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Head and neck cancer patients are vulnerable to various psychological complications due to the effects of both cancer itself and cancer treatment on patients' appearance and physical well-being. Nevertheless, few data have been obtained on effective psychosocial interventions that could protect this group of cancer patients' psychological well-being. Therefore, this two-armed, parallel-group, double-blind, randomized control trial (RCT) aims to evaluate and compare the effects of mindfulness-based stress reduction (MBSR) on psychosocial complications (depression, anxiety, and internalized stigma) among newly diagnosed head and neck cancer patients. This RCT will target newly diagnosed head and neck cancer patients who have been treated only with surgery or who have not yet received any treatment. In total, 106 patients who meet all of the study's inclusion criteria and none of its exclusion criteria will be randomly assigned into two groups-an MBSR group and a treatment-as-usual control group-at a 1:1' allocation ratio. Participants in the intervention group (MBSR group) will undergo an eight-week group intervention program. During this program, each intervention will comprise eight modules based on MBSR manual. Outcome assessments will be performed across a three-point timeline, including before the intervention (T0), immediately after the psychosocial intervention at eight weeks (T1), and 12 weeks after the intervention (T2). The primary outcome that will be assessed during this RCT is the severity of depression and anxiety. Meanwhile, the secondary outcome that will be evaluated in this study is such as internalized stigma.
Full description
Head and neck cancer differs from other cancer types due to various psychosocial issues associated with it. Moreover, the devastating complications of both cancer itself and cancer treatments' side effects-such as fatigue, pain, speech and swallowing problems, breathing problems, mucositis, xerostomia, and trismus-further disrupt many functions and daily living activities, increasing psychological distress and decreasing QoL [32, 33]. Therefore, an investigation of the psychosocial interventions that could enhance PTG, hope, optimism, and QoL among head and neck cancer patients is crucial. Reducing these patients' internalized stigma and EA could also ultimately restore these cancer survivors' mental and physical well-being. ACT and MBSR have been reported to enhance positive psychology and alleviate psychological distress among cancer patients [38, 49]. However, data regarding ACT and MBSR's effects on positive psychology, psychological sequelae and QoL in head and neck cancer patients are lacking. ACT's effects on PTG, hope, optimism, QoL, depression, anxiety, and EA among head and neck cancer patients have not been studied. Although MBSR has been reported to lower psychological distress and enhance QoL in head and neck cancer patients, its effects on positive psychology and EA have not been investigated. Hence, MBSR may act as a good comparator intervention to ACT for evaluating its efficacy on positive psychology, psychological sequelae and QoL among head and neck cancer patients. Therefore, we have proposed a three-armed RCT to evaluate these effects over time compared to a control group receiving treatment-as-usual.
Objectives:
Primary objectives:
Evaluate MBSR's efficacy in alleviating the severity of depression and anxiety among head and neck cancer patients compared to a control (treatment-as-usual) immediately after the eight-week intervention and 12 weeks post-intervention compared to pre-intervention.
Secondary objective:
Examine MBSR's efficacy in alleviating internalized stigma among head and neck cancer patients compared to a control (treatment-as-usual) immediately after the eight-week intervention and 12 weeks post-intervention compared to pre-intervention.
Methods/design:
Design:
The current study will conduct a multicentre, two-armed, parallel-group, double-blind RCT that conducted over one and a half year.
Setting This study will be conducted in Advanced Medical and Dental Institute (AMDI) at the Universiti Sains Malaysia (USM) and Universiti Kebangsaan Malaysia Medical Centre (UKMMC). AMDI, USM is a tertiary referral center for oncology in Peninsular Malaysia while UKMMC is a tertiary referral center for various illnesses, including oncology cases in Peninsular Malaysia.
Support and ethics This study has received approval from the Human Research Ethics Committee of Universiti Sains Malaysia (code: USM/JEPeM/21040336). The study will be conducted in compliance with the Declaration of Helsinki (1974) and its amendments, as well as the Malaysian Good Clinical Practice Guidelines for Clinical Trials. The institutional review board will be informed of any modification to the study's protocol (such as its eligibility criteria, study procedures, outcome measures, scheduled interventions, and data analyses) in writing. This manuscript was written without any deviation from the original protocol submitted to the Human Research Ethics Committee of Universiti Sains Malaysia.
