Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001315808
Ethics application status
Approved
Date submitted
11/05/2021
Date registered
27/09/2021
Date last updated
15/04/2024
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
iACT: Information and acceptance and commitment therapy (ACT) based self-help intervention for carers of people with advanced cancer.
Scientific title
iACT: Feasibility trial of an information and acceptance and commitment therapy (ACT) based self-help intervention for carers of people with advanced cancer.
Secondary ID [1] 303818 0
None
Universal Trial Number (UTN)
Trial acronym
iACT
Linked study record
ACTRN12614000150640

The 'Being There' manual and associated support calls used in the study linked above are being used in the current study. A number of changes have been made to the previous study design and will be tested for feasibility e.g. online recruitment expanded to carers of patients with advanced cancer (as opposed to within a palliative care unit), increased support calls and the addition of a facebook support group.

Health condition
Health condition(s) or problem(s) studied:
advanced cancer 321896 0
psychological well-being 321897 0
Condition category
Condition code
Mental Health 319625 319625 0 0
Studies of normal psychology, cognitive function and behaviour
Cancer 320761 320761 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited via online/social media advertising and within physical sites in Australia.
Participants will be provided access to an information hub, an acceptance and commitment therapy (ACT) manual and an online support group for participants facilitated by the study psychologist.
The information hub will be embedded within the study web page and will contain links to legitimate sources of written and video information that includes topics such as physical, psychological, spiritual and cultural, caring tips and information, patient and carer perspectives. The information hub will include video that outlines the resource links provided and also explains why some questions are difficult to answer and recommends carers seek support to manage distress that arises when dealing with the unknown. Participants will not be advised to spend any certain amount of time browsing these links; this will be determined by a participant's informational needs and their own preferences.

Based on ACT, the self-help manual created by Davis et al (2020) is designed to help carers cope better with their situation through psychoeducation and experiential exercises. The manual has 66 pages including 9 modules and 14 exercises (including 4 accompanying audio recordings). It will be available to participants in hard copy and as an electronic version on the study website.
A health professional (psychologist with at least introductory training in ACT) will contact participants within one week of recruitment/baseline assessment and offer up to four support check-ins (approximately 15 minutes in length via phone, video call, text or an email – depending on participant preference). The health professional and participant will establish a flexible schedule for these check-ins (over the course of one month). The purpose of the support check ins is to review participant progress and answer any questions about the information or exercises provided. The psychologist will respond with positive and encouraging feedback and offer advice and instruction.

The intervention manual is designed to be taken at the participant's own pace. Instructions provided within state "Some people may prefer to review the whole booklet in one or two sittings. If so, we strongly recommend that you return to it and review the content and exercises again at a later date. This allows you to integrate the skills over a longer period
of time. Others may choose to complete the booklet more slowly. The intervention period is considered to be 1 month (post baseline); support check-ins will be conducted within this timeframe and participants will be encouraged to complete the manual within this time frame.

Participants will be offered the opportunity to join the study’s Facebook support group page. The group will be the ‘secret’ group setting from Facebook; a secret group that involves only those an administrator allows to participate. Participants are not required to post to the Facebook group page. Upon enrollment we will advise participants that if we become concerned about any one individual's need for additional counselling we will refer him or her to appropriate services.

Approximately bi-weekly (depending on participant recruitment rate), material from the iACT manual and other relevant psychological support material (based on the observations of the discussions and clinical reasoning by the psychologist) will be posted on the group Facebook page, followed by a discussion question from the psychologist. The psychologist will review postings daily and respond when appropriate (clarifying, answering questions, offering encouragement, or asking additional facilitating questions).

As part of the feasibility data to inform a future effectiveness trial, participants will be offered the option to engage in study components via internet, phone and traditional hard copy/mail out methods. The participant follow-up survey includes questions as to which components of the intervention the participant engaged in.

