Short summary

Enhanced focus of early detection and improved treatment of cancer have led to an increased number of cancer survivors. Not all patients find it easy to survive cancer, and the life changing event might make it difficult to navigate in everyday life. 

This study aims at reducing fear of cancer recurrence in colorectal cancer survivors by testing a web-based intervention in a randomised controlled trial. 

Rationale

Background

Colorectal cancer screening, early detection and improved cancer treatment have increased survival rates of colorectal cancer (CRC) patients over the past decade and survival rates are still rising. This improvement results in an increasing number of long-term CRC survivors with no residual disease. The survivors intend to return to jobs and normal life circumstances, but some survivors experience difficulties in normal functioning and a decreased quality of life due to substantial psychological strain. Most cancer survivors experience fear of cancer recurrence (1). The severity of self-reported FCR does not seem to differentiate much between different cancer types(2) and FCR tends to persist also among very long term survivors(3). 

FCR is a prevalent, disabling and long-lasting late adverse effect defined as "Fear, worry or concern relating to the possibility that cancer will come back or progress(4)" and is characterized by "A preoccupation with the cancer returning or progressing, unhelpful coping behaviors, impairment to daily function, clinically significant distress and limited capacity for making future plans(4)". 

FCR is associated with several psychological factors like anxiety including health anxiety (Ref), depression (Ref), perceived uncertainty in illness, perceived risk of recurrence and negative beliefs about worry (5, 6). 

The prevalence of FCR in CRC survivors has been estimated based on studies with limited number of participants(7, 8), or studies with very simple(9, 10) or non-validated(8) FCR measurements. None seems to control for functional disorders. Some/moderate FCR is reported by the majority of CRC survivors(7-10). Recent minor studies using a validated measurement method (Fear of Cancer Recurrence Inventory, FCRI) report high/pathological FCR among 13,7 % (11) and 10,1 %(12) (Unpublished data, personal communication).

Great cohort studies exists, but FCR may not be the primary outcome (10, 13), or no cut-off score exist for assessment of severity of FCR(2), or the cohort includes people "living with and beyond cancer" and does not distinguish between survivors with no residual disease, with cancer still present or with a history of recurrence (13-15). 26,5 % of CRC survivors(15) and 20-56 % of people living with and beyond CRC cancer(16) reports psychosocial assistance in coping with FCR to be an important unmet need. CRC survivors identified through the colorectal cancer screening program, as opposite to survivors initially diagnosed as a result of symptoms might have other issues in coping with the cancer diagnose, but this research field seems to be untouched. 

Randomized clinical trials testing interventions for reducing FCR is primarily conducted in breast cancer survivors and mixed cancer populations. Most interventions are based on variations of cognitive-behavioral therapy (CBT). The delivery format has been (or are launched) in groups(17-19), face-to-face(20-22), blended(23), by telephone(24, 25) or by web-based platforms(26-29). 

"ConquerFear" (20) is an RCT-tested intervention efficient in reducing FCR in a mixed cancer group delivered individually face-to-face. As this is a resource- and time consuming, logistic challenging and demanding approach, ConquerFear is now transformed into a solely self-managed web-based version (iConquerFear), similar in curriculum content, but different in delivery.

Web-based interventions have the potential to fill an important gap in quality cancer care by augmenting limited available mental health services(30). Web-based cognitive behavioral therapy has advantages for both patients and providers and the effect seems to be comparable to traditional face-to-face therapy in treating distress in patients with cancer(31, 32). As guided interventions are significantly superior to unguided interventions (33), the primary aim of this RCT is to i) test if a therapist guided version of iConquerFear (TG-iCF) can ease FCR and improve quality of life for CRC survivors more than treatment as usual (TAU).  

Secondary objectives are to ii) outline the prevalence of FCR in a population based CRC cohort with a detailed and validated measure of FCR with a clinical cut-off in up till 5 years after diagnose. This comprehensive screening will be used as recruitment for the RCT. ii) Investigate whether being diagnosed as a consequence of the implementation of the colorectal cancer screening program increases FCR and iii) investigate whether FCR is associated with anxiety, depression, bodily distress syndrome and health anxiety in CRC survivors. 

Description of the cohort

All Danish colorectal cancer survivors above 18 (estimated 17.000) diagnosed after implementation of the colorectal cancer screening programme in March 2014 who have undergone treatment with surgery +/- radiation and +/- adjuvant chemotherapy will be invited to participate.  

Exclusion criteria are severe psychiatric disorder, cancer recurrence at any follow-up and substance abuse. 

Data and biological material

Questionnaires and register data.

The Fear of Cancer Recurrence Inventory

Visual analog scale for general health conditions and quality of life

The SCL checklist for anxiety, depression and bodily distress syndrome 

The Whiteley-8 on health anxiety

The MCQ on negative belief about worry 

The MUIS on uncertainty in illness

The percieved risk of recurrence 

Collaborating researchers and departments

Department for Oncology, Sygehus Lillebælt, Vejle

• Consultant, main supervisor Lars Henrik Jensen

Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital

• Professor Per Fink, PhD
• Psychologist Lisbeth Frostholm, PhD

Centre for Oncology Education and Research Translation (CONCERT), Sydney, Australia

• Translational Research Fellow Allan 'Ben' Smith