|Ahead of print publication
Brief psychological intervention among treatment-seeking cancer patients: A randomized controlled trial
Reena Rani1, Jaison Joseph2, Rakesh Dhankhar3
1 Department of Psychiatric Nursing, College of Nursing, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India
2 Department of Psychiatric Nursing, College of Nursing, Rohtak, Pt. B. D. Sharma University of Health Sciences, Haryana, India
3 Department of Radiation Oncology, Regional Cancer Centre, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana, India
|Date of Submission||03-May-2021|
|Date of Decision||09-Aug-2021|
|Date of Acceptance||20-Jan-2022|
College of Nursing, Pt. B. D. Sharma University of health Sciences, Rohtak - 124 001, Haryana
Source of Support: None, Conflict of Interest: None
Background: Cancer is one of the major leading causes of death, and psychological interventions are found to be helpful to reduce the distress related to the disease. The study investigated the effect of nurse-led brief psychological intervention among treatment-seeking clients with head and neck and breast cancer. Methods: This study is a randomized controlled trial, in which a total of 80 subjects were consecutively recruited using block randomization method and as per the sampling criteria. A trained nurse delivered a 30-min individual-based brief psychological intervention and the subjects in the control group received the usual hospital care. The outcome measures were changes in quality of life (QoL) and psychological distress based on the Hindi Version of Functional Assessment of Cancer Therapy-General and DASS-21 during a 1-month follow-up. Results: The mean age of the sample was 52.68 (standard deviation = 10). The study observed a significant improvement in the overall and separate domains of QoL (P < 0.01) and reduction of psychological distress (P < 0.01) in the intervention group as compared to the control group during the 1-month follow-up. Conclusion: The nurse-led brief psychological intervention may be an effective strategy for improving the QoL and reducing the psychological distress in treatment-seeking cancer individuals in this setting. Considering the short-term effect of this clinical intervention trial, more studies should be conducted in similar settings for an evidence base to advocate supportive nursing care practices in the routine oncology clinical setting.
Keywords: Brief psychological intervention, cancer patients, nurse
|How to cite this URL:|
Rani R, Joseph J, Dhankhar R. Brief psychological intervention among treatment-seeking cancer patients: A randomized controlled trial. Med J DY Patil Vidyapeeth [Epub ahead of print] [cited 2022 Dec 7]. Available from: https://www.mjdrdypv.org/preprintarticle.asp?id=338621
| Introduction|| |
Cancer is a major public health issue and is the second leading cause of death worldwide with an estimated 18.1 million new cases and 9.6 million cancer deaths in 2018. According to the WHO, one in six deaths is due to cancer. Cancer prevalence in India is estimated to be around 2.25 million, with over 1,157,294 lakh new patients and 784,821 total deaths were reported in 2018 due to this disease in the country. India has one-third of oral cancer cases in the world. Among Indian women, breast cancer is the most common cancer accounting for 27% of all cancers.
There has been achieved great advancement in the treatment for cancer, including surgery, chemotherapy, radiotherapy, or the combination of all 3 methods. However, more or less some side effects (such as tiredness, loss of appetite, anemia, and alopecia) are induced by these treatment modalities and cause feelings of depression, anxiety, worthlessness, or suicidal ideations in the patients. These physical and psychosocial problems contribute to reducing their health-related quality of life (QoL)., The findings of several studies have revealed that QoL is an excellent predictor for prognosis, where the reduced QoL is directly proportional to the shorter survival time.,, Thus, how to improve the QoL has been one of the most important concerns for patients with cancer.
Patients with cancer are known to have specific psychological needs related to the progression of the disease and the impact of their treatment. The most common psychological problems of individuals with a diagnosis of breast cancer and head and neck cancer are depression, anxiety, and fear of cancer recurrence., The psychological distress in head and neck cancer patients may be associated with their facial disfigurement and body image disturbances. Radiotherapy or surgery on the tongue or the mouth or the larynx can change the shape of the face and alter a person's ability to communicate with others, resulting in reduced self-esteem, QoL, and thus increases the risk of depression and anxiety. The empirical evidence suggests that women with breast cancer may experience feelings of vulnerability related to their changed body image, sexual dysfunction, marital or partner-specific issues, and treatment-related physical and social impairment such as fatigue and menopausal symptoms.
