Design
This study will take the form of a two-armed non-blinded randomized controlled trial (RCT) and follow the SPIRIT 2013 guidance[17] for designing RCTs.
Study Setting And Recruitment
Patients will be recruited from the oncology outpatient departments and wards of 3 grade 3, class A hospitals, and the Cancer Rehabilitation Association in our city. In the oncology outpatient departments of the hospitals, tumor clinical treatment experts will determine whether the patients are eligible according to the results of patients' return visits. Patients in the Cancer Rehabilitation Association and oncology wards of the hospitals will be determined by nurses experienced in clinical oncology care based on their illness situation. The researcher in charge of recruitment will briefly introduce the purpose, method, and contents of this study to eligible patients. She will listen carefully and answer patients’ questions patiently. If the patient agrees to participate in this study, they will be instructed to sign an informed consent form and complete the baseline survey.
Participants
This study will include patients who: (1) are diagnosed with a malignant tumor; (2) have completed the routine treatment in the hospital without any progress of the disease; (3) have worked before treatment and have not returned to work at present; (4) are aged between 18 and 59 years old; (5) have the ability of reading, writing and understanding; (6) are aware of their illness. Patients will be excluded if they have a cognitive or mental disorder, have other severe co-morbidity, or have also been enrolled in other relevant studies.
Sample Size
The primary outcome measure used in this study was compiled by members of our research group, and we will conduct a pilot study using this scale. When calculating the sample size, PASS 15.0 software will be used, and 20% shedding rate will be considered according to the pilot results.
Randomization
After completing the baseline assessment, participants will be randomly assigned to either the intervention group or the control group at a 1:1 ratio. In this study, an undergraduate medical student will number the patients, use the ‘RANDBETWEEN’ function of Microsoft Excel software to generate a group of random numbers. After sorting the numbers in terms of their size, the first half of the numbers will be coded as ‘1’ and included in the intervention group. The latter half of the numbers will be coded as ‘2’ and included in the control group. The undergraduate student will record the numbers on sticky paper and place them in sequentially coded, sealed, opaque envelopes for safekeeping.
Blinding
For most patients, it will be clear whether they are assigned to the intervention group or the control group. Therefore, it is impossible to blind the patients to their group allocation. However, the randomized procedure outlined above ensures that the allocation sequence will be concealed from the researchers responsible for recruiting patients, data collection, and analysis.
Interventions
Theoretical framework
In the early stage, our research group conducted interviews with 30 cancer patients who had successfully returned to work in-depth with the grounded theory method and constructed the ‘Adaptation Experience and Coping Resource Model for cancer patients to return to work’[18]. This model points out that cancer patients’ adaptability experience to return to work is a process of rebuilding oneself by utilizing superior resources. The adaptation experience includes 3 stages: focus on rehabilitation, rebuild self-efficacy, adjust and plan. The core category is rebuilding oneself. Our group members find that all of these 3 stages run through the entire process of patients’ rehabilitation. Focusing on rehabilitation is the starting point of returning to work and runs through the whole process of returning to work. This process includes healing, introspection and adjustment, and strengthening learning. Rebuilding self-efficacy is the key to a successful return to work, which includes accepting the power of example, feeling emotional support and confidence training. Adjusting and planning are the guarantee for patients to adapt to the working status, including seeking help and planning their careers step by step. Coping resources are divided into personal and external resources. Personal resources include belief, mental resilience, faith, and cognition. External resources include support from family members, professionals, colleagues, employers, and peers. Based on this model and literature review[16], we design the detailed contents of this protocol. We have adopted the advice of stakeholders and experts through structured interviews and Delphi expert meetings, ensuring all helpful information have been incorporated into the evidence-based intervention.
Intervention Group
Implementing this intervention requires the coordination of doctors, nurses, psychological counselors, patients and their family members, peers, leaders, and colleagues. Before the intervention, researchers should adequately communicate with patients, their nurses and doctors in charge, comprehensively evaluate the physiological and psychological conditions of patients, to establish a long-term trust relationship with patients.
