Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000818730
Ethics application status
Approved
Date submitted
23/05/2022
Date registered
10/06/2022
Date last updated
30/09/2022
Date data sharing statement initially provided
10/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a stepped-care approach (Fear-Less) to treat fear of cancer recurrence in cancer survivors
Scientific title
Feasibility and acceptability of a stepped-care approach (Fear-Less) to treat fear of cancer recurrence in cancer survivors with early stage disease
Secondary ID [1] 307080 0
None
Universal Trial Number (UTN)
Trial acronym
Fear-Less
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326242 0
Fear of cancer recurrence 326243 0
Condition category
Condition code
Cancer 323541 323541 0 0
Breast
Cancer 323542 323542 0 0
Head and neck
Cancer 323543 323543 0 0
Ovarian and primary peritoneal
Cancer 323544 323544 0 0
Womb (Uterine or endometrial cancer)
Mental Health 323545 323545 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates the feasibility and acceptability of a stepped-care model to identify and treat fear of cancer recurrence (FCR) in cancer survivors. This includes evaluating screening processes as well as the interventions offered.

The stepped-care model involves stratified care, in which participants will be stratified to the steps below based on their scores on the Fear of Cancer Recurrence Inventory – Short Form (FCRI-SF).

Step 1: Treatment as usual
Participants identified as experiencing low FCR (score of <13 on the FCRI-SF) will continue with their usual care with their medical and nursing teams, and will be provided details about how to access psychological intervention should they need services. No further follow-up or additional screening will be undertaken for these participants. These participants will be asked to complete an evaluation survey about their screening experiences.

Step 2: Guided self-management intervention (duration = 5 weeks)
Participants identified as experiencing moderate/subthreshold levels of FCR (score of 13-21 on FCRI-SF) will have a brief discussion with a clinical psychologist on the research team to confirm they are concerned about their level of FCR and would like support for it. Participants who agree to proceed will be offered the clinician-guided self-management intervention. The self-management resource is a colour printed booklet consisting of psychoeducation regarding FCR and strategies to manage FCR. The booklet was purposely designed for this study, based on an existing booklet developed by our team at Peter Mac for Stage 4 melanoma survivors experiencing FCR.

A clinical psychologist will introduce and provide education regarding the resource at point of referral acceptance by the participant. This will occur by phone. The clinical psychologist will then provide the resource as a digital copy via email or hard copy by post (depending on participant preference). Participants will be contacted over the phone after approximately three weeks of receipt of the resource to provide phone support and further education as needed. Participants will also be contacted via phone five weeks after receipt of the self-management resource. During this call, final education and phone support will be offered. The participant may also re-complete the FCR screening measures over the phone, after which their current treatment needs and options for follow-up clinical support will be discussed. This may include no further treatment, or referrals to services such as a psychiatrist, individual therapy, peer supports or community services GP. Each phone call is expected to take 20 minutes.

Participants will also be asked to complete an evaluation survey following the 5 week intervention to provide feedback and self-report their adherence to reading the resource and practising the strategies suggested.

Step 3: Individual intervention (duration = 5 sessions)
Participants identified as experiencing high/clinical levels of FCR (score of =>22 on the FCRI-SF) will have a brief discussion with a clinical psychologist on the research team member to confirm the severity of FCR and whether they would like support for it. Factors that will be assessed during this discussion will include the frequency, emotional impact, functional impact, and avoidance of FCR. Participants whose assessment indicates clinical levels of FCR will be offered ConquerFear. Participants who are considered to have sub-threshold FCR, or who do not wish to take part in the ConquerFear therapy, will be offered the self-management intervention.

ConquerFear is an established treatment protocol for FCR, which consists of five individual sessions teaching survivors strategies to manage worry and excessive FCR, and promote value-based goal setting. Each session will be approximately 60 minutes every 1-2 weeks and will be facilitated by a clinical psychologist face-to-face or via telehealth as needed (e.g., general health recommendations during the pandemic). Face-to-face sessions will be held at Peter MacCallum Cancer Centre. Telehealth will be offered via online video sessions. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. For example, participants are asked to practice the Attention Training Technique (15min) daily, or provided written material to consolidate what has been discussed during the session. It is expected this practice and reading will take 1-2 hours total between sessions.