A systematic assessment and interventions to support these issues are of paramount importance. The existing review suggests three components of cancer-related psychological interventions. The first component includes patient-tailored psychoeducation on disease progress and treatment, side effects of chemotherapy, and symptom management. Second, coping strategies are based on the concepts of cognitive behavioral therapy (CBT) and stress management techniques. The third is ensuring emotional support from the family and treating team. Evidence-based interventions have proven effective in reducing psychological distress and improving QoL among cancer survivors. The recent systematic reviews identified that the following type of psychological interventions was tested among cancer patients. This includes CBT, psychoeducation, meditation/mindfulness, group therapy, and telehealth initiatives.,, The available literature suggests nurses as brief psychological intervention therapist in various settings such as substance abuse and primary health-care setting.,, Nurse-conducted brief psychological intervention has substantiated to be effective in reducing psychological distress, symptom management, improving coping with physical impairment, and reducing emotional distress of treatment-seeking cancer population. However, the majority of the relevant studies were found to have serious methodological limitations restricting the implementation and dissemination of these interventions in clinical practice.
There is limited literature from India examining the effectiveness of nurse-conducted brief psychological interventions in cancer patients. The present study aimed to determine the effectiveness of a nurse-conducted brief psychological intervention among treatment-seeking head and neck and breast cancer patients.
| Methods|| |
The study is a randomized controlled trial (RCT) conducted at the Regional Cancer Centre, PGIMS, Rohtak, India. The study was approved by the Institutional Ethical Committee, Pt. B. D. Sharma Postgraduate Institute of Medical Sciences, University of Health Sciences, Rohtak (Ref No. BREC/19/106 dated 11/12/2019). One nurse with a postgraduate degree in psychiatric nursing was involved in the brief psychological intervention. Informed consent was obtained from all the study participants, and confidentiality was maintained throughout the study. The outcome measures were changes in QoL and psychological distress measured as per the Hindi Version of Functional Assessment of Cancer Therapy-General (FACT-G) and DASS-21. Clients with head and neck cancer and breast cancer were the most common treatment-seeking cancer population as per the study setting. Therefore, the study included clients who were currently undergoing treatment for head and neck and breast cancer such as chemotherapy and radiation. Clients who had difficulty participating in a session and not able to read and write the Hindi language were excluded.
Sample size calculation
The sample size calculation was based on the outcome of a previous study on nurse-led psychological intervention program investigating QoL and psychological distress among clients with breast cancer. Using 80% power and 95% confidence level, a minimum of 70 subjects were calculated. Assuming a 10% attrition rate, the sample size was estimated as 77 and rounded off to 80.
Randomization and allocation concealment
Block randomization was used for ensuring equal distribution of participants as per the diagnosis and the treatment condition. A total of 8 blocks with a block size of 10 was determined. The number of blocks was stratified as per the diagnosis (i.e., 4 blocks for each head and neck and breast cancer), and the block sizes were equally created as per the treatment status (i.e., 5 for intervention and 5 for the control group). The allocation of groups into intervention and control groups was ensured using sequentially numbered sealed envelopes. The nature of the intervention was written on paper and kept in a sealed envelope. The envelope was labeled with a serial number. The principal investigator opened the sealed envelope once the patient has consented to participate and then assigned the group accordingly. Hence, the eligible subjects were divided into four groups: head and neck control group and breast cancer control group and head and neck intervention group and breast cancer intervention group with 20 subjects in each group forming a total sample of 80. The present study explored the feasibility of brief psychological intervention in the routine outpatient visit. Considering the average daily census and the imposed time limitations, blinding was not possible and the principal investigator enrolled the participants and assigned to interventions accordingly.
All the eligible subjects available during the period of data collection were enrolled consecutively as per the sampling criteria. A total of eighty participants were recruited through a referral from the oncologist. None of the subjects refused to participate in the study. After the selection of participants, sociodemographic and clinical characteristics of the subjects were collected. Besides, the outcome measure questionnaires were administered to both groups of participants before randomly allocating them to either the intervention or control group. The control group received the routine care of review and advice from an oncologist. Apart from the routine care, the nurse-led brief psychological intervention was offered to those in the intervention group. All participants recruited through a referral from oncologists were eligible and consented for preassessment and completed their 1-month follow-up [Figure 1].
QoL was assessed using the Hindi version of FACT-G which consists of 27 questions from 5 different domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. Each question has a set of responses, whose score ranges from minimum 0 to maximum 4. The total FACT-G score is the summation of the 4 subscale scores and ranges from 0 to 108. The current study used the Hindi version of FACT-G obtained from the original developer (official website-https://www.facit.org). The FACT-G questionnaire in Hindi is found to be a useful and valid tool in measuring QOL of cancer patients in the Indian setting.
DASS-21 is a shorter version of the 42-item questionnaire which measures psychological distress in three dimensions: depression, anxiety, and stress. A score of 0–9, 10–13, 14–20, and 21–27 was considered normal, mild, moderate, and severe, respectively, for the depression component. For the anxiety component, a score of 0–7, 8–9, 10–14, and 15–19 was considered as normal, mild, moderate, and severe, respectively. The stress components scores were 0–14, 15–18, 19–25, and 26–33 as normal, mild, moderate, and severe stress, respectively. Permission to use the Hindi version of the scale was obtained, and the Cronbach's alpha values for the Hindi version of depression, anxiety, and stress domains were 0.998, 0.990, and 0.994, respectively.