Patients in the experimental intervention group will receive a ‘Rebuilding oneself’ intervention. This intervention includes 3 themes and 16 face-to-face or online courses. During the intervention, researchers will keep in touch with patients by telephone or WeChat to ensure they participate in this study as much as possible. In this study, researchers will provide patients with multidisciplinary rehabilitation guidance with the purpose of improving patients' self-management ability and self-efficacy, encouraging patients to make adjustments and occupational plans. The form of intervention will depend on patients' preferences, and individualized intervention doses will be determined according to patients' conditions and needs. The total time of the intervention is 3 months. Meanwhile, researchers should dynamically assess patients’ physical and mental health status, flexibly adjust the intervention contents and supplement with psychological counseling when necessary. In addition, researchers should promote the intervention contents of three themes at the same time to help patients balance physical, psychological and social health and better achieve full recovery. The detailed contents of this intervention are described below (Table 1).
Table 1
The detailed information of the intervention
Themes | Objectives | Contents | Methods |
Focus on rehabilitation | 1. Understand the importance of returning to work. 2. Master the knowledge of physical and mental rehabilitation and self-management methods. 3. Implement the self-management plan. | 1. Encourage patients to express their views on returning to work, communicate with patients about the positive significance of returning to work, and help them build their belief in comprehensive recovery. | Individual communication and interview |
2. Carry out health education actively, and give out health education leaflets. Encourage patients to strengthen their study, master the knowledge of cancer recovery and keep a good attitude. | Individual communication and interview |
3. Guide patients to reflect on factors that are detrimental to their physical and mental recovery (such as bad living habits, environmental factors, personality defects, et al.), discuss targeted solutions with patients, and seek support from peers, family members, and medical staff when necessary. | Individual communication and interview |
4. Ask patients' healthcare providers about their health status and help them develop a self-health management plan. | Individual communication and interview |
5. Sign rehabilitation contracts with patients to enhance their compliance with health management. | Individual communication and interview |
Rebuild self-efficacy | Be familiar with ways to improve self-efficacy. | 1. Understand the views of the patient's family members, peers, leaders, colleagues, and medical staff on patients’ illness and their return to work, and help them establish a correct view of rehabilitation. | Individual communication and interview |
2. Inform the patient's family members, peers, leaders, colleagues, and medical staff of the importance of their care and support for their returning to work and complete recovery, and encourage them to offer their support. | Individual communication and interview |
3. Understand the condition of patients' discussions with their family members, peers, colleagues, leaders, and medical staff about returning to work, ask them about their concerns and confusion on returning to work, and discuss solutions with patients. | Family meetings |
4. Encourage patients to perceive the support from their own beliefs, family members, leaders, colleagues, peers, medical workers, and other aspects, record it in the diaries and review it regularly to constantly firm their belief of comprehensive recovery. | Individual communication and interview, write diaries |
5. Guide patients to find examples of ‘role models’ who have successfully returned to work after cancer, and share the experience and positive energy gained. | Thematical communication |
6. Encourage patients to share their experiences of overcoming difficulties and achieving success in the past and the insights gained from them. | Thematical communication |
7. Self-confidence training: | |
① Positive psychological suggestion training: urge patients to smile to themselves every day, repeat positive words, and give patients timely affirmation and praise. | Classes |
② Mental resilience training: teach patients common stress coping skills, encourage patients to face pressure actively, and guide them to solve problems by clarifying and understanding issues, breaking complex problems into small steps, proposing solutions, and summarizing issues. | Classes |
③ Patients are encouraged to gradually adjust their daily work and rest, and gradually integrate with the daily work and rest of the working stage. | Individual communication and interview |
④ Encourage the patient to do things related to work gradually. | Individual communication and interview |
Adjust and plan | Achieve the goal of returning to work gradually. | 1. Invite medical staff to make scientific decisions on the appropriate time, position, and workload for patients to return to work according to their conditions. | Individual communication and interview |
2. Based on the advice of the medical staffs, ask patients about communication with their family members, peers, leaders, colleagues, etc., and urge the patient to actively seek support for returning to work if necessary. | Individual communication and interview |
3. Ask the patient about his/her work goal, discuss with him/her appropriate career goals according to his/her recovery condition, make a gradual career plan, and evaluate the relationship between health and work. | Individual communication and interview |
4. Summarize the contents of this intervention protocol to enhance the adaptability of returning to work. | Individual communication and interview |
Control Group
Patients in the control group only received usual care, and we will provide personalized reexamination and matters needing attention during healing to patients through WeChat. Meanwhile, patients can also ask questions about rehabilitation to our team members through WeChat, and we will answer them patiently one by one. In this way, we can also keep in touch and establish a relationship of trust with the patient, as well as reduce the patient’s loss rate. Similarly, patients in the intervention group will receive this usual care in addition to the ‘Rebuilding myself’ intervention.
