Nurse-led telephone follow-up according to the revised nursing outcomes classification for laryngeal carcinoma surgery patients: a randomized controlled trial

The study was a randomized, observer-blinded, two-armed, single-center trial, and all patients were recruited from the Shanxi Key Laboratory of Otolaryngology, Head and Neck Cancer, China. The ethics committee of the Nursing College of Shanxi Medical University (2020sll002) approved the protocol and amendments, and the study’s sponsor (Yongxia Ding) was responsible for data collection. Moreover, every enrolled patient signed an informed written consent form. Patients were randomly assigned to nurse-led telephone follow-up according to the revised NOC (intervention group) or traditional telephone follow-up (control group), with a 1:1 ratio, using a permuted block randomization method. A statistician generated random allocation sequence, and a research assistant enrolled and assigned patients. The details of the revised NOC were reported in our previous study, which contained 14 core postoperative nursing outcomes and 69 indicators [16]. These items were subdivided into physiological health, psychosocial health, health knowledge and behavior, and perceived health; details of this study can be found in Supplementary file 1. Patients completed a questionnaire during their follow-up periods, and follow-up assessments were conducted on both groups six months post the study period [17].

One hundred patients who had undergone laryngectomy were recruited from March 2018‒March 2020. The following inclusion criteria were applied: (1) laryngeal carcinoma confirmed by pathology, (2) treated with total or partial laryngectomy, and (3) patient understands the questionnaire content. Patients with the following characteristics were excluded: (1) recurrence or metastasis of laryngeal carcinoma within six months; (2) cancer at other sites; (3) serious heart, brain, or kidney disorders; (4) mental health issues under treatment; (5) restricted communication ability in terms of speaking, listening, reading, writing, or other forms of communication; and (6) the primary caregiver works in health care.

The general characteristics of patients were obtained from uniform medical records; the information included the patients’ sex, age, educational status, residential location, occupation, marital status, income, smoking history, alcohol history, surgical approach, tube use, and radiotherapy status. The primary endpoint was core nursing outcome scores assessed by the nurse based on physiological health, psychosocial health, health knowledge and behavior, and perceived health [16]; secondary endpoints were quality of life and self-care abilities.

Quality of life after laryngectomy was assessed using the Chinese version of the Functional Assessment of Cancer Therapy–Head and Neck, which was devised by the Center for Translational Research and Education at Northwestern University, USA [18]. The Chinese version of the Functional Assessment of Cancer Therapy–Head and Neck has 5 dimensions and 38 hierarchical items. Each item is scored from 0 to 4, with a total range of 0‒152; a high score for life quality indicates a better quality of life (Supplementary file 2). Self-care ability was assessed using the Chinese version of the Appraisal of Self-Care Agency Scale, which comprises the domains of general self-care skills, developed self-care skills, and self-care skills with poor health status [19]. General self-care skills comprise six items covering a patient’s abilities to maintain the normal and functional integrity of the self. Developed self-care skills are those abilities that are needed under specific conditions and comprise four items. Self-care skills with poor health status comprise five items needed by a patient with a disease or medical issue. Each item is scored from 1 to 5, and high scores indicate better self-care abilities (Supplementary file 3). All of the investigated outcomes were collected before intervention, and at 6 months after discharge through patients hospital revisit. The investigator was trained by the research group to master the concept and evaluation method. The general characteristics questionnaire, quality of life questionnaire, and self-care ability questionnaire were distributed to the patients on the spot and completed by the patients independently. In case participants did not understand the question, the question was explained without being prompted about how to respond. When it was inconvenient for the patient to fill out the form, the investigator would read the item out to the patient, and complete the questionnaire based on the patient’s answer.

Telephone follow-ups were conducted by four specialist nurses, two nursing management graduate students, and two otolaryngology head and neck surgery graduate students assigned to the intervention and control groups. The specialist nurses were registered nurses specializing in otolaryngology head and neck surgery with (1) at least two years of experience, (2) clinical experience with laryngeal carcinoma, (3) an undergraduate college degree or above, and (4) approval to participate in the study and complete the follow-up tasks in the allotted time. Nurses in the intervention group were trained in motivational communication according to the revised NOC [16]. All of the nurses received three training sessions and the duration of each session was 1 h. The follow-up sequence was connect, introduce, communicate, ask and respond, and exit. (1) Connect consists of politely confirming if the person answering the phone is the patient or a family member. (2) The nurse introduces herself and her role and states the purpose of the follow-up. (3) In communicate, the nurse obtains the patient’s consent and cooperation. (4) In ask and respond, the patient is asked the questions from the revised NOC, and the nurse provides health guidance for the patient. (5) Exit consists of the nurse thanking the patient for their cooperation and making an appointment for the next follow-up call.

The details for the questions for the telephone follow-up conducted according to the revised NOC are shown in Supplementary file 4. The traditional telephone follow-up focused on postoperative recovery, answered the questions raised by patients, and provided health guidance without unified and standardized follow-up content. Patients were followed-up at one, two, four, six, and eight weeks after discharge; thereafter, a follow-up call was made every eight weeks, which was consistent with the National Comprehensive Cancer Network and the requirements of follow-up postoperative care [20]. A total of seven calls were made to patients in the intervention and control groups.

The sample size was calculated based on the trial conducted by Malmstrom et al. [21]; 41 patients were required for each group, with α = 0.05 and β = 0.20. Considering a dropout rate of 10%, the sample size needed was higher than 91. Hence, the total sample size in our study was 100 patients. The sample size in this study was calculated with the PASS software, version 11.

The investigated outcomes were assessed before discharge and six months after discharge. Furthermore, categorical data were described by event (proportion), whereas continuous data were shown as mean (standard deviation) or median (quartile) based on whether the data met a normal or abnormal distribution, respectively. The chi-square test was applied to assess the differences in baseline characteristics between the intervention and control groups owing to all variables being categorical data. As the data for nursing outcomes, quality of life, and self-care abilities met a normal distribution, comparisons of these variables before and after intervention in each group were assessed using paired t-tests. Moreover, the mean changes in nursing outcomes, quality of life, and self-care abilities between groups were evaluated using independent t-tests. All P values were two-sided, and P < 0.05 is considered statistically significant. IBM SPSS 19.0 was applied for statistical analysis.