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Trial registered on ANZCTR


Registration number
ACTRN12618000406202
Ethics application status
Approved
Date submitted
18/02/2018
Date registered
21/03/2018
Date last updated
2/07/2021
Date data sharing statement initially provided
17/06/2019
Date results provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing a psychological intervention for cancer-related anxiety
Scientific title
Pilot testing a novel, theoretically derived psychological intervention for cancer-related anxiety
Secondary ID [1] 294081 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Nil known
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Cancer 306646 0
Anxiety 306770 0
Condition category
Condition code
Cancer 305746 305746 0 0
Any cancer
Mental Health 305864 305864 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is 9 sessions of manualised psychological therapy which will be provided weekly for 60-90 minutes. The content of sessions is derived from previously validated therapies, such as Cognitive Behaviour Therapy, Metacognitive Therapy and Acceptance and Commitment Therapy. In particular, the session content will be as follows:
Session 1. Psychological assessment and development of a formulation to identify targets for intervention and to provide psycho-education about anxiety in general and in this context in particular
Session 2. Discuss the problem of uncontrollability in the cancer context, helpful vs unhelpful control attempts and provide a framework for helpful coping. (cf. Morling & Evered, 2006) and expand on helpful coping repertoire.
Session 3. Begin to learn techniques for responding to difficult thoughts and emotions
(i) Provide psycho-education about the nature of intrusions
(ii) Discuss the utility of emotions and increasing awareness of one’s current experience (Barlow, 2011)
(iii) Introduce a framework to aid decision making about when to process or disengage from unhelpful thoughts and emotions - the ReFleCT flowchart.
(iv) Introduce Detached Mindfulness (Wells, 2005) as an alternative to rumination
(v) Values clarification and goal setting
Session 4. Introduce the cognitive model (Beck, 1995) and Attention Training (Wells, 2005)
Session 5. Introduce cognitive reframing skills and practice an example in the session
Session 6. Belief modification including providing psycho-education about underlying beliefs and practice modifying a belief identified in the individual’s formulation as contributing to their cancer-related anxiety using relevant cognitive and behavioural techniques.
Session 7. Ongoing belief modification with a belief identified in the formulation. Introduce mindfulness and practice a short exercise in the session (Kabat-Zinn ,1990, Harris, 2009; Roemer & Orsillo, 2011).
Session 8. Address any remaining avoidance or over-monitoring by identifying any remaining maladaptive coping behaviours and associated beliefs and distinguishing between over-monitoring / excessive health behaviours and reasonable surveillance /health behaviours. review mindfulness skills and practice a brief mindfulness exercise.
Session 9. Review the program and introduce strategies to prevent relapse prevention by identifying potential future triggers and developing new plans for dealing with uncertainty and worry
The intervention will be conducted individually in face to face consultations by a Clinical Psychologist who has a minimum of 5 years experience delivering psychological interventions to cancer patients.
Adherence to the intervention will be monitored by 1) the therapist will complete a checklist at the end of each session to indicate if the components of the session plan where completed and 2) therapy sessions will be voice recorded and a proportion of sessions (11% or 15 therapy sessions) will be randomly audited by the Principal Investigator to ensure that the sessions adhere to the therapy manual.
.
Intervention code [1] 300353 0
Behaviour
Intervention code [2] 300433 0
Treatment: Other
Comparator / control treatment
This is a Phase I pilot trial. There is no comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304821 0
Anxiety: Hospital and Anxiety Scales - Anxiety subscale (Zigmond & Snaith, 1983) – 7 items assess symptoms of anxiety.
Timepoint [1] 304821 0
Baseline (T1), at the completion of each therapy session (T 2-10), and two months post-intervention (T11).
Primary outcome [2] 304822 0
Cancer-specific distress:Impact of Events Scale - Revised (Weiss & Marmar, 1997) – 22 items assess symptoms of post traumatic stress that characterize cancer-related distress
Timepoint [2] 304822 0
Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11).
Primary outcome [3] 304823 0
Cancer-related anxiety: Fear of progression Questionnaire short-form (Mehnert, Herschbach, Berg, Henrich, & Koch, 2006) – 12 items assess fears about cancer recurrence or progression
Timepoint [3] 304823 0
Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11).
Secondary outcome [1] 343300 0
Death Anxiety Questionnaire (Conte, Weiner, & Plutchik, 1982) - 15 items assess worries about death and dying
Timepoint [1] 343300 0
Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11).
Secondary outcome [2] 343301 0
Center for Epidemiologic Studies Depression Scale – short form (Andresen, Malmgren, Carter, & Patrick, 1994) - 10 items assess symptoms of depression
Timepoint [2] 343301 0
Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11).
Secondary outcome [3] 343302 0
McGill Quality of Life questionnaire – Revised (Cohen et al., 2017) – 14 items assess Quality of Life
Timepoint [3] 343302 0
Baseline (T1), at the completion of the 9 week intervention (T10) and two months post-intervention (T11).
Secondary outcome [4] 343589 0
Face validity and acceptability of the intervention will be assessed with a measure developed for a previous pilot study with cancer patients (Smith et al, 2015) that asked participants to rate how effective and essential each session was on a 10 point scale.
Timepoint [4] 343589 0
After each therapy session (T2-10)
Secondary outcome [5] 343594 0
Feasibility and retention will be assessed by calculating 1) the proportion of contacted patients who are eligible to participate and are recruited into the pilot 2) the proportion of participants who complete the study 3) the proportion of participants who provide follow-up data.
Timepoint [5] 343594 0
At completion of the study