Assessment Of The Outcomes
Sociodemographic data
The following sociodemographic data will be measured in the form of questionnaires at baseline: gender, age, marital status (married, single, widowed, divorced), education (primary school or below, junior high school or technical secondary school, senior high school or junior college, undergraduate, master degree or above), place of residence (rural, town, city), religious beliefs (yes, no), occupation before illness, medical insurance, cancer diagnosis and stage, treatment (surgery, radiotherapy, chemotherapy, other).
Effect Evaluation
The primary outcome measure is the adaptability of cancer patients to return to work[19]. This scale was compiled by members of our research group, and has good reliability and validity. The Cronbach's α coefficient of the total scale is 0.973. This scale includes 24 items in 3 dimensions, focus on rehabilitation (6 items), rebuild self-efficiency (9 items), adjust and plan (9 items). Each item is rated on a 5-level scale, from ‘disagree’ to ‘strongly agree’. A higher total score indicates a higher level of adaptability of patients to return to work.
The secondary outcome measures are self-efficacy of returning to work, mental resilience, quality of life and work ability.
The Chinese version of the Return-to-Work Self-Efficacy Questionnaire [20] evaluates patients' self-efficacy of returning to work. The Cronbach's α coefficients of this scale range from 0.90 to 0.96. The scale contains 11 items in total (items 2, 6, and 9 are reverse scoring), and adopts the Likert 6-level scoring method. A score from 1 to 6 indicates ‘completely disagree’ ‘disagree’ ‘slightly disagree’ ‘slightly agree’ ‘agree’ and ‘completely agree’ successively. The average score of 11 items is used to calculate the score of the Return-to-Work Self-Efficacy Questionnaire, and a score higher than 4.5 indicates that the patient has an increased sense of self-efficacy in returning to work.
The Connor-Davidson Resilience Scale[21] measures the mental resilience of cancer patients. Chinese scholars adjusted the scale into 3 dimensions: tenacity (13 items), strength (8 items), and optimism (4 items). Its cronbach's α coefficient is 0.89, and the retest reliability is 0.87. This scale adopts the Likert 5-level rating method, and 0 ~ 4 points respectively mean ‘never’, ‘rarely’, ‘sometimes’, ‘often’, and ‘always’.
The Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30[22] measures the quality of life of cancer patients. It has 30 items, which can be divided into 15 dimensions: 5 functional dimensions (physical, role, cognitive, emotional and social function), 3 symptom dimensions (fatigue, pain, nausea, and vomiting), 1 general health/quality of life dimension and 6 single items (shortness of breath, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). This Chinese scale has been proven to have good reliability, validity, and reactivity.
The Chinese version of Work Ability Index questionnaire[23] determines whether a person can be competent at their job. The scale measures patients' physical and mental demands on a range of positions, their health, and mental resources. The higher the patient's score, the better ability he/she have to do the job.
Data Collection And Analysis
Data to evaluate the intervention are collected at baseline, during the 6th week, and after the 12th week of the intervention via a self-completion questionnaire. The data will be collected by an investigator who is not involved in either the implementation of the intervention or the analysis of the data. Statistical analysis will be carried out using SPSS 26.0. The level of statistical significance will be set as α = 0.05. Descriptive analyses, including percentages, means, and standard deviations, will describe sociodemographic and outcome variables. T-tests or the Mann-Whitney U test for quantitative variables and chi-square tests for categorical variables will be used to compare the baseline characteristics and effective outcome measures of the 2 groups. What’s more, per-protocol and Intention-to-treat analyses will be used to evaluate the effectiveness of the intervention because of possible patient culling and shedding.