The Evaluation Of A Home-based Supportive Care Plan For Breast Cancer Patients Receiving Oral Chemotherapy

【Aim】With oral chemotherapy, a home-based treatment, the burden of treatment administration is shifted to the patient, causing greater difficulties in assessing treatment adherence and monitoring of side effects. Because of this change, increased use of oral anticancer therapy introduces a challenge that is faced by health care providers. Our study aimed to develop a home-based supportive care plan for breast cancer patients receiving oral chemotherapy and verify its effectiveness. The specific objectives include 1) describing and exploring the cross-sectional and logitudinal characteristics of home-based supportive care need of breast cancer patients; 2) constructing a home-based supportive care plan for breast cancer patients receiving oral chemotherapy; 3) confirming the effectiveness of the home-based care plan and finally help the patients increase the medication adhe rence, enhance the hope, decrease the disease uncertainty and improve quality of life. 【Methods】A mixed methods design was used. Firstly, a qualitative study was employed to understand the overview of the home-based supportive care needs of patients and the longitudinal characteristics of the needs emerge. Secondly, a home-based supportive care plan based on precise need-orientated mobile intervention was constructed. Finally, a randomised controlled trial was conducted to verify the effectiveness of the home-based care plan.1. Qualitative study of need experiencementWe selected " phenomenological approach " as our research methodology which is one of the qualitative methods in order to understand the needs experience and assessment of breast cancer patients receiving oral chemotherapy among patients, care givers, oncologists, and oncology nurses. A total of 21 participants were recruited according to inclusion criteria in a breast department in a general hospital in Shanghai. Phenomenology is a philosophy, an approach, and a method. Possessed by a reverence for experience, it conforms to nursing’s valuing. Theme analysis was used to interpret the data and summarize the need module and intervention items.2. Longitudinal study of need developmentWe focused on the need experience among different stages and presented the periodical characteristics of the need emerge. A total of 5 breast cancer patients receiving oral chemotherapy were recruited according to inclusion criteria in the breast departments in two general hospitals in Shanghai and Beijing. All the participants were tracked by writing oral chemotherapy diaries. Content analysis was employed to understand the occurrence of themes of need and intervention according to longitudinal research.3. The construction of interventionFirstly, need categories, sub-themes and intervention items were generated and the first draft of intervention modules of a home-based supportive care plan for breast cancer patients receiving oral chemotherapy were formed based on the previous qualitative study. Secondly, Delphi method involving 11 specialists w as used to certify and revise the preliminary intervention plan. Finally, literature research and "content analysis" were adopted to construct the final version of the home-based supportive care plan(intervention design, intervention pattern, intervenor, intervention dosage, intervention content and evaluation index) and standardized intervention dose(intervention component, amount, frequency and period).4. The intervention studyRandomized Controlled Trial was used in the part of intervention study. Firstly, we selected the eligible breast cancer patients receiving oral chemotherapy in the breast departments from three general hospitals in Shanghai, Being and Tangshanfrom 18 th, December,2014 to 31 th, August, 2015. Then they were randomized divided into intervention group(43)and Control group(48). A total of 3 cases in the intervention group discontinued the therapy due to physical status and 1 case in the control group submitted the ineffective questionnaires. Finally, the intervention group patients adopted a home-based supportive care plan with conventional care and the control group patients accepted only conventional care.The effects were evaluated by proper measures(medication adherence, anxiety and depression, hope, disease uncertainty and quality of life before the intervention and in 24 hours after the completion of the home-based supportive carefor both groups. 【Result】1. The result of the qualitative studyFive need categories, twenty-one themes and fifty-four sub-themes related to patients’ need experience and patients’ needs assessment given b y caregivers, oncologists and oncology nurses emerged based on the cross-sectional qualitative study. We classify those themes to five categories for integrating all needs of breast cancer patients receiving oral chemotherapy, which are information need(t reatment, medication, prognosis, diet, rest & exercise, sex and fertility information), safety need(physical and mental safety need), emotional need(love, family, friendship, profession and devotion need), social need(occupation, social network, peer i nteraction and financial support need) and spiritual need(hope promotion, mind peace and self-actualization need).2. The result of the logitudinal studyThrough the period of the cycle 1 and cycle 2 of oral chemotherapy(42 days, 6 weeks), the frequency of occurrence of information need, safety need, emotional need, social need and spiritual need was 559(32.94%), 304(17.9%),250(14.73%),299(17.62%)and 285(16.79%) respectively by analyzing the oral chemotherapy diaries. A specific timeline of the precise need-oriented mobile intervention was developed according to need intensity of each intervention themes.3. The development of the interventionThe final version of a home-based supportive care plan for breast cancer patients receiving oral chemotherapy provided a precise need-oriented mobile intervention, which includes(1)intervention design: randomized controlled trial( RCT);(2)intervention method: short message service(SMS);(3)intervenor: researcher;(4)intervention dosage: one to three times a day, lasting for 2 cycles of oral chemotherapy;(5)intervention contents: meeting the patients’ physical, information, safety, social, emotional and spiritual need.(6)evaluation measures: medication adherence, anxiety and depression, hope, disease uncertainty and quality of life;(7)evaluation time: verified surveys were used before the intervention and in 24 hours after the completion of the home-based supportive carefor both groups.4. The implementation and evaluation for the interventionParallel comparison results show that the scores of medication adherence, anxiety and depression, depression dimension, hope, a cognitive-temporal dimension, affiliative-contextual dimension, uncertainty of disease, complicated dimension, vitality dimension, social function dimension, role emotion dimension, and mental health dimension of quality of life between the two groups existed s tatistical significances(P<0.05). Namely, after the intervention, the intervention group patients’ medication adherence was increased, depression level was reduced,the level of hope, cognitive-temporal and affiliative-contextual dimension intensified, complicated uncertainty of disease decreased, and vitality, social function, role emotion, and mental health were improved compared with the control group patients. 【Conclusion】More and more breast cancer patients have received oral chemotherapy to treat cancer in China. It is essential to explore and construct a home-based supportive care plan and help those patients go through the period of oral chemotherapy smoothly.1.Home-based supportive care needs of breast cancer patients receiving oral chemotherapy were comprehensive, periodical and individulized. Home-based supportive care needs of breast cancer patients receiving oral chemotherapy should not only follow the perception of patients themselves but also hear the voices of other stakeholder groups. Also, we could describe the overview of the need experience by focusing on the logitudinal characteristics.2.A Home-based supportive care plan of breast cancer patients receiving oral chemotherapy was a precise need-oriented mobile intervention. It was conducted via a mobile health platform and realized immediate feedback and effective interaction with patients.3.A home-based supportive care plan of breast cancer patients receiving oral chemotherapy can help the patients increase medication adherence, decrease the lev el of depression and disease uncertainty, enhance the hope and improve the quality of life. The care plan has been proved to be clinically feasible, acceptable and effective after clinical implementation.