Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors. FCR describes the fear, worry, or concern relating to the possibility that cancer will come back or progress, and is associated with reduced quality of life as well as other psychological symptoms. Approximately 60% of cancer survivors suffer from FCR, 20% of whom suffer from severe FCR. Relatives are also burdened by FCR, which in turn negatively affects the dyadic relationship as well as the survivors' quality of life. However, to date, there is a lack of evidence-based psycho-oncological couple interventions that focus on patients'/survivors' and spouses' FCR. Meta-analyses indicate the efficacy of mindfulness- and acceptance-based approaches such as acceptance and commitment therapy (ACT) for reducing FCR. In contrast to traditional Cognitive Behavioral Therapy (CBT) approaches, which, for instance, aim to change thoughts and feelings by cognitive restructuring, ACT aims to increase psychological flexibility and promotes a more detached, acceptance-based attitude toward thoughts and feelings, as well as a value-based life orientation. However, the empirical evidence for ACT in relation to FCR still needs to be investigated more thoroughly.
This study, coping with fear of cancer recurrence (CARE-pilot), addresses these research gaps and aims to test the feasibility and preliminary efficacy of a manualized ACT couple intervention for outpatient cancer survivors (defined as cancer patients who completed primary treatment and were diagnosed \< 5 years ago) and their spouses. Sixty-four couples in which either survivor, spouse or both have elevated FCR will be randomized to either the ACT couple intervention (IG) or the traditional CBT couple intervention (active control group, CG). The IG and CG interventions consist of six psychotherapy sessions (four couple sessions and two individual sessions), the content of which is intensified in online modules between sessions (blended care). The primary endpoint of the feasibility study is the retention rate and achievement of recruitment targets. Using standardized measurements, changes in FCR, quality of life (primary endpoint of preliminary efficacy), and other psychosocial variables will be assessed at post-intervention and 3 months after the end of the intervention.
The feasibility study represents the first step in evaluating the feasibility and the practicality of the couple interventions. The CARE-Pilot study aims to evaluate the feasibility and preliminary efficacy of an ACT-based couple intervention in reducing FCR, compared to a CBT-based couple intervention, in couples navigating cancer survivorship.
cancer survivors (male/female/diverse) with any cancer entity
after completed primary treatment (not including endocrine treatment, which can be ongoing)
< five years after primary diagnosis
FCR (FoP-Q-SF total score ≥ 34) or spouses' FCR (FoP-Q-SF/P total score ≥ 34)
both patient and spouse show low FCR (FoP-Q-SF total score < 34 or FoP-Q-SF/P total score < 34)
individuals who previously (last 2 years) participated in an ACT-, CBT-, or mindfulness-based psychosocial intervention (psycho-oncological or psychotherapeutic interventions)
severe psychiatric disorders and suicidality
Parallel
ACT couple intervention
BehavioralThe ACT couples intervention comprises six sessions, consisting of four couples' sessions and two individual sessions for cancer survivors and their partners. The first and last sessions are held face-to-face and last 90 minutes. For the other sessions, couples can choose between face-to-face sessions or video-based sessions via a video conferencing tool. These sessions last 60 minutes. All ACT flexibility skills are covered. In addition, couples are given access to an online platform (CoupleACT). Through this platform, participants receive ACT-specific audio files, homework assignments and written material to help them consolidate the content covered in the sessions.
CBT couple intervention
BehavioralCBT: six sessions, comprising four couples' sessions and two individual sessions for cancer survivors and their partners. The first and last sessions are held face-to-face and last 90 minutes. For the other sessions, couples can choose between face-to-face sessions or video-based sessions via a video conferencing tool. These sessions last 60 minutes. The CBT couples intervention is based on an evaluated group therapy manual (Waadt et al., 2011). It has been adapted for the couples' context and includes, amongst other things, behavioural analysis (SORK), psychoeducation, exposure, cognitive restructuring and mindfulness training. In addition, couples are given access to an online platform (CoupleCare). Through this platform, participants receive CBT-specific audio files, homework assignments and written material to reinforce the content covered in the
Fear of Progression Questionnaire (FoP-Q-SF) and partner version (FoP-Q-SF/P)
We will assess FCR with the 12-item short form of the Fear of Progression Questionnaire (FoP-Q-SF), which is highly reliable and valid to assess FCR (68, 69). Also a validated partner version exists (FoP-Q-SF/P) which shows high reliability. (Primary outcome for preliminary efficacy). Response scale: 1-5, min. 12, max. 60. Higher scores = worse outcome (higher fear of progression); score ≥ 34 = clincial cut-off.
feasibility outcomes: retention and recruiting rate
Short-Form Health Survey (SF-12), Physical (PCS) and Mental (MCS) Component
Health-related quality of life (HRQoL), 12 items; norm-based 0-100 scoring Min. = 0, max = 100. Higher scores = better outcome (better health-related quality of life)
Personal Health Questionnaire, depression module (PHQ-9)
Assessment of depressive symptoms with 9 items, 4-point Likert scale (0-3), Min = 0; max = 27; higher scores = worse outcome (higher depression severity)
Generalized Anxiety Disorder scale (GAD-7)
Assessment of anxiety symptoms with 7 items; 4-point Likert scale (0-3). Min = 0; max = 21. Higher scores = worse outcome (higher anxiety severity)
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Assessment of distress with a single item, visual analogue scale (0-10). Min = 0; max = 10. Higher scores = worse outcome (higher distress).
Cognitive Fusion Questionnaire (CFQ)
Assessment of Cognitive fusion with 7 items, 7-point Likert scale (1-7). Min. = 7, max = 49. Higher scores = worse outcome (higher cognitive fusion)
German version of the Peace, acceptance and equanimity in cancer experience (PEACE)
Assessment of two subscales: 1. acceptance of illness with 5 items, 4-point Likert (1-4), min = 5; max = 20. Higher scores = better outcome (higher peaceful acceptance) 2. Struggle with Illness with 7 items, 4-point Likert (1-4), min = 7; max = 28. Higher scores = worse outcome (higher struggle with illness)
Valuing Questionnaire
Assessment of valued living with two subscales: 1. Values-consistent living (progress) with 5 items, 7-point Likert scale (0-6), min. = 0, max. = 30. Higher scores = better outcome (higher enactment of values) 2. Values-inconsistent living (obstruction) with 5 items, 7-point Likert scale (0-6) min.= 0, max = 30. Higher scores = worse outcome (higher interference with valued living)
Dyadic Coping Inventory (DCI)
Dyadic coping with 35 items (of 37), 5-point Likert scale (1-5). Min. = 35; max. = 175. Higher scores = better outcome (better dyadic coping)
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University Center of Tumor Diseases, Frankfurt University Hospital
Lead sponsor
Universitätsklinikum Leipzig
Collaborator
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