The principal investigator will lead the trial center and closely coordinate with the research coordinator and the site coordinator, participate in subject recruitment, and oversee the study's consent procedures. A trial monitoring committee has been established. This committee is chaired by the principal investigator, and it will meet weekly to manage the study on a day-to-day basis, audit trial conduct, and prepare reports for submission to the Human Research Ethics Committee of Universiti Sains Malaysia. The trial's data monitoring and auditing will be conducted by the AMDI's clinical trial coordination unit at the Universiti Sains Malaysia-independently from the trial's funder.
All participants will be permitted to withdraw from the study at any time without specifying the reason for their withdrawal, and we will not use any of the information collected from participants who choose to withdraw. Prior to their participation in this study, participants will be informed that the results of this study will only be used for research purposes and will not be recorded in patients' case files. Participants' personally identifiable information will not be sought or recorded, and participants' anonymity will be assured. Each participant will be sequentially assigned a research number (e.g., RCT001, RCT002, etc.). All documents involved in this study's assessment of research subjects-including participants' personal information (socio-demographic, substance history, symptomatology, and questionnaire responses)-will be stored in document files and locked in a cabinet whose key is kept by the corresponding author.
Participants may also withdraw from the study if an adverse event occurs. An adverse event (AE) is any untoward medical occurrence involving a participant in a trial intervention that does not necessarily causally relate to this treatment. An AE can be any unfavorable or unintended sign, symptom, or disease that is temporarily associated with the use of an investigational intervention, whether related or unrelated to the investigational intervention. Participants will be issued a study card featuring the research team's contact details and encouraged to maintain close contact by phone and report any AE. If an AE occurs, the event will be reported in the "Adverse Event" section of the study's case report form (CRF), and a serious adverse event report will be filled out if necessary. Such reports would include the AE's name, date of onset and date of recovery, severity, relationship to the studied intervention, measures undertaken regarding the studied intervention, treatment, and outcome (whether resolved or ongoing). All serious AEs will be reported to the Human Research Ethics Committee of Universiti Sains Malaysia. AE-related criteria that would exclude participants from the study are:
Only the study's corresponding author and co-authors are permitted to access the study's files for data analysis or publication purposes. The findings of this study will be submitted for publication in peer-reviewed academic journals and for presentation at international conferences and symposia. The study's principal investigator will be listed as the corresponding author, and authorship eligibility will be based on the International Committee of Medical Journal Editors' recommendations.
All of this study's investigators declare no financial or other competing interests in conducting this study.
Participants:
This study's participants will be recruited from the source population. This population includes all newly diagnosed head and neck cancer patients who have been treated only with surgery or who have not yet received treatment and who are registered under the oncology and otorhinolaryngology unit of the Advanced Medical and Dental Institute (AMDI) at the Universiti Sains Malaysia (USM) or the oncology and otorhinolaryngology unit of Universiti Kebangsaan Malaysia Medical Centre (UKMMC). The sample size was estimated using the sample size calculator developed by Lu et al. (2008) for mixed linear models. Key parameters included a standard mean difference of 0.65 (Lengacher et al., 2009), a type I error of 0.05, power of 0.8, a 1:1 group allocation ratio, three time points, and estimated attrition rates of 10% (from T0 to T1) and 20% (from T1 to T2). Based on these calculations, the estimated sample size was 53 participants per group.
Inclusion and exclusion criteria:
The inclusion criteria included: (1) those diagnosed with HNC confirmed by histopathological report and at any stage of cancer, (2) those aged 18 years old and above, (3) those who have completed surgery and started chemotherapy and/or radiotherapy and (4) literate in the Malay language. While the exclusion criteria were: (1) history of pre-existing psychiatric illnesses (such as psychotic disorder, bipolar disorder, anxiety disorder, depressive disorder, neurodevelopmental disorder, neurocognitive disorder), (2) history of pre-existing medical illnesses which may induce psychiatric symptoms (such as kidney and liver failure, ischemic heart disease, epilepsy, hyperthyroidism, hypothyroidism, Cushing's syndrome, Addison's disease, systemic lupus erythematosus, neurological disorder, rheumatoid arthritis), (3) history of illicit drug and alcohol use, (4) pregnancy, (5) suicidal tendency, (6) those with history of engaged in other psychotherapy, and (7) those who are not physically and cognitively fit to participate in the study.