The key goals of the Conquer Fear therapy are to:
a) Teach strategies for managing worry and excessive threat monitoring
b) Modify underlying unhelpful beliefs about worry
c) Develop appropriate monitoring and screening behaviours
d) Educate about follow-up care and empirically-supported behavioural change (e.g., weight loss, exercise etc.) to reduce the risk of cancer recurrence
e) Address existential changes brought about by a cancer diagnosis
f) Promote goal-setting

The fidelity of the ConquerFear treatment protocol will be assessed through a review of each session by the psychologists administering the treatment. This will be completed using session checklists usually included in the ConquerFear protocol. The checklist will be completed at the end of each session.

At the final session, participants will be asked to re-complete FCR screening measures and their current treatment needs and options for follow-up clinical support will be discussed. This may include no further treatment, or referrals to services such as a psychiatrist, individual therapy, peer supports or community services GP. Participants will also be asked to complete an evaluation survey to provide feedback on the intervention.
Intervention code [1] 323534 0
Treatment: Other
Intervention code [2] 323535 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331296 0
Acceptability of the Fear-Less stepped care program via purpose developed surveys evaluating survivors' experiences of the screening procedures and the intervention received
Timepoint [1] 331296 0
Post-FCR screening/pre-intervention
Immediately post-intervention completion
Primary outcome [2] 331297 0
Acceptability of the Fear-Less stepped care program via purpose developed survey evaluating clinicians' experiences of the screening procedures and intervention delivery
Timepoint [2] 331297 0
At the completion of recruitment of survivors into the stepped-care program
Primary outcome [3] 331567 0
Feasibility of the Fear-Less stepped care program via collection of data on clinician time taken to administer screening and deliver interventions. This information will be entered in a case report form for each participant
Timepoint [3] 331567 0
Across the span of the study
Secondary outcome [1] 409461 0
Primary outcomes continued

Feasibility of the Fear-Less stepped care program via collection of data on screening rates. This will be assessed by calculating the proportion of survivors who accept/decline screening
Timepoint [1] 409461 0
At the tie participants are approached to complete screening
Secondary outcome [2] 410315 0
Primary outcomes continued

Feasibility of the Fear-Less stepped care program via collection of data on referral uptake. This will be assessed by calculating the proportion of survivors who accept/decline intervention if offered
Timepoint [2] 410315 0
Post-FCR screening/pre-intervention
Secondary outcome [3] 410316 0
Primary outcomes continued

Feasibility of the Fear-Less stepped care program via collection of data on adherence to the self-management intervention. This will be assessed by a self-report of % of self-management resource completed by the participant (>75%)
Timepoint [3] 410316 0
At completion of intervention (5 weeks after receipt of self-management resource)
Secondary outcome [4] 410317 0
Primary outcomes continued

Feasibility of the Fear-Less stepped care program via collection of data on number of Conquer Fear sessions attended. This will be assessed by calculating the number of sessions attended by each participant receiving Conquer Fear
Timepoint [4] 410317 0
At completion of the 5 sessions of Conquer Fear by reviewing the case report form for each participant undergoing the intervention
Secondary outcome [5] 410318 0
Impact of the intervention (either self-management or Conquer Fear) via the Fear of Cancer Recurrence Inventory - Short Form
Timepoint [5] 410318 0
Post-intervention, either after 5 weeks with the self-management resource or after 5 Conquer Fear sessions
Secondary outcome [6] 410319 0
Impact of the intervention (either self-management or Conquer Fear) via the Fear of Cancer Recurrence - 1 Item Measure
Timepoint [6] 410319 0
Post-intervention, either after 5 weeks with the self-management resource or after 5 Conquer Fear sessions

Eligibility
Key inclusion criteria
For survivors who are participants:
• Aged 18 years and over
• Breast, head and neck, gynaecological cancer survivors with early stage disease who have completed initial curative treatment
• Cancer survivors able to read and write English
• Cancer survivors able to give informed consent

For clinicians who are participants:
• All clinicians involved in the study will be invited
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cancer survivors diagnosed with metastatic disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Target sample size is 60 cancer survivors. As there is currently no clear consensus regarding appropriate sample size for feasibility studies (Lewis et al., 2021), this target sample size is based on available funding, resources (e.g., clinician time to deliver the stepped-care interventions) and study duration of 18 months. This sample size is also in line with previous pilot and feasibility trials (Billingham et al., 2018), including our previous feasibility study for Fear-Less amongst survivors with stage IV melanoma (Lynch et al., 2020).

