ACT for Distress in Head and Neck Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02840071|
Recruitment Status : Not yet recruiting
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
|First Submitted Date ICMJE||July 12, 2016|
|First Posted Date ICMJE||July 21, 2016|
|Last Update Posted Date||July 21, 2016|
|Study Start Date ICMJE||October 2016|
|Estimated Primary Completion Date||March 2017 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||ACT for Distress in Head and Neck Cancer Patients|
|Official Title ICMJE||Acceptance and Commitment Therapy for Individuals With Head and Neck Cancer Experiencing Psychological Distress: A Hermeneutic Single-Case Efficacy Design|
Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer Experiencing Psychological Distress.
Head and neck cancer (HNC) patients are particularly vulnerable to experiencing psychological distress . The current guidelines from the National Institute of Health and Care Excellence are that cognitive-behavioural therapy (CBT) is to be offered to adults with a long-term physical health condition experiencing anxiety and depression. CBT has been shown to have several inadequacies for individuals with physical health conditions such as cancer. Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming to change a person's interaction with their thoughts rather than suppress or alter thought content. Although studies indicate encouraging findings for the effectiveness of ACT for individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and there is a need to evaluate the replicability of ACT effects in people living with HNC, given the unique challenges inherent to the disease and its treatment.
This study aims to inform clinical practise by using a hermeneutic single-case efficacy design (HSCED) to answer the following questions:
The study will involve recruiting three adults with HNC from specialist HNC psychology services. Each participant will have six individual sessions of ACT and complete various process and outcome questionnaires during sessions. Following the intervention, participants will have a semi-structured interview where their views of the therapy and any changes made will be explored. Two outcome measures will be posted to participants at 1-month and 3-month post intervention.
This study aims contribute to the theoretical literature on acceptance and commitment therapy (ACT) as well as the processes of psychological change for patients with head and neck cancer (HNC). Unlike some other cancer sites, the physical and emotional impact of living with HNC can be detrimental to the fundamental aspects of an individual's life (such as breathing, eating, hearing), and also cause significant changes to physical appearance. This forms the basis for specialised research of HNC patients. There is a tendency within the current cancer literature towards researching and understanding and other types of cancer or grouping HNC patients into heterogeneous cancer samples, leaving an evident gap of knowledge. Studies that have assessed the effectiveness of ACT mirror this trend, using either breast cancer or heterogeneous cancer samples.
Employing a single-case method with both quantitative and qualitative components will give a more precise understanding of the processes within ACT that are helpful and most importantly, why. This may have direct implications for informing the on-going practice of professionals working therapeutically using ACT, enabling them to refine interventions and focal principles. In support of this, a recent review of ACT interventions concluded that although efficacy of ACT is probable, there is a lack of knowledge of how it works. Single-case research is a pragmatic first step in exploring the efficacy of ACT for HNC patients and increasing understanding of the potential mechanisms of change. A Hermeneutic Single Case Efficacy Design for three participants will be used. This is a legalistic single case study method which allows the assessment of intervention effects in single therapy cases within a naturalistic clinical context. It uses a mixture of qualitative(change interview) and quantitative methods (questionnaires) to create a set of evidence that allows detection of causal links between therapy process and outcome.
In order to minimise the risk of coercion, a member of the patients care team (Clinical Psychologist) will be the first point of contact for potential participants, introducing waiting-list patients to the research and giving them the information sheet if they verbally indicate interest. After reading the information sheet, if they verbally agree to continue with the research, they will be put into contact with the researcher who will answer any additional questions, ensuring that the person has sufficient time to consider participating or not. Written informed consent will be collected from each participant before they undergo any intervention related to the study. One copy of this will be kept by the participant, one will be kept by the researcher, and a third will be retained in the patient's hospital records.
Informed consent will be gained in accordance with the Research Ethics Committee (REC) guidance, and Good Clinical Practice (GCP) and any other regulatory requirements that might be introduced. The researcher and the participant will both sign and date the informed consent form before the person can participate in the study. The researcher will emphasise to them that consent regarding study participation is entirely voluntary and may be withdrawn at any time without penalty or affecting their care. For example, if the patient withdraws from the study, they will return to the point of the psychological therapy waiting list that they were taken from, therefore not affecting the length of time they have to wait to see a therapist. There will be no monetary incentive to take part in the research, reducing the risk of coercion.
This research aims to use a sample most representative of individuals in clinical practice, therefore site and stage of HNC does not feature the inclusion criteria. The GAD-7 (generalised anxiety disorder) and PHQ-9 (patient health: depression) questionnaires will be used using 'caseness' thresholds for anxiety and/or depression as these are widely used and the current screening method for most psychology therapy services.
In order to ensure confidentiality, identification code numbers will be assigned to correspond to treatment data. All study researchers will endeavour to protect the rights of the participants to privacy and will adhere to the Data Protection Act, 1998. Only the minimum required information for the purposes of the study will be collected. Participant information will be held securely, in a locked room, or locked cupboard or cabinet. Access to the information will be limited to the study staff and investigators. Computer held data including the study database will be held securely and password protected. All data will be stored on a secure dedicated web server. Access will be restricted by user identifiers and passwords (encrypted using a one way encryption method). Information about the study in the participant's medical records / hospital notes will be treated confidentially in the same way as all other confidential medical information.
There are no likely risks for participants taking part in the study, other than iatrogenic effects that are a possibility with any psychological therapy. These include: increased insight into difficulties causing an increase in psychological distress and psychological discomfort talking about physical and psychological distress. These risks would be monitored throughout therapy using the standardised measures and clinical observations. If these risks appear to be occurring, the chief investigator will be notified and the service safeguarding protocols will be followed, as patients will remain under the HNC psychology service during the course of the research.
There are several potential benefits to participants taking part in this research as suggested by the ACT cancer literature: reduced psychological distress, increased psychological flexibility and improved quality of life. As the researcher is also the therapist, any potential conflict of interest will be managed by using fortnightly clinical supervision with a psychologist, having a random 20% of the the audio recorded sessions viewed by a specialist ACT psychologist and having an independent researcher to carry out the change interview.
After receiving informed consent the study procedure will be as follows:
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Other: Psychological therapy
Acceptance and commitment therapy is a third-wave cognitive behavioural therapy. The aim of ACT intervention is to increase a person's psychological flexibility by enabling them to change their relationship with distressing cognitions (acceptance) and doing things that are personally meaningful to them (commitment). The ACT model does not focus on distress reduction, although this is a secondary consequence of acceptance and commitment. This is targeted through the six core processes: present moment awareness, cognitive defusion, acceptance, self-as-context, values and committed action which means taking effective action, guided by the identified values. The intervention will involve six 1.5 hourly individual sessions.
|Study Arms||Experimental: Intervention
Intervention: Other: Psychological therapy
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||March 2017|
|Estimated Primary Completion Date||March 2017 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Participants taking part must:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT02840071|
|Other Study ID Numbers ICMJE||16067|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||
|Responsible Party||University of Nottingham|
|Study Sponsor ICMJE||University of Nottingham|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of Nottingham|
|Verification Date||July 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP