RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer
- Conditions
- Cancer of Head and Neck
- Registration Number
- NCT04800419
- Lead Sponsor
- Universiti Sains Malaysia
- Brief Summary
Head and neck cancer is a group of biologically similar cancers which cause deleterious impact, such as the complication of facial disfigurement which may increase the psychological vulnerability of patients due to the society's emphasis on physical attractiveness. The appearance of facial disfigurement can increase depression and reduced quality of life (QoL) in head and neck cancer patients. Among the positive psychology developed in cancer patients despite their negative experience of cancer and the adverse effects of its treatment are posttraumatic growth (PTG) and hope which may enhance the QoL of cancer patients. Several psychosocial interventions have been suggested to enhance positive psychology in cancer patients and increase in their QoL. Data is lacking on the efficacy of mindfulness-based stress reduction (MBSR) on enhancing positive psychology (such as PTG, optimism and hope) and QoL among head and neck cancer patients. This is a multicentre, 2-armed longitudinal double blind randomized control trial aimed to test the study hypotheses of:
1. Head and neck cancer patients in the mindfulness-based stress reduction (MBSR) group reported significantly increase in posttraumatic growth (PTG), hope, optimism, and quality of life compared with those in the control group at post-intervention and 12 weeks after completion of intervention when compared with pre-intervention.
2. PTG, hope and optimism exerts partial mediation effects on the relationship between MBSR and quality of life among head and neck cancer patients.
- Detailed Description
As head and neck cancer differ from other types of cancer due to the complication of facial disfigurement which may increase the psychological vulnerability of patients due to the society's emphasis on physical attractiveness. Moreover, a number of devastating complications of the cancer itself and the side effects of its treatment such as fatigue, pain, problem with speech and swallowing, breathing problem, mucositis, xerostomia, and trismus which further exerts detrimental effects on many functions and activities of daily living which causes further psychological distress and decreasing quality of life. Hence, it is of utmost importance to investigate on psychosocial interventions which could enhance PTG, hope, optimism and QoL of head and neck cancer patients which in turn bring about the ultimate outcome of restoring mental and physical well-being of the cancer survivors. Mindfulness-based stress reduction (MBSR) have been reported to enhance positive psychology in cancer patients. But the effect of MBSR on PTG, hope, optimism, and QoL among head and neck cancer patients have not been studied. Hence, there is a need to conduct a 2-armed randomized control trial to evaluate the effects of MBSR on PTG, hope, optimism, and QoL compared with control group with treatment-as-usual (TAU) across time.
Below are the objectives of this study:
General objective:
To examine the effects of mindfulness-based stress reduction (MBSR) on posttraumatic growth (PTG), hope, optimism, and quality of life among head and neck cancer patients.
Specific objectives:
1. To examine the changes in the degree of posttraumatic growth (PTG), hope, optimism, and quality of life of head and neck cancer patients in the MBSR group compared with those in the TAU control group at post-intervention and 12 weeks after intervention compared with pre-intervention.
2. To evaluate the mediation effects of PTG, hope and optimism on the relationship between MBSR and quality of life among head and neck cancer patients.
Study Setting:
The study will be conducted the Oncology and Otorhinolaryngology unit of Advanced Medical and Dental Institute, Universiti Sains Malaysia and Oncology and Otorhinolaryngology unit of Universiti Kebangsaan Malaysia Medical Centre. The Oncological and Otorhinolaryngology units of AMDI, USM have about 200-250 registered head and neck cancer patients currently under follow up. These units receive new cases of head and neck cancer every week. While the Department of Otorhinolaryngology and Department of Oncology of UKMMC have an estimated 350-400 registered head and neck cancer patients while the Department of Oral and Maxillofacial Surgery of UKMMC has an estimated 100-150 registered oral cancer patients under follow up (oral cancer is grouped under head and neck cancer).
Study design:
This is a multicentre, 2-armed longitudinal double blind randomized control trial which is expected to run for a duration of 2 years.
Sample size:
The sample size is determined based on G-Power 3.1.9.2 for repeated measures, between-within interaction ANOVA. Based on the previous study Lengacher et al (2009), the sample size was calculated based on the medium effect size (0.41), an alpha of 0.05, study power of 0.8 and it is two-tailed. In anticipation of a drop-out rate of 20%, the estimation for sample size is 110 respondents for total respondents and 55 respondents for each group.
Sampling method:
Sampling method use in this study is by consecutive sampling.
Recruitment of subjects:
The participants were recruited from the source population which included all newly diagnosed head and neck cancer patients who has been treated only with surgery or still remain untreated registered under the Oncology and Otorhinolaryngology unit of Advanced Medical and Dental Institute, Universiti Sains Malaysia and Oncology and Otorhinolaryngology unit of Universiti Kebangsaan Malaysia Medical Centre. These patients will be approached by the research team and explained on the study objectives and procedures.