All clinicians involved in the study will be invited to participate. The anticipated number of clinicians who will complete the clinician survey is 10.

Descriptive statistics will be used to summarise demographic, clinical and operational data, initial responses to the FCRI-SF and FCR-1, and responses to relevant questions from the evaluation surveys. Initial responses to the FCRI-SF will also be recoded to discrete variables comprising three ordered categories (low, moderate, high); then relative frequencies will be computed for each variable.

Quantitative data
Change scores will be calculated for all participants who accept the self-management resource and all participants who agree to participate in the ConquerFear intervention. For each group, participants who report a reduction of 10% or more on the FCRI-SF and FCR-1 will be summarised with a proportion and 95% confidence interval; the latter will be estimated using the Wilson method. As appropriate, paired samples t-tests will be used to compare FCRI-SF and FCR-1 before and after intervention. Tests will be performed separately for participants who accepted the self-management resource and those that agree to participate in the ConquerFear intervention. Tests will be performed for both the full sample for each intervention, and separately for those who completed an acceptable level of the intervention; defined as reading 75% or more of the self-management booklet according to self-report (Q4 added to Patient Experiences Survey), or completing four or more sessions of the Conquer Fear intervention. These analyses are contingent on the project obtaining an appropriate sample size that may not be reached.

Qualitative data
Free text items from the patient and clinician surveys will be analysed using summarising content analysis. A deductive approach will be used for coding data. Pre-defined categories will be formulated based on the research questions informing the study. Additional inductive codes will be identified from the survey responses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/11/2021
Date of last participant enrolment
Anticipated
9/06/2022
Actual
4/07/2022
Date of last data collection
Anticipated
29/07/2022
Actual
16/09/2022
Sample size
Target
70
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22330 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 22331 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 22332 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 37491 0
3000 - Melbourne
Recruitment postcode(s) [2] 37492 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 311390 0
Government body
Name [1] 311390 0
Victorian Government Department of Health
Country [1] 311390 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Parkville VIC 3000
Country
Australia
Secondary sponsor category [1] 312780 0
None
Name [1] 312780 0
N/A
Address [1] 312780 0
N/A
Country [1] 312780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310873 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 310873 0
Ethics committee country [1] 310873 0
Australia
Date submitted for ethics approval [1] 310873 0
12/04/2021
Approval date [1] 310873 0
14/05/2021
Ethics approval number [1] 310873 0
21/69L

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

Contacts
Principal investigator
Name 119178 0
Dr Maria Ftanou
Address 119178 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street, Parkville VIC 3000
Country 119178 0
Australia
Phone 119178 0
+61 03 8559 7174
Fax 119178 0
Email 119178 0
[email protected]
Contact person for public queries
Name 119179 0
Maria Ftanou
Address 119179 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street, Parkville VIC 3000
Country 119179 0
Australia
Phone 119179 0
+61 03 8559 7174
Fax 119179 0
Email 119179 0
[email protected]
Contact person for scientific queries
Name 119180 0
Mei Tran
Address 119180 0
Psychosocial Oncology Program
Peter MacCallum Cancer Centre
305 Grattan Street, Parkville VIC 3000
Country 119180 0
Australia
Phone 119180 0
+61 03 8559 5265
Fax 119180 0
Email 119180 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
Ethical approval for data sharing was not sought


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16011Study protocol  [email protected] 384030-(Uploaded-23-05-2022-14-24-33)-Study-related document.pdf
16174Ethical approval    384030-(Uploaded-23-05-2022-14-24-54)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for the evaluation of Fear-Less: a stepped-care program for fear of cancer recurrence in survivors with early-stage disease.2022https://dx.doi.org/10.1186/s40814-022-01123-y
N.B. These documents automatically identified may not have been verified by the study sponsor.