Qualitative Interviews
Following completion of the intervention and follow-up survey, participants who consent to be contacted will be contacted with an invitation to participate in a qualitative interview. Individual qualitative interviews will be conducted until informational redundancy is reached. The interviews will be guided by a semi-structured interview guide and be approximately 30 minutes in length. Participants will have the option of completing the interviews via telephone or video call– depending on their preference. Interviews will be audio recorded and transcribed.
Intervention code [1] 320539 0
Lifestyle
Intervention code [2] 320540 0
Behaviour
Intervention code [3] 320541 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327484 0
Feasibility, by participant recruitment rate of participants screened as eligible (measured by study records).
Timepoint [1] 327484 0
End of 2 month recruitment period
Primary outcome [2] 327485 0
Feasibility, by retention to the study (completing the intervention phase and follow-up measurement; as measured by study records)
Timepoint [2] 327485 0
End of 3 month follow-up period (3 months post recruitment)
Primary outcome [3] 327487 0
Acceptability of the data collection procedures, by self-report purpose designed questions in 3 month follow up participant survey.
Timepoint [3] 327487 0
End of 3 month follow-up period (3 months post recruitment)
Secondary outcome [1] 395316 0
Experiential avoidance as assessed by the Experiential Avoidance in Caregiving Questionnaire (EACQ) in participant surveys
Timepoint [1] 395316 0
Baseline and 3 month follow up (3 months post recruitment)
Secondary outcome [2] 395317 0
Valued living as assessed by the Values Questionnaire (Smout 2014) in participant surveys
Timepoint [2] 395317 0
Baseline and 3 month follow up (3 months post recruitment)
Secondary outcome [3] 395319 0
Anticipatory grief as assessed by the Prolonged Grief Scale; PG-12) in participant surveys
Timepoint [3] 395319 0
Baseline and 3 month follow up (3 months post recruitment)
Secondary outcome [4] 395320 0
Psychological well-being as assessed by the Mental Health Continuum-Short Form; MHC-SF) in participant surveys
Timepoint [4] 395320 0
Baseline and 3 month follow up (3 months post recruitment)
Secondary outcome [5] 399485 0
Primary outcome: Acceptability of the intervention, by self-report purpose designed questions in 3 month follow up participant survey.
Timepoint [5] 399485 0
End of 3 month follow-up period (3 months post recruitment)
Secondary outcome [6] 399488 0
Social support as assessed by the Perceived Social Support Caregiving instrument (PSSC) in participant surveys
Timepoint [6] 399488 0
Baseline and 3 month follow up (3 months post recruitment)

Eligibility
Key inclusion criteria
Self-identify as an informal carer of a person diagnosed with advanced cancer (defined as a diagnosis that has been described to the person as stage 4/advanced/metastatic, and is incurable or terminal); be residing in Australia; have sufficient comprehension of English to be able to give informed consent, understand and complete the study documents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self-identify as an informal carer of a person who has not been diagnosed with advanced cancer (defined as a diagnosis that has been described to the person as stage 4/advanced/metastatic, and is incurable or terminal); people who do not have access to phone or email for the purpose of participating in support contacts.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary objective of this project is to determine the feasibility and acceptability of the proposed intervention. Formal power calculations are not typically undertaken in feasibility trials. Based on the recruitment timeline and recommendations for feasibility studies we intend to recruit 30 carers. To account for caregiver drop out of 30% as seen in similar studies, we inflate this to 50.

Descriptive statistics on the number of eligible participants, recruitment and retention rate, reasons for dropout, protocol completion, number of support check-ins and acceptability items will be provided. Descriptive analysis of baseline demographics and clinical characteristics will be presented. Paired t-tests will compare scores from baseline to 3 months for the following outcomes
• Experiential avoidance
• Anticipatory grief
• Valued-living
• Psychological well-being
• Social support

Qualitative Interviews
Interviews will continue until informational redundancy is reached (hypothesised to be approximately 10 participants) to further explore the feasibility and acceptability of the self-help intervention, and the potential barriers for carers.
Qualitative interview data will be analysed using a thematic analysis approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2022
Actual
28/08/2022
Date of last participant enrolment
Anticipated
30/12/2022
Actual
11/07/2023
Date of last data collection
Anticipated
31/03/2023
Actual
11/10/2023
Sample size
Target
50
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 19430 0
Muswellbrook Hospital - Muswellbrook
Recruitment postcode(s) [1] 34011 0
2333 - Muswellbrook

Funding & Sponsors
Funding source category [1] 308216 0
Other Collaborative groups
Name [1] 308216 0
Hunter Cancer Research Alliance
Country [1] 308216 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309438 0
None
Name [1] 309438 0
Address [1] 309438 0
Country [1] 309438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308197 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 308197 0
Ethics committee country [1] 308197 0
Australia
Date submitted for ethics approval [1] 308197 0
29/04/2021
Approval date [1] 308197 0
12/08/2021
Ethics approval number [1] 308197 0
2020/ETH02920

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

Contacts
Principal investigator
Name 109894 0
Dr Kristen McCarter
Address 109894 0
University of Newcastle
PO Box 833
Newcastle, NSW
2300
Country 109894 0
Australia
Phone 109894 0
+61405697756
Fax 109894 0
Email 109894 0
[email protected]
Contact person for public queries
Name 109895 0
Kristen McCarter
Address 109895 0
University of Newcastle
PO Box 833
Newcastle, NSW
2300
Country 109895 0
Australia
Phone 109895 0
+61405697756
Fax 109895 0
Email 109895 0
[email protected]
Contact person for scientific queries
Name 109896 0
Kristen McCarter
Address 109896 0
University of Newcastle
PO Box 833
Newcastle, NSW
2300
Country 109896 0
Australia
Phone 109896 0
+61405697756
Fax 109896 0
Email 109896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.