None listed
Conditions
Brief summary
This pilot study aims to explore whether a brief online training program, called Cognitive Bias Modification for Interpretation (CBM-I), is acceptable and feasible and can help reduce fear of cancer recurrence (FCR) in people who have been treated for head and neck cancer. Who is it for? You may be eligible if: You are 18 years or older You have previously been treated for head and neck cancer You are currently experiencing worry or fear about your cancer returning You are not receiving palliative care You can use a smartphone, tablet, or computer with internet access Study details All participants will receive CBMI training. CBM is an intervention that is administered online and trains people not to interpret ambiguous situations in a threatening way. Participants will receive four cognitive bias modification sessions over the duration of 14 days and will be required to answer questionnaires before the trial, and 14, 28 and 84 days after the trial has commenced. It is hoped that this study will help determine if CBMI training is a possible option for treatment of fear of cancer recurrence for those who have previously been treated for head an neck cancer.
Interventions
This is a single-arm pilot feasibility study.
Intervention description:
Cognitive Bias Modification for Interpretation (CBM-I)
We will use pain-related/generic training found to be efficacious for people with moderate-high FCR in breast and ovarian cancer. The ambiguous scenarios paradigm will train participants to make benign interpretations of potentially pain-related situations. Participants will be presented with 30 ambiguous scenarios designed to be interpretively open, each of which could
This is a single-arm pilot feasibility study. Intervention description: Cognitive Bias Modification for Interpretation (CBM-I) We will use pain-related/generic training found to be efficacious for people with moderate-high FCR in breast and ovarian cancer. The ambiguous scenarios paradigm will train participants to make benign interpretations of potentially pain-related situations. Participants will be presented with 30 ambiguous scenarios designed to be interpretively open, each of which could be resolved in a painful or benign manner. Each scenario is followed by a word fragment that participants must resolve. Participants will be instructed to imagine themselves in each scenario. To train people not to make pain-related interpretations, all word fragments will represent benign outcomes. After each scenario, participants will be asked a comprehension question and to indicate whether the question is related to the scenario (‘Yes’ or ‘No’). Participants will then be given feedback that their response is ‘CORRECT’ when they endorsed a benign (not pain-related/non-threatening) response. If participants endorse a painful/threatening resolution, they will be given feedback that their response is ‘INCORRECT’. Example of the scenario used in the task: “You see your grandma, and she tells you she has an appointment with the doctor to look at two spots on her hand. The spots are caused by a_ _e.” The word fragement "a__e" is resovled into acne, demonstrating the non-threatening resolution of the scenario. Comprehension question: Has your grandma been diagnosed with cancer? Yes OR No If a participant chooses ‘Yes’, they will be given ‘incorrect’ feedback, however if they select, ‘No’, they will be provided with a ‘correct’ feedback (as they are endorsing a non-threatening solution). CBM-I will be delivered four times to each participant during the entire study. Time frame: CBM-I training session 1: day 1 of the study CBM-I training session 2: day 4 of the study CBM-I training session 3: day 7 of the study CBM-I (final) training session 4 (FOLLOW-UP 1): day 14 of the study FOLLOW-UP 2: day 84 of the study The number of training sessions completed is recorded for each participant. CBMI will be delivered 4 times to each participant, with each session lasting about 15 mins during the entire study period. Adherence will be automaticaly monitored in the Qualtrics platform for each participant. The word fragement "a__e" is resovled into acne, demonstrating the non-threatening resolution of the scenario.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who have at least moderate levels of FCR (cut-off = 13 and above) 2. Individuals previously diagnosed with any stage or type of HNC (not restricted to mucosal HNC and including squamous cell carcinoma [SCC]). 3. Must have completed active treatment in the past 12-months, with no current evidence of disease. 4. Must be comfortable in English as the intervention is delivered in English and no current translations are available. 5. Have access to the internet and a computer or tablet 6. Aged 18 years or older. 7. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. Individuals with a prior diagnosis of thyroid cancer, melanoma and cutaneous SCC. 2. Those with cognitive impairments that may hinder their ability to participate. 3. Those with serious psychological illness (e.g., psychosis) during the study period. 4. Participants receiving palliative care or in active disease. 5. People who are currently seeing a pain specialist for their cancer-related pain or are currently engaged in a psychological treatment within the past month or have upcoming sessions during the study period.
Outcome results
None listed