The goal of this study is to compare a Self-Regulation Hypnotic Intervention (SRHI) to the standard procedure (Treatment As Usual with analgesic and sedative agents) for pain and anxiety management during rectal cancer brachytherapy. Hypnotizability of patients undergoing this procedure will be assessed and those who are thought to need analgesic and sedative agents during the procedure will be distributed (sequentially adjusted randomization) in two groups, one that will be trained and assisted using hypnosis and one that will not. Procedural pain, anxiety, difficulty and patients' vital sign will be assessed. Our hypothesis is that patients in the hypnosis group will experience less pain and anxiety and will need less medication than those in the control group.
Research question and Specific Aims: Primary objectives of this pilot Randomized Controlled Trial are to evaluate the effects of SRHI with colorectal cancer patients receiving brachytherapy on: 1) self-reported pain and anxiety levels (measured with a self-report numeric rating scale and facial pain expression) 2) frequency and total doses of administered analgesics and sedatives, procedural length and difficulty and 3) fluctuations of vital signs (heart rate, respiratory rate, pulse oximetry and blood pressure). Ancillary measures will also be taken in order to fuel several future research projects. These include measures of anxiety, depression, personality, quality of life, self-efficacy, and brachytherapy outcome. Since the brachytherapy procedure is new and treats the most prevalent cancer, knowing if hypnosis can be used to ease the experience of patients is important. Unfortunately, research on this subject is scarce. Study Design: Patients deemed eligible for brachytherapy will meet the research assistant (RA) who will explain research consent form and proceed with Mini Mental State Examination. If all inclusion criteria are met, the RA will hand out a package of self-report questionnaires. All participants will be given an appointment for the hypnotizability measure. Participants will all be told that they responded well to the instructions but they will remain blind to their hypnotizability score/performance. Self-report questionnaires and hypnotizability measures must be completed before first brachytherapy session. Eligible participants who are thought to need in-procedure pain and anxiety management will be randomized to a) those who will get the SRHI and b) those who will not (control group). All participants will be told that they would have access to as much medication as they want within safe limits. Hence, we will have a total of two groups: I) the experimental group, participants who receive SRHI and II) participants who will act as the group control for the experimental group and will not receive the SRHI. All participants assigned to the experimental group will meet a psychologist duly trained in clinical hypnosis once for training and will be continually assisted during the intervention (see Intervention section). Hypnotisability measure will be verified by an inter-rater reliability measure. Twenty-five percent (25%) of the administrations will be scored by an independent coder. For the patients in the standard procedure and those in the control group, the medical staff will be instructed to behave naturally the same way they usually do during the procedure in terms of comforting the patient, but to refrain from giving imagery relaxation and hypnotic inductions. Participants of both groups will be administered pharmacological assistance to manage pain and anxiety if they ask for it. All participants will be free to withdraw from the study at any time. The staff will keep track of dosage, type of medication administered and procedural time of administration. The pain and anxiety will be assessed just before the beginning of the procedure, at the insertion of the applicator and every 15 minutes during the procedure. Pain and anxiety levels will also be noted each time the patients ask medication. To ensure that the study is secure and ethic, usual medical interventions will be performed by the chief radio-oncologist if any adverse event occurs. Self Regulation Hypnotic Intervention: The intervention will consist of a modification of a hypnotic relaxation script tailored to fit the unique characteristics of rectal brachytherapy and patients' experience of anxiety, pain intensity and unpleasantness. An experienced psychologist will direct a 40 minutes individual session providing hypnotic analgesia intervention before the brachytherapy procedure. A 10 minutes rehearsal will be done each day prior treatment. Furthermore, the psychologist will deliver the hypnotic intervention during each of the four treatment days. The hypnotic intervention will follow the clinical features (i.e. insertion of the applicator) of the procedure as cued by the treating physician.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
A psychologist specialised in clinical hypnosis teaches patients to use self-hypnosis and guides them through their treatment
Radio-Oncology
Montreal, Quebec, Canada
Pain and Anxiety Self Report
Participant's self-reports of pain and anxiety will be obtained through the use of verbal Numeric Rating Scales (NRS) from 0 (no pain, no anxiety) to 10 (worst possible pain, worst possible anxiety). These scales are currently implemented at the Jewish General Hospital (JGH) , and the NRS for pain is recommended for use in clinical trials and in clinical guidelines for cancer-related pain .
Time frame: Perioperative/Periprocedural
Vital Signs
Vital signs will be continuously recorded with a data collection computer (Moberg Research Inc., USA) connected to the patient's portable monitor (Philips Intellivue MP50) in the brachytherapy room using a serial-port cable, and specific events (i.e., before, during, and after brachytherapy) will be marked. Means of all vital signs will be calculated for one-minute duration at specific times as described in the procedure section.