A uniform general advice was given to all participants in the control group: “From your responses, I understand the health and emotional concerns after you have diagnosed with cancer. The regular adherence to the current treatment plan is essential for a better outcome. We will meet after 1 month to see your progress.” It was also delivered by the same brief psychological intervention nurse. Follow-up was scheduled after 1 month with each participant.
The nurse-led brief psychological intervention is a structured educational intervention containing one individual session of short duration (30 min) offered to help a person suffering from cancer to improve the QoL and to reduce the psychological distress. Personalized feedback was given to the participants based on their baseline assessment to commence the brief psychoeducation in a nonconfrontational way. The brief psychological intervention nurse would initiate an open-ended dialog with the subject by asking about their views and feelings related to the diagnosis and treatment. During this phase, the major goal of the assessment was to gain an understanding of the common perceptions of the illness in various aspects such as knowledge about disease status (past, present, and future) and irrational beliefs. The subjects were encouraged to express their own physical and psychological problems associated with the current treatment followed by prompt feedback as per the standard module. The nurse-led brief psychological intervention followed a structured standard protocol developed for the self-care management of side effects to the available treatment for breast cancer and head and neck cancer. The intervention included information about the common symptoms and related management to both types of cancers such as fatigue and tiredness, altered taste and smell conditions, sore mouth, hair loss, gastrointestinal disturbances such as nausea, vomiting, diarrhea, constipation, and the need for special care during conditions such as infection, anemia, and bleeding states. Further, the brief psychological intervention nurse, in liaison with the participant, would set action plans by illustrating simple cognitive strategies to encounter the unrealistic perceptions related to body image and self-concept. The Roy adaptation model was used as a theoretical model for the index study, and the content validity of the module was established through expert validation. Total 8 experts from psychiatry, clinical psychology, psychiatric nursing, and oncology were involved in the content validity of the module. Based on the expert's opinion, the overall quality and relevance of the module were evaluated in which the content validity index was 0.75. The brief psychological intervention nurse had undergone a 2-week induction and experiential training by a physician specialized in oncology who provided supervision, monitoring, and feedback throughout the study.
Data were analyzed using Statistical Package for Social Sciences (SPSS for Windows, Version 16.0. Chicago, SPSS Inc.). The comparisons of baseline sociodemography and clinical variables were done by Pearson's Chi-square test/Fisher's exact test/independent sample t-test. The general linear model (GLM) was used to examine the main effect of time and group × time interaction.
| Results|| |
The sample consisted of 80 cancer patients, with 40 each being present in the head and neck and breast cancer category. There were 20 subjects in the intervention and control group of each type of cancer category. The period of data collection was from January 1, 2020, to February 8, 2020. The mean age of the total subjects was 52.68 (standard deviation = 10), and most of the head and neck subjects were male (n = 36; 45%). The mean age was significantly more in the head and neck group than breast cancer, 56 versus 48 (P < 0.01). A major proportion of the breast cancer subjects were homemaker (35/40; 87.5%) and married (33/40; 82.5%). Except for age and occupation, the demographics of the study subjects were comparable at baseline [Table 1]. The study groups did not differ as per the total and subdomains of FACT-G scores at baseline (total FACT-G-F = 0.385; P = 0.764). The DASS-21 scores were also comparable at baseline (total DASS-21-F = 0. 2.253; P = 0.089). No statistically significant difference was observed in outcome measures during baseline [Table 2].
|Table 2: Comparison of outcome measures by the group as per preintervention scores|
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Effect of intervention
Pre- and post-test variations in the FACT-G and DASS-21 scores over time were examined using GLM with repeated measures. As per the repeated measure GLM, the time had a significant effect on the FACT-G score (F = 53.845; P = 0.000). The change in the FACT-G score remained significant even in the group × time interaction (F = 123.567; P < 0.000). The mean QOL was significantly improved in the physical, social, emotional, and functional domains of QOL at 1-month follow-up over time (total FACT-G, F = 123.567 and P < 0.01; physical domain, F = 63.003 and P < 0.01; social domain, F = 86.216 and P < 0.01; emotional domain, F = 81.862 and P < 0.01; and functional domain, F = 50.391 and P < 0.01). The self-reported psychological distress as per DASS-21 was significantly reduced in the intervention group as compared to control group over time (total DASS-21, F = 35.195 and P < 0.01; depression, F = 35.534 and P < 0.01; anxiety, F = 18.109 and P < 0.01; and stress F = 25.542 and P < 0.01). In summary, we observed a significant improvement in the QoL and reduction in the psychological distress in the intervention group as compared to the control group over time [Table 3].