Recruitment process:
This study will use a consecutive sampling method. The research team will approach head and neck cancer patients registered at the two targeted institutions and explain the study's objectives and procedures. Patients who are interested in participating in this study will be screened for inclusion and exclusion criteria by a research team member. All eligible patients will be invited to participate in this study. The study's purposes and procedures will be thoroughly explained (verbal explanation by the research assistant and a copy of the participant information will also be distributed) to prospective participants before they are invited to participate in this study, their anonymity will be assured, and they will be informed of their right to withdraw from the study at any time and the data collected will be discarded. Eligible patients will be given 48 hours to decide on their participation in the study. Then, participants will sign written informed consent to participate in the study before they enroll in the study.
Randomization:
This study will use stratified permuted block randomization, stratifying trial participants according to their age (18 to 40 years old, 41 to 60 years old, and over 60 years old) and gender (male and female). Participants will be randomized into two groups: an MBSR group and a control group of patients on treatment-as-usual for intervention. Using a 1:1 allocation ratio and block randomization, we will randomly assign participants to the two groups. An allocation sequence will be generated via computer-generated random numbers, which will be obtained by a research assistant who is not otherwise involved in this study. The allocation sequence will be concealed in an opaque, sequentially numbered envelope.
Interventions:
An eight-week psychosocial intervention will be administered to participants in the intervention group (MBSR) while participants in the control group will receive treatment-as-usual. The study's outcomes will be assessed at three times: pre-intervention (T0), immediately after the eight-week intervention (T1), and 12 weeks after the intervention (T2).
The MBSR intervention will comprise eight sessions delivered at a rate of one session per week. Each session will last for 2.5 hours. At AMDI, USM, and UKMMC, chemotherapy for head and neck cancer lasts for 8 weeks, delivered at a rate of one session per week. Similarly, radiotherapy for head and neck cancer lasts for eight weeks at these institutions. Therefore, this study's MBSR sessions will align with participants' chemotherapy or radiotherapy sessions to ensure that all participants attend their intervention sessions. MBSR will be provided in group settings with intervention groups of 10 participants each.
Mindfulness-based stress reduction (MBSR):
MBSR will be conducted as group sessions, with each session lasts for 2.5 hours, once a week for 8 weeks with another 45 minutes of home practice on daily basis. The MBSR sessions will be based on therapy format developed by Kabat-Zinn. All the sessions focus on mindfulness practices, sharing of experiences with others, and didactic teaching on stress. Mindfulness practices which will be discussed include body scan exercise, and mindful breathing meditation techniques, three-minute breathing exercises, five-minute seeing or hearing exercises, bodily mindfulness in movement and mindful stretching, yoga and sitting meditation. The therapists will review feedbacks for each session, acknowledge the thoughts, feelings, and senses, examine how participants practice mindfulness, and give assignments to encourage participants to continually practice mindfulness at home. Each participant will receive a CD detailing on meditation practices and a workbook on the mindfulness practices.
Treatment-as-usual control group:
The participants in the control group will receive treatment-as-usual in which routine oncology support such as appointment with oncologists or palliative care physicians, general practitioner for usual cancer care. The participants physical health and medications for their cancer treatment will be reviewed and treatment will be modified according to physical symptoms such as pain. Specific psychological interventions such as cognitive behavioral therapy, interpersonal therapy, mindfulness-based interventions, acceptance and commitment therapy, etc will be avoided.
Treatment fidelity:
MBSR will be conducted for the MBSR group by a therapist trained in MBSR, and a trained backup therapist will be on standby to replace the primary therapist when necessary. All the study's therapists and backup therapists will be postgraduate students in psychology who are not otherwise involved in the study. All the therapists have two-year experience of conducting psychotherapy. They will also receive training manual detailing the psychotherapy sessions for MBSR, and they will also undergo 2 full days of brief training workshop for MBSR from the experienced psychiatrists and clinical psychologists not involved in the study. As for monitoring of treatment integrity, a psychiatrist and a clinical psychologist, both trained in MBSR will measure the delivery of the interventions by all the therapists in the ACT and MBSR groups independently. 15% of audio-recording of the psychotherapy sessions will be randomly selected and stratified according to therapist and the phase of intervention (early, middle or end) and then, treatment integrity assessments will be performed by using: the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC). Each treatment integrity assessor will assess half of the selected sessions. Finally, the interrater reliability of the two treatment integrity assessors is computed to assess the treatment integrity of all the therapists in delivering the interventions. In addition, experienced psychiatrists and clinical psychologists not involved in the study will discuss issues regarding the delivery of the interventions with the therapist who is inconsistent in conducting the MBSR sessions.