Time frame: Perioperative/Periprocedural
Facial expressions of pain checklist
Facial expressions of pain will be video recorded during brachytherapy using a behavioral checklist developed by one of the coinvestigator (Céline Gélinas). This checklist is a combination of two previously validated behavioral pain assessment tools i.e. the Pain Behavior Assessment Tool (PBAT;) and the Critical-Care Pain Observation Tool. The Facial Expression section includes 16 dichotomized items (yes/no).
Time frame: Perioperative/Periprocedural
The Hypnotizability Induction Profile
This is a short scale for the measurement of hypnotic responsiveness . The score of hypnotizability trait varies from 0 not hypnotizable to 10 extremely hypnotizable. The HIP takes 5 to 7 minutes to be completed and will be administered on site by a trained research assistant.
Time frame: At recruitment
The Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 has extensive evidence for its validity and reliability in multiple populations. It consists of 8 domains, including physical functioning, social functioning, role limitations related to physical problems, role limitations related to emotional problems, mental health, vitality, bodily pain, and general health perceptions. Each domain can be scored separately, with scores ranging from 0 (the worst health state) to 100 (the best health state). Domain scores can also be summarized into summary scores, scored using norm-based scoring based on a general population sample to produce T scores for each patient (mean of 50 and standard deviation of 10). Version 2 of the SF-36 will be used in this study.
Time frame: Change from Before brachytherapy treatment to one month after surgery
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 and the supplemental for Colorectal 29 (EORTC-QLQ-C30 & EORTC-QLQ-CR29)
This is a 30 + 29-item self-report questionnaire widely used worldwide and validated in 81 languages. It assesses core domains of health related quality of life in cancer patients and specific domains for colorectal cancer patients.
Time frame: Change from Before brachytherapy treatment to one month after surgery
The Patient Health Questionnaire 9 scale (PHQ-9)
This is a nine-item self-report measure of depression severity. Scores of 5, 10, 15 and 20 represent cut offs for the lower limits of mild, moderate, moderately severe and severe depression. A score of 10 or greater is recommended as a screening cut-off point. The PHQ-9 has been shown to be valid and reliable.
Time frame: Change from Before brachytherapy treatment to one month after surgery
The Generalised Anxiety Disorder 7 scale (GAD-7)
This is a seven-item self-report measure of anxiety severity. A score of 10 or greater on the GAD-7 represents a screening cut point for identifying cases of GAD. Similar to the PHQ-9, cut off scores of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7.
Time frame: Change from Before brachytherapy treatment to one month after surgery
The Type D Scale-14 (DS14)
This is a 14-item questionnaire measuring Type D or ''distressed'' personality style, that has been primarily validated among patients with cardiovascular disease. However, this scale has been used with patients with different types of major illnesses and among them patients with colorectal cancer \[38\]. There are two subscales: negative affectivity and social inhibition. Subjects endorse items on a 5-point Likert scale, and those who score 10 points or more on both dimensions are classified as having a Type D personality. Must be validated in Quebec.
Time frame: Change from Before brachytherapy treatment to one month after surgery
The NEO Five-Factor Inventory-3 (NEO-FFI-3)
This is a brief version of the NEO-PI-3 and is composed of 60 self-report items divided into 5 subscales of 12 items each. This questionnaire provides a quick, reliable and accurate measure of the five domains of personality (neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness) and is particularly useful when time is limited and when global information on personality is needed.
Time frame: Change from Before brachytherapy treatment to one month after surgery
Procedural difficulty
The radiation oncologist will rate the difficulty experienced in placing the instrument due to patient movement or resistance using a 4-point scale (1 = not at all difficult, 2 = mildly difficult, 3 = moderately difficult, 4 = very difficult)\[40\].
Time frame: Perioperative/Periprocedural
The Coping with Health Injuries and Problems (CHIP)
This is a 32 item self-report inventory that assesses coping strategies during the development or treatment of a health problem. The items are rated on a five point scale. In psychosocial health research, assessing coping styles is important because coping has been reported to play a mediating role between stress and illness. This inventory evaluates basic coping styles through four different scales: instrumental (Cronbach α ranging between .70 and .82), palliative (α ranging between .72 and .81, distraction (α ranging between .74 and .81) and emotional preoccupation (α ranging between .81 and .88). It takes between five and ten minutes to complete and it has been validated in French-Canadian cancer patient samples. It has also been used in French-Canadian women with breast cancer to assess passive (palliative and emotional combined) and active coping(distraction and instrumental combined), with Cronbach α of .76 and .79, respectively.
Time frame: Change from Before brachytherapy treatment to one month after surgery
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