the patient or caregiver as a significant other who provides informal care, assistance or support and is perceived as being substantially affected by the patient’s situation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with active psychosis, intellectual disability, moderate to severe cognitive impairment, or insufficient comprehension of English that would impair their ability to give informed consent and provide valid responses.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research and clinical staff at participating sites introduce the study and provide a study brochure to potentially eligible caregivers during their routine rounds. If a caregiver is not present with the patient, recruiting staff ask patients if they would like to nominate their caregiver to receive more information about the study. Recruiting staff always ask patients and caregivers to nominate any significant other(s) who they believe might be willing to receive more information about the study. Results of recruitment discussions (i.e. accept or decline to receive more information about the study and nominations) are recorded on a recruitment form to be emailed to the research team.

The research team post nominated caregivers and significant others a recruitment package containing a letter from the managing director of the service and a study brochure. The letter describes how their name was obtained, the identity of the researchers, and an outline of the aims and procedures. The letter also informs caregivers and significant others that should they wish to participate they can contact the research team using the details provided.

A researcher attends the inpatient unit once to twice a week to explain further about the study and answer any questions to potential participants who have expressed interest. The researcher then provides caregivers and significant others with a pre-randomised study package containing a participant information sheet and consent form, baseline questionnaire, reply paid envelope and, for intervention participants, the booklet. Potential participants absent from the inpatient unit are posted the study package.

Randomisation will be performed by an individual blinded to the identity of participants, using computer-generated random numbers. Randomisation will be stratified by social network such that caregivers and significant others from the same social network will be allocated to the same group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated using Microsoft Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is acceptance scores between the caregiver treatment and control groups as measured by the Acceptance and Action Questionnaire - II at 1 month post-bereavement. Assuming a significance level of .05, 176 participants per condition gives an 80% chance of detecting a small effect size of 0.3. To account for caregiver drop out of 30% as seen in similar studies, we inflate this to 230.

The inpatient unit at Port Kembla Hospital contains 15 beds and has an average turnover of 2 weeks, and therefore approximately 390 patients in 12 months. At any one time, approximately 75% of patients are too unwell or cognitively impaired to be eligible for participation, which suggests a potentially eligible population of 98 in 12 months. Previous cross-sectional survey studies inclusive of an inpatient population show response rates of at least 50%. There are approximately 5 palliative patients moving through Wollongong Hospital every week and hence approximately 200 patients over a 10-month data collection period. If we estimate a response rate of 40% it is feasible to achieve a sample size of 80 patients over a 24-month data collection period at Port Kembla Hospital and 20 patients over a 10-month data collection period at Wollongong Hospital.

Similar intervention or longitudinal studies with caregivers indicate that a 70% response rate is a reasonable expectation. No previous quantitative studies in palliative care have purposefully recruited significant others and we therefore cannot make an informed estimate of their response rate. However, assuming each patient has at least one significant other, we anticipate an equivalent response rate to caregivers. Therefore, since caregiver and significant other participation is independent of patient participation, it is feasible to achieve a sample size of 340 caregivers and 340 significant others over a 15-month data collection period at Port Kembla Hospital and 120 caregivers and 120 significant others over a 6-month data collection period at Wollongong Hospital.

ANALYSIS
Descriptive statistics and graphic representations will be used to summarize participant’s demographic details and scores on the outcome and process variables. Tests will be two-tailed. The experiment wise error rate for contrast analyses will be controlled using the Bonferroni procedure, with the resulting significance value set at a=0.025. For all other analyses, statistical significance will be set at a=0.05.

Exploratory hierarchical multiple regressions analyses (MRA) will be conducted separately on preintervention data for acceptance and valued-living as independent variables on levels of depression, grief, death attitudes and communication as dependent variables; adjusted for age, gender and disease. Planned contrast analysis to test differences between caregivers and significant others will be [1 -1].

Hierarchical MRA will be the primary analytic method used to investigate the efficacy of the intervention on levels of acceptance and valued-living. The predictor variables will be: demographics (age, gender and disease), condition (intervention vs control), time (baseline vs 1 month follow-up vs 6 month postbereavement follow-up). Condition and time will be dummy coded. Hierarchical MRA with follow-up simple slope analyses will also be used to investigate the efficacy of the intervention on levels of depression and grief. In particular, the effect of condition across assessment points as a function of levels of acceptance and valued-living will be explored. The predictor variables will be: demographics (age, gender and disease), condition (intervention vs control), time (baseline vs 1 month follow-up vs 6 month postbereavement follow-up), acceptance, valued-living, and four interaction terms between the condition comparison and acceptance or valued-living variables. Condition and time will be dummy coded, and acceptance and valued-living will be mean-corrected. Mediation of the intervention effects by acceptance and valued-living will be tested by bootstrapping analysis.

The MRAs will be conducted using both intent-to-treat and per-protocol analysis. The intent-to-treat analysis will give an unbiased estimate of treatment effect resulting from removal of noncompliants and dropouts, whereas the per-protocol analysis will give a less diluted estimate of intervention effects. In the per-protocol analysis intervention participants will be excluded if they had not completed at least 75% of the booklet.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The time allowed for recruitment and follow-up was constrained to fit within the timeframe of a PhD project.
Date of first participant enrolment
Anticipated
3/03/2014
Actual
31/03/2014
Date of last participant enrolment
Anticipated
Actual
18/08/2016
Date of last data collection
Anticipated
30/06/2017
Actual
31/03/2017
Sample size
Target
460
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2026 0
Port Kembla Hospital - Warrawong
Recruitment hospital [2] 6850 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 7729 0
2502 - Warrawong
Recruitment postcode(s) [2] 14515 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 288638 0
Charities/Societies/Foundations
Name [1] 288638 0
Illawarra Cancer Carers
Country [1] 288638 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 287350 0
Hospital
Name [1] 287350 0
Port Kembla Hospital Palliative Care Services
Address [1] 287350 0
PO Box 21
Warrawong NSW 2502
Country [1] 287350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290492 0
Joint UOW & ISLHD Health and Medical Human Research Ethics Committee
Ethics committee address [1] 290492 0
Ethics committee country [1] 290492 0
Australia
Date submitted for ethics approval [1] 290492 0
Approval date [1] 290492 0
18/12/2013
Ethics approval number [1] 290492 0
HE13/464

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45902 0
Prof Frank Deane
Address 45902 0
Illawarra Institute for Mental Health (B22)
University of Wollongong
Northfields Avenue
Keiraville NSW 2500
Country 45902 0
Australia
Phone 45902 0
+612 4221 4523
Fax 45902 0
Email 45902 0
fdeane@uow.edu.au
Contact person for public queries
Name 45903 0
Esther Davis
Address 45903 0
Illawarra Institute for Mental Health (B22)
University of Wollongong
Northfields Avenue
Keiraville NSW 2500
Country 45903 0
Australia
Phone 45903 0
+612 4221 5624
Fax 45903 0
Email 45903 0
eld458@uowmail.edu.au
Contact person for scientific queries
Name 45904 0
Esther Davis
Address 45904 0
Illawarra Institute for Mental Health (B22)
University of Wollongong
Northfields Avenue
Keiraville NSW 2500
Country 45904 0
Australia
Phone 45904 0
+612 4221 5624
Fax 45904 0
Email 45904 0
eld458@uowmail.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn acceptance and commitment therapy self-help intervention for carers of patients in palliative care: Protocol of a feasibility randomised controlled trial.2019https://dx.doi.org/10.1177/1359105316679724
N.B. These documents automatically identified may not have been verified by the study sponsor.