Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors

Study Overview
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Brief Summary
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The main purpose of the study is to evaluate the feasibility, acceptability, and potential effectiveness of NET in reducing symptoms of traumatic stress (e.g., hyperarousal, avoidance, and intrusion) in cancer patients who are not in active treatment. Further aims include: Can NET be effective in reducing symptoms of existential anxiety, anxiety, and depression in cancer patients who are not in active treatment? Can NET improve the Quality of Life (QoL) of cancer patients who are not in active treatment? And are improvements in QoL associated to reduction of traumatic stress? Can NET lead to post-traumatic growth? Does the NET protocol need to be adapted to meet cancer patients' needs?

Detailed Description
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Research has shown that cancer can lead to significant emotional and social distress. Many elements of the cancer experience can be perceived as traumatic by cancer patients, including diagnostic testing, waiting periods, prolonged and invasive treatment procedures, follow-up scans, and fear of recurrence. Unlike single traumatic events, cancer behaves as an ongoing and chronic stressor. Emotional and social distress (including anxiety, depression, and post-traumatic stress disorders), can lead to reduced treatment compliance and less adherence to a healthy lifestyle which might compromise chances of survival. Research has shown that due to the psychological distress experienced during diagnosis, treatment, and survivorship, cancer patients are interested in receiving psychosocial support; unfortunately, their distress is often perceived as normal and manageable by professionals. The result is that 30-40% of cancer patients are not supported. This study aims to evaluate whether Narrative Exposure Therapy (NET) can be a feasible, acceptable, and effective intervention to reduce symptoms of traumatic stress in adult cancer patients who are not in active treatment. NET is a time-limited, structured, and evidenced-based intervention designed to reduce symptoms of traumatic stress through two main processes: fear habituation and integration of the traumas within the autobiographical memory. Six participants will be recruited with the support of Clinical Psychologists working in cancer services across Nottinghamshire and Lincolnshire, they will receive around twelve weekly interventions sessions. Changes will be explored through outcome measures administered before, during, and after the intervention and through interviews about their experience at the end. The study is founded by The University of Nottingham. Potential benefits include providing initial evidence to address traumatic stress in cancer patients, providing an intervention which could be suitable for psycho-oncology services which might lack resources to offer long-term psychosocial support, and contributing to the evidence for the use of NET in a new group.

Official Title
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Investigating the Application of Narrative Exposure Therapy (NET) to Reduce Symptoms of Traumatic Stress in Cancer Patients Not in Active Treatment: a Naturalistic Single Case Study Series

Conditions
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Traumatic Stress Disorder, Cancer

Intervention / Treatment
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* Other: Narrative Exposure Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 and over) Diagnosed with cancer in adulthood Able to provide informed consent Able to communicate verbally and speak English Not in active treatment (at any stage post-treatment) Suffer from symptoms of traumatic stress caused or triggered by the cancer experience. A diagnosis of PTSD is not required (PTSD Checklist Civilian, PCL-C cut-off score: 29 and above). No specific form of cancer Exclusion Criteria: Participants have a known diagnosis of Intellectual Disability (ID) Participants must not be receiving other forms of psychosocial support whilst engaging in NET They are substance dependent They are actively psychotic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Naturalistic, mixed-method, explanatory sequential measurement single case series design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrative Exposure Therapy<br>This is a single case series design which focuses on assessing whether Narrative Exposure Therapy could reduce symptoms of traumatic stress in cancer survivors; no comparator will be included. | Other: Narrative Exposure Therapy<br>* NET (Schauer et al., 2011) is an evidence-based, short-term, manualised treatment for trauma-spectrum disorders; it aims to reduce symptoms of traumatic stress in individuals who continue to suffer from past experiences of traumatic stressors; NET combines principles of CBT, Testimony Therapy, and Exposure Therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTS symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by thePTSD Checklist - Civilian (PCL-C; Weathers et al., 1994) | The PCL-C explores items related to individuals' past stressful experiences using a 17-item self-report checklist (Weathers et al., 1994). The PCL-C has been widely used in cancer research (such as DuHamel et al., 2010; Levine et al., 2005; Lleras de Frutos et al., 2020; Ochoa-Arnedo et al., 2020) and was assessed as a screening instrument by Andrykowski and colleagues in their study with breast cancer survivors in 1998. The PCL-C has shown good internal consistency (Cronbach's alpha >.75) (Wilkins et al., 2011) and good test-retest reliability with scores ranging from 0.68 and 0.92 (Hahn et al., 2015). Scores above 29 are indicative of clinical concerns; the US Department of Veterans Affairs recommends a cut-off score of 30 to 38 for diagnosis of PTSD (www.ptsd.va.gov). | Throughout the study, for approximately 31 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression and anxiety symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed byHospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) | The HADS is the most extensively studied mood scale in cancer services (as well as in other medical settings) (Mitchell et al., 2010). It is a fourteen item self-report measure of anxiety and depression that has demonstrated to be psychometrically robust showing good internal consistency (Anxiety Cronbach's alpha = .83; Depression Cronbach's alpha = .82) (Bjelland et al., 2002) and good test-retest reliability (Anxiety r = .82; Depression r = .52) (Martin & Thompson, 2002). Scores of 8 and above are indicative of clinical concerns. | Throughout the study, for approximately 31 weeks | 
| Change in cancer-specific quality of life between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by the Functional Assessment of Cancer Therapy - General 7 items (FACT-G7; Yanez et al., 2013) | The FACT-G7 is a brief, cancer-specific quality-of-life measure comprising 7 items from the 27-item Functional Assessment of Cancer Therapy-General Scale (FACT-G; Cella et al., 1993) that were endorsed by cancer patients as being of highest priority. Its items comprise physical, emotional and functional domains. Total scores range between 0 and 28, and higher scores indicate better quality of life. The FACT-G7 has shown good internal consistency (Cronbach's alpha = between .72 and .80) (Mah et al., 2020) and good test-retest reliability (scores between .52 and .74) (King et al., 2020). | Throughout the study, for approximately 31 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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narrative exposure therapy