|Table 3: Changes in outcome measures over time using general linear model with repeated measures|
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| Discussion|| |
The index study provides supporting evidence on the effectiveness of a nurse-led brief psychological intervention among treatment-seeking clients with head and neck and breast cancer. All the study subjects completed follow-up, which was done after 30 days (±7 days) of the baseline assessment. The self-administered Hindi version of FACT-G and DASS-21 was used for initial assessment as well as for follow-up. The major findings of the study are that individual-based, nurse-conducted brief psychological intervention can result in the improvement of QoL and reduction of psychological distress in the short-term (i.e., after 1 month of intervention). A meta-analysis by Cheng et al. compared the QoL outcome between nurse-led and nonnurse-led interventions for patients with cancer. The researchers identified that nurse-led disease management strategy seemed to be significantly effective to improve constipation, insomnia, and financial impacts for patients with cancer in QoL assessment. Compared to the findings of this meta-analysis, the present study observed a short-term improvement in the various domains of QoL in this setting.
The researchers evaluated the short-term effectiveness of a single session-based brief psychological intervention focused on coping with the physical and psychological along with the illustration of simple cognitive strategies to the elicited problems. Earlier studies evaluated the effectiveness on a long-term basis (i.e., from 6 months to 1 year). A study by Rodin et al. compared the brief, manualized psychotherapeutic intervention-managing cancer and living meaningfully (CALM) with usual care (UC) to treat and prevent depression and end-of-life distress in patients with advanced cancer. During a 3–6-month follow-up, CALM participants reported less-severe depressive symptoms than UC participants. However, a 1-year follow-up study identified that a brief psychological intervention may help prevent the occurrence of an anxiety or depressive disorder among newly diagnosed cancer patients. This suggests that similar interventions could help the patients to resolve the uncertainty about cancer treatment that might reduce the intensity of their anxiety and depression.
The index study identified that nurse-led psychological intervention programs might reduce psychological distress and improve the QoL in breast cancer patients. A previous study on breast cancer patients reported that a nurse-conducted psychological intervention program was effective in managing mood disturbance, anxiety, and depression and improving global health status and physical, role, and emotional functions. Another study evaluated the impacts of nurse-led telephone-based support on supportive care needs in women with breast cancer. The researcher offered teleservices regarding explanations about cancer treatments, side effects, and related management of treatment and self-care in cancer in areas of nutrition, physical activity, and sleeping. During 1-month follow-up, they reported a significant improvement in the supportive care practices in the intervention group as compared to the control group. The study observed a significant improvement in the outcome measures of breast cancer patients during the 1-month follow-up. Contrary to the current study findings, one study did not find any significant effect of a nurse-led care program for improving the QoL and self-efficacy among breast cancer patients. In their outpatient-based RCT, the researcher did not find any significant difference between the intervention arm and the control arm in the scores of QOL and self-efficacy over time. However, the investigators of the present study observed a significant improvement in the overall and separate domains of QoL (P < 0.001) and reduction of psychological distress (P < 0.01) in the intervention group as compared to control group during the 1-month follow-up.
The short-term effect of the nurse-led brief psychological intervention was observed in head and neck cancer patients in this setting. Similar findings were also reported in the research conducted on the head and neck cancer population. One systematic review reported a positive effect of nurse-led psychoeducational interventions in improving the QoL, treatment adherence, and reducing depressive symptoms in patients with head and neck cancer. Furthermore, in an RCT, the researcher also reported long-term effectiveness of a nurse-led psychosocial intervention on the depressive and physical symptoms of patients with head and neck cancer. During the 1 year of follow–up, they observed decreased levels of depressive symptoms in the intervention group with significant improvements in physical and emotional functioning. Moreover, one study reported that nurse-led follow-up care was significant in improving the QoL of head and neck cancer subjects as compared to conventional medical follow-up. Together with the earlier findings, the results of the present study suggest that nurse-conducted brief psychological intervention has a significant role in improving the QoL of head and neck cancer patients.
The findings should be interpreted with consideration of the limitations of this study. The results of the outcome measure are based on self-reported measures. The short-term outcome of a single session and long-term effect of the psychological intervention was not assessed due to the COVID-19-related lockdown in India. The study participants may not be representative as per gender as male gender was predominant in the head and neck cancer patients. Furthermore, the duration of intervention was 30 min and the control group received a one-minute routine advice. This gross discrepancy might have biased the results. Despite these limitations, this is the first randomized control trial from India to evaluate the effectiveness of a nurse-led brief psychological intervention in the oncological treatment setting.
| Conclusion|| |
The nurse-led brief psychological intervention may be an effective strategy for improving the QoL and reducing the psychological distress in treatment-seeking cancer individuals in this setting. Considering the short-term effect of this clinical intervention trial, more studies should be conducted in similar settings for an evidence base to advocate supportive nursing care practices in the routine oncology clinical setting.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]