Design & Procedures.
Eighty-eight patients were randomized to receive either usual care (UC) or a standardized CBI (both are described below). Session one of the CBI occurred at the time of consent or within two weeks (but prior to the initiation of cancer treatment). Follow up CBI sessions were scheduled to coincide with the patient’s HNC clinic visits at approximately two week intervals. A telephone booster session was provided if the interval between the baseline session and initiation of cancer treatment was greater than four weeks. The final CBI session occurred 12 weeks after the initiation of the patient’s cancer treatment and was conducted face to face or by telephone (per patient preference). Study forms (described below) were obtained in both arms of the study at baseline and then at three, six and twelve months post treatment.
CBI Strategy and Procedures. The CBI consists of seven face to face individual sessions, and a telephone booster session if the time between the baseline and initiation of cancer treatment was greater than one month. To maximize treatment consistency, sessions were standardized and provided by the Project Coordinator, an experienced masters’ degree psychotherapist under the supervision of the Co-principal investigator (Co-PI), a licensed clinical psychologist. Sessions were audiotaped and reviewed by the Co-PI for fidelity to the protocol and the Co-PI and the study interventionist met for weekly clinical supervision. The CBI sessions were 45-50 minutes long; the telephone booster session was approximately 20-30 minutes in duration. The CBI sessions were standardized and included the following components based on literature review and clinical expertise:
1. Psychoeducation about depression and mood states common during a cancer experience; including recognizing depressive symptoms, anxiety, and distress.
2. Instruction in the use of cognitive techniques such as cognitive reframe and thought stopping for managing negative and distressing thoughts.
3. Instruction in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, imagery; in vivo practice and a recorded relaxation exercise with instructions for use at home between CBI sessions was provided.
4. Behavioral activation strategies and activity worksheets to increase the patient’s engagement in positive activities;
5. Discussion of patient information and emotional needs and strategies to facilitate communication with health care providers and family/friends; role play and behavioral rehearsal to augment the instruction.
6. Reinforcement of self-care behaviors to manage treatment related side effects (e.g., mouth care, nutritional goals), and behavioral modification of negative health behaviors (e.g., tobacco/alcohol use).
A booster session was conducted at week 12 of the study, face-to-face or by telephone; to reinforce information and strategies presented in the prior sessions. Sessions were standardized (i.e., all the CBI components were included) yet also tailored to each patient’s specific needs. For those patients who were unable to communicate verbally, their responses were either written or mouthed with confirmation of accuracy by the therapist.
Usual Care. Patients in the control group received usual care which included routine contact with the physician and clinic staff. This consisted of patient teaching at clinic appointments with nursing staff, a registered dietician, and intermittent contact with a social worker. Patients received education about cancer treatments, instruction in mouth care, nutritional counseling, care of the feeding tube if one had been placed, and information about clinic and community resources for emotional and social support.
Recruitment.
Participants were identified and recruited by medical, surgical, and radiation oncologists at a multidisciplinary HNC Clinic within an urban academic medical center. All study-related CBI visits were provided at no cost to the patient. To retain participants and enhance compliance, participants who completed week 12 of the study were given a small honorarium ($35). The study was approved by the Institutional Review Board.
Inclusion and Exclusion Criteria. Eligible participants were diagnosed with Head and Neck Cancer as determined by their treating physician, were 18 years of age or older, had not yet initiated treatment for HNC, and had a life expectancy of at least 12 months or greater. Patients excluded had distant metastatic HNC, had a concurrent neurological disorder inclusive of brain metastases which would impair thought, understanding, or compliance with the study protocol, were being treated via medication or therapy for major mental illness (use of an anxiolytic on an as-needed basis was allowed given the high stress associated with a cancer diagnosis), could not read or write English, and/or would be unable to comply with or complete the study because of personal or other medical reasons.
Assessment Measures
All clinical measures were collected at baseline and then at 3, 6, and 12 months post therapy. However, the Cancer Behavior Inventory was not collected at the 6 month period because it measures self-efficacy which is considered to be trait rather than state based and unlikely to change within a short period of time.
Beck Depression Inventory-II (BDI-II). The BDI-II [34] is a 21 item self-report instrument to measure the presence and severity of depressive symptoms. Responses are summed for a total score with higher scores indicating more severity of depression. The inventory has been widely used with medical and nonmedical patients.
Brief Symptom Inventory-18 (BSI-18). The BSI-18 [35] is an 18 item self-report scale that measures current psychological symptoms [36]. Individual items are rated on a 5-point scale of distress and are scored for three subscales (somatization, depression and anxiety) and a global index of distress. The BSI-18 has been used with medical patients, and oncology norms are available based on 1,543 individuals—802 males and 741 females.
Functional Assessment of Cancer Therapy-Head and Neck Version (FACT –H&N). The FACT-H&N [37] is a cancer-specific quality of life tool consisting of a 33-item score (FACT-G) to measure physical, social, emotional, and functional well-being offering a total score and individual subscales; as well as an 11 item subscale specific to HNC concerns [38]. Items are rated on a 0 – 4 scale and are summed for subscales and a total score.
The Cancer Behavior Inventory-Brief Form (CaBI). The CaBI [39] is a 12 item measure of self-efficacy for coping with cancer [43]. Participants rate their level of confidence in various cancer domains on a 9 point scale with higher scores indicating greater confidence. This measure was completed at baseline, 3 and 12 month post therapy.
Demographic and Medical Data Form. Demographic and medical data was collected at every study visit and updated as needed.
STATISTICAL ANALYSIS
Given the design of the study, data from each of the clinical measures was intended to be analyzed with a 2 (group) x 3 (performance at 3, 6, and 12 months into treatment) mixed analysis of variance, controlling for baseline values. As such, the group-by-time interaction would indicate how the trajectory of patients’ functioning and psychological experience differed over time. However, with the substantial attrition that occurred in both groups, tests of significance were not trusted because of low sample size. Instead, the means of each of the variables were calculated, controlling for baseline, and were then visually compared at 3, 6, and 12 months to determine which of the two study groups had the better outcome. Every comparison of group means between the study groups was expressed as a percent difference (i.e., delta percent).