This study was a two- group before- after randomized controlled trial to evaluate the effects of implementing continuous care model on body image in breast cancer patients undergoing chemotherapy. The study was consent by the ethics council of Ahvaz University of Medical Science. In this study, patients with Breast cancer who referred to the chemotherapy clinic of Ahvaz University of Medical Sciences in 2013, and complied the entry criteria were selected. They were ages 25 - 65 years old, a desire to take part in the study, ability to fill in the study questionnaire, no history of psychiatric disorders or amnesia, Persian as their first language, involvement in stages 2 - 4 of breast cancer, and attending at least one and at most 5 chemotherapy sessions. Patients who had been hospitalized or did not wish to continue the study were excluded. Patients having the entry criteria entered the study after complementing the informed consent form. Sample size was calculated after conducting a pilot study on 20 patients (α = 0.05 and β = 0.2) as 78 subjects. Subjects were selected in pairs among identical subjects concerning age, type of surgery and education level, and then, they were assigned to the study and control groups through random allocation (a coin toss).
Data was collected via questionnaires before and 2 months after the intervention. The first questionnaire was about demographic information (like age, education level and marriage status), job, smoking status, history of other diseases and history of cancer in the family. The second instrument was Hupwood et al. body image scale (BIS) (2001) (
1). This checklist, distributed among 276 English patients with cancer, showed an appropriate validity among cancer patients (α = 0.93) (
11).
It contains 10 items in cognitive, affective and behavior domains, which are scored 0 - 3 (normal, slight problem, moderate problem and acute problem) with total score of 0 - 30.
Higher scores show more body image disturbance. Scores between 0 - 10 show minor body image disturbance, 11 - 20 show moderate and 21 - 30 show severe body image disturbance. Split half method was adopted for BIS reliability so that the questionnaire was completed by 20 breast cancer patients undergoing chemotherapy in two time points with a week interval and Pearson correlation coefficient of r = 68% was obtained.
Then, four days after chemotherapy session, the subjects were given BIS. Next, the educational program with help of continuous care model was designed. This model was conducted for two months.
In the control group, the usual cares were applied. The continuous care model was performed in 4 stages.
1. Orientation: The first step of this model was acquaintance with the goal of the relationships with the client, enticing her cooperation to participate in the research, and motivating the exigency of continuous care in the client.
2. Sensitization: the second step was sensitization simultaneously with orientation; concentrate on client to embrace her health accountability. In this step, all of the patients’ educational demand was evaluated and the needful descriptions about breast cancer, chemotherapy and their complications, the necessity of continuous care, and the importance of body image reclaiming were stated in 45 - 60 minutes sessions. Also the team of researchers prepared an educational pamphlet for easily understandable facts about chemotherapy, its complications and self-care programs such as regular exercising, nutritional diet and relaxation training. The 1st and 2st steps were accomplished by importing the patient and one of her family member to encourage and take part in body image improving. These steps were accomplished at the first 2 weeks of the total period of model performing (8 weeks).
3. Control: This step contains the scrutiny and strength of care that took place. Six weeks were assigned to this step during which the individual and group consultation (in the form of three ten- and one nine-person groups), speech and question - answer sessions ( about the kind and feature of patient/family needs and problems) were done at Ahvaz Shafa hospital clinic. The number of sessions based on the level of awareness, intensity and the number of problems for any subject. On average 2 - 3 meetings of 1 - 2 hours long were held for every group. Then continuous care advisement was done daily and weekly, according the need types. The researcher phone number was given to patients for their probable questions.
4. Evaluation: this 4th (final) step of continues care model was considered from the onset of all steps. Its aim was the evaluation of care process and it ascertains and supervises the patient's behavior while being followed by the researcher.
The accumulated data were analyzed by SPSS (version 16.0), using T-test and chi-square. In this study, the significance level was considered at 0.05.
Ethics committee of Ahvaz University of Science approved the study (ajums.REC.1392,36). Moreover, the Iranian registry of clinical trials approved and registered this study (the registration number was IRCT2013070613802N2).