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Evaluation of a stepped-care approach (Fear-Less) to treat fear of cancer recurrence in cancer survivors

Feasibility and acceptability of a stepped-care approach (Fear-Less) to treat fear of cancer recurrence in cancer survivors with early stage disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000818730
Acronym
Fear-Less
Enrollment
53
Registered
2022-06-10
Start date
2021-11-24
Completion date
2022-07-04
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Fear of cancer recurrence (FCR) is the fear, worry or concern cancer will come back or progress. It is a significant unmet need for cancer survivors and has been consistently linked with psychological distress and lower quality of life. Over the past decade, a number of psychological treatments have been developed to better address FCR in cancer survivors, however, there are barriers to the uptake of these treatments, such as a lack of routine screening and limited availability of therapists. A stepped-care treatment model for FCR may help overcome these barriers, and involves offering treatments of differing intensity tailored to survivors' level of symptoms as identified through routine screening. The aim of this study is to assess the feasibility, acceptability, and efficacy of this approach in cancer survivors with early stage disease. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are a breast, head and neck, or gynaecology cancer survivor with early stage disease who has completed initial curative treatment. Study details Survivors who have completed FCR screening will be invited to take part in the stepped-care program and to complete a survey about the screening. Those with low FCR will receive treatment as usual, which will involve attending their usual appointments with medical/nursing teams, where they may be provided with details about how to access psychological services should they be required. Those with moderate FCR will be offered an educational self-management booklet designed specifically for this study. These participants will be posted the booklet and provided education on the booklet by phone by a clinical psychologist. These participants will also receive a phone call from the clinical psychologist at 3 weeks and 5 weeks after receipt of the resource to discuss their treatment needs and any follow-up support required. Participants with high levels of FCR will be offered ConquerFear therapy, which consists of five individual 60-minute sessions delivered by a clinical psychologist every 1-2 weeks over a period of 10 weeks. These sessions will focus on strategies for managing worry, changing unhelpful beliefs, education on follow-up care, and goal-setting. Participants will also be instructed to complete home-based practice of skills learned during the sessions and home reading to consolidate skill acquisition. For participants who receive the self-management booklet or undertake the ConquerFear therapy, follow-up assessments will occur via telephone to determine their level of FCR and any further supports needed. They will be asked to fill in a survey about the intervention they received. It is hoped that this study may show that a stepped-care approach is feasible, acceptable, and effective for managing FCR in cancer survivors, which may help to shape the care of other cancer survivors in future.

Interventions

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 experie

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.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

• Cancer survivors diagnosed with metastatic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026