Blinding:
The researchers will also be "blinded" for the study since the participants' randomized assignment into the designated groups will be conducted by a research assistant who is not otherwise involved in the study or data analysis. This project's data collection will also be conducted by that research assistant who is not otherwise involved in the study or data analysis and who is unaware of the study's hypotheses. Moreover, the project's data analysis will be conducted by statisticians who are not otherwise involved in the study. A statistical analysis plan is established prior to the final unblinded of the data lock.
Measures:
Data collection will be conducted every weekday during working hours, and flyers announcing the study and the benefits of participating in this study will be disseminated to all newly diagnosed head and neck cancer patients at the study's focal institutions (within one month of their diagnosis) in order to ensure adequate subject enrolment to achieve the calculated sample size. This clinical trial protocol was written according to the CONSORT 2025 Statement: updated guideline for reporting randomised trials.
Sociodemographic and tumor characteristics:
The sociodemographic characteristics which will be recorded from each participant include age, gender, ethnicity, marital status, education, and employment status. While the tumor characteristics which will be gathered from the participants are duration of cancer diagnosis, types of head and neck cancer, stage of cancer and modalities of cancer treatment received.
Primary outcomes:
Depression and anxiety: The Malay version of the "Hospital Anxiety and Depression Scale" (HADS) will be used to assess the severity of depression and anxiety symptoms among participants.
Secondary outcome:
Internalized stigma: The Malay version of the "Shame and Stigma Scale" (SSS) will be used to measure the degree of internalized stigma among participants.
Other measures:
The participants compliance to the interventions will be recorded as they will be requested to fill in electronic dairies regarding their performance of the home assignments and practice of the interventions at home. The reasons for absence from therapy sessions, dropouts and loss to follow up (such as loss of interest to participate, dislike of the intervention, not feeling well or death) will also be recorded.
Data analysis:
All of this study's data analysis will be conducted using the Statistical Package for Social Sciences, version 26 (SPSS 26; SPSS Inc., Chicago, Illinois, USA). Initially, the baseline sociodemographic and tumor characteristics will be presented by randomized groups (MBSR and control groups).
The mean difference in the primary outcome (HADS score) for the two randomized groups (MBSR and control groups) at each specific time point (pre-intervention [t0], post-treatment at 8 weeks [t1] and 12 weeks after intervention [t2]) will be assessed using mixed linear model will be employed for comparing the primary outcomes (HADS- Depression and Anxiety Subscores) between between MBSR and control groups across the three time points (t0, t1 and t2), while controlling for stratification factors such as age and gender. The main effects of intervention in the groups and time points will be presented as standardized mean difference. The study's primary analysis will follow the intention-to-treat (ITT) principle. The data analysis for the study's secondary outcome (total SSS score) will be conducted similarly to the primary outcomes' calculation. In addition, 95% confidence interval will also be presented alongside the main effect. Statistical significance will be two-tailed and set to p < 0.05.
To handle any missing data, if the missing data represent less than 5% of the study's total collected data, they will be ignored. If the missing data represent more than 5% but less than 40% of the total collected and are assumed to be randomly missing, then multiple imputation (restricted maximum likelihood estimation) will be performed using Stata 15. However, if the missing data represent more than 40% of the total collected data or are assumed to be missing either not randomly or completely randomly, then only the collected data will be used for the study's analysis, and the missing data will be explained as a research limitation in any publications of the study's findings.
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Inclusion criteria
(1) those diagnosed with HNC confirmed by histopathological report and at any stage of cancer, (2) those aged 18 years old and above, (3) those who have completed surgery and started chemotherapy and/or radiotherapy and (4) literate in the Malay language.
Exclusion criteria
(1) history of pre-existing psychiatric illnesses (such as psychotic disorder, bipolar disorder, anxiety disorder, depressive disorder, neurodevelopmental disorder, neurocognitive disorder), (2) history of pre-existing medical illnesses which may induce psychiatric symptoms (such as kidney and liver failure, ischemic heart disease, epilepsy, hyperthyroidism, hypothyroidism, Cushing's syndrome, Addison's disease, systemic lupus erythematosus, neurological disorder, rheumatoid arthritis), (3) history of illicit drug and alcohol use, (4) pregnancy, (5) suicidal tendency, (6) those with history of engaged in other psychotherapy, and (7) those who are not physically and cognitively fit to participate in the study
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110 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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