Eligibility
Key inclusion criteria
• Patients with a diagnosis of metastatic cancer or patients who have experienced a recurrence or progression of their cancer or a second cancer diagnosis
• Aged 18 or over
• Fluent in English
• Clinically significant anxiety as measured by a score of 8 or more on the Hospital Anxiety and Depression Scale– Anxiety subscale (HADS-A, Zigmond & Snaith, 1983) OR a score of 19 or more on the Impact of Events Scale - Revised (Weiss & Marmar, 1997) OR a score of 34 or more on the Fear of Progression questionnaire, Short version (Mehnert, Herschbach, Berg, Henrich, & Koch, 2006).
• Willingness to give written informed consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Mental health condition predating cancer diagnosis requiring ongoing treatment, such as major depression, bipolar, psychosis, borderline personality disorder or substance dependence
• Current suicidal risk.
• Receiving concurrent psychological treatment
• Taking psychotropic medication unless
1) the dose has been stable for at least 8 weeks
2) the medication was prescribed as a pre-medication before chemotherapy treatment or a medical procedure or
3) the medication was prescribed specifically to treat nausea.
• Cognitive impairment as measured by a score of <27 on the Telephone Interview for Cognitive Status - modified (Brandt, Spencer, & Folstein, 1988; Welsh, Breitner, & Magruder-Habib, 1993)

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
Designed as a feasibility, pilot trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Whitehead et al (2016) suggest that the size of pilot study should be related to the size of the definitive RCT (the CONSORT Guidelines for randomised pilot and feasibility studies, Eldridge et al, 2016). For a RCT designed with 90% power and two sided 5% significance, the recommended pilot trial sample size for each treatment arm is 25; 15 and 10 for standardized effects sizes that are small (0.2), medium (0.5) or large (0.8) respectively. A previous intervention study with cancer patients with fear of cancer recurrence (Smith et al, 2015), on which this intervention is based, suggests that a medium effect size is expected, and so we have chosen a sample size of 15.

Feasibility and acceptability data will be reported using descriptive statistics. Psychological outcome data will be analysed using a linear mixed model with a random subject effect to account for longitudinal data and time modelled continuously. Post-treatment and 2-month follow-up changes from baseline will be calculated from this model. Mixed models yield reasonable estimation with small samples (Kenward & Roger, 1997). A reliable change index (RCI) will be calculated for the anxiety score for each participant at both follow-up time points. Participants will be deemed to have experienced clinically significant improvements if RCI>1.96 (Jacobson & Traux, 1991).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/03/2018
Actual
20/04/2018
Date of last participant enrolment
Anticipated
21/12/2018
Actual
27/05/2019
Date of last data collection
Anticipated
11/10/2019
Actual
10/11/2019
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10050 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 21567 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 298712 0
University
Name [1] 298712 0
The University of Sydney
Country [1] 298712 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
School of Psychology
Brennan MacCallum Building A18
Manning Rd
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 297882 0
Hospital
Name [1] 297882 0
The Kinghorn Cancer Centre, St. Vincent's Hospital
Address [1] 297882 0
370 Victoria Rd,
Darlinghurst NSW
2010
Country [1] 297882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299658 0
St Vincent's Hospital, Darlinghurst
Ethics committee address [1] 299658 0
Ethics committee country [1] 299658 0
Australia
Date submitted for ethics approval [1] 299658 0
09/11/2017
Approval date [1] 299658 0
05/12/2017
Ethics approval number [1] 299658 0
HREC/17/SVH/343

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

Contacts
Principal investigator
Name 81202 0
Prof Louise Sharpe
Address 81202 0
School of Psychology, Faculty of Science
Room 450, Brennan MacCallum (A18)
Manning Road
The University of Sydney,
Camperdown, NSW, 2006
Country 81202 0
Australia
Phone 81202 0
+61 2 9351 4558
Fax 81202 0
Email 81202 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 81203 0
Leah Curran
Address 81203 0
c/o The Kinghorn Cancer Centre, St Vincent’s Healthcare Network,
370 Victoria Rd,
Darlinghurst,
NSW 2010
Country 81203 0
Australia
Phone 81203 0
+61 2 93555643
Fax 81203 0
Email 81203 0
lcur6474@uni.sydney.edu.au
Contact person for scientific queries
Name 81204 0
Louise Sharpe
Address 81204 0
School of Psychology, Faculty of Science
Room 450, Brennan MacCallum (A18)
Manning Road
The University of Sydney,
Camperdown, NSW, 2006
Country 81204 0
Australia
Phone 81204 0
+61 2 9351 4558
Fax 81204 0
Email 81204 0
louise.sharpe@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
From completion of data write-up (approx Dec 2019) for 20 years (approx Dec 2039).
Available to whom?
Researchers who provide a sound methodological argument to view the data and at the discretion of the primary sponsor
Available for what types of analyses?
for meta-analyses
How or where can data be obtained?
Access subject to approval by the Prinicpal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12390Study protocol  louise.sharpe@sydney.edu.au
12391Informed consent form  louise.sharpe@sydney.edu.au
12392Analytic code  louise.sharpe@sydney.edu.au
12393Ethical approval  louise.sharpe@sydney.edu.au



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.