Randomization:
Participants will be randomized into two groups, such as mindfulness-based stress reduction (MBSR) group and TAU control group. The participants will be randomized into one of the three groups in a 1:1 allocation ratio by block randomization. The allocation sequence is concealed in a sealed, opaque, sequential numbered envelope.
Data collection:
Data collection is carried out by a research assistant who is not involved in conduct of the study and data analysis. In the pre-intervention phase (T1), the participants in the two groups are administered the following questionnaires:
(i) Socio-demographic and clinical questionnaire which includes age, gender, marital status, monthly income, stage of cancer and type of head and neck cancer.
(ii) The Posttraumatic Growth Inventory-Short Form (PTGI-SF) to assess the degree of PTG of the participants (iii) The Dispositional Hope Scale to assess the degree of hope of the participants (iv) The Life Orientation Test-Revised (LOT-R) to assess the degree of optimism (v) The Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) to assess the degree of quality of life
Then the assessments with the following questionnaires are repeated immediately post-intervention (T2) and 12 weeks after intervention (T3) among participants in all the two groups:
(i) The Posttraumatic Growth Inventory-Short Form (PTGI-SF) to assess the degree of PTG of the participants (ii) The Dispositional Hope Scale to assess the degree of hope of the participants (iii) The Life Orientation Test-Revised (LOT-R) to assess the degree of optimism (iv) The Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) to assess the degree of quality of life
Blinding:
The participants will be blinded for the study as randomization into designated groups are conducted by a research assistant not involved in the study and the allocation is concealed in opaque, sequential numbered envelope. Therefore, the participants will not know which group they are allocated to. Although participants in the MBSR group undergo psychosocial intervention earlier, the participants in the control group (who are assigned TAU) will also undergo non-therapeutic sessions with the same time and duration as that of the MBSR group.
The researchers will be blinded for the study as randomization of participants into designated groups are conducted by a research assistant not involved in the conducting the study and data analysis. Data collection will also be caried out by the research assistant who is not involved in conducting the study and data analysis and blinded regarding the hypotheses of the study. Moreover, the data analysis will be performed out by statisticians who are not involved in conducting the study and blinded regarding the hypotheses of the study.
Interventions:
The MBSR intervention will be conducted in a group of 10 for each session. The ACT and MBSR modules covered over 6 sessions, 2.5 hours in each session. The sessions will be held every week according to the patient's appointment date for chemotherapy treatment.
Therapists:
The trainee therapists are four post-graduate students who enrolled in their Doctor of Philosophy (Ph.D.) in psychology. They received training approximately 16 hours of MBSR intervention. In the MBSR training, the trainee therapists will learn the basic overview and concepts of MBSR including mindfulness, body scan and yoga. Besides, they also will experiential learning about formal and informal practices, recording and home practices.
Data analysis:
Data analysis will be performed using SPSS version 26 software. Descriptive statistics will be used to analyze demographic data while inference analyses will be used to evaluate the significant difference between intervention and waitlist groups. In order to identify the efficacy of mindfulness-based stress reduction (MBSR) on the measured variables, several tests will be carried out. The comparison of mean differences pre-intervention (T1), post-treatment (T2) and 12 weeks after intervention (T3) will be examined to determine whether any changes in the measured variables (PTG, hope, optimism, QoL) in the MBSR and control groups across the three timelines by using mixed linear model. The effect sizes will be calculated to determine how substantially patients' perception towards measured variables changed with and without MBSR interventions. Statistical significance is set at p \< 0.05 and two-tailed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in quality of life of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention pre-intervention, 6 weeks- immediately after completion of intervention, and 12 weeks after completion of intervention Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) is a self-reported tool which measures quality of life in patients with head and neck cancer. FACT-HN consists of 39 items and consists of 5 subscales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items) and head \& neck cancer additional concerns (12 items). Each item is scored in a 5-point Likert scale ranging from 0= Not at all to 4= Very much. The higher the score, the greater is the degree of QoL. The tool also registered excellent psychometric properties. The FACT-H \& N has been translated and validated in the Malaysian cancer population. All the subscales have moderate to good internal consistency with Cronbach's α ranging from 0.65 to 0.87. In this study, it is used to assess level of QoL among the participants.
- Secondary Outcome Measures
Name Time Method Change in level of hope of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention pre-intervention, 6 weeks- immediately after completion of intervention, and 12 weeks after completion of intervention Dispositional Hope Scale is a self-rated 12 items scale which assesses the responder's level of hope. It comprised of 2 subscales which incorporates Snyder's cognitive model of hope i.e. (a) Agency (goal-directed energy) and (b) Pathways (planning to accomplish goals). 4 of the 12 items assess agency while another 4 items assess pathways. The other 4 items are fillers. Each item is scored using Likert-point scale from Definitely False to Definitely True. The Malay version of Hope Scale demonstrated Cronbach's alpha of 0.716. Intraclass correlation coefficient (ICC) gave a good score of 0.67 (95% CI: 0.57-0.75). Confirmatory factor analysis demonstrated 2 factors in which there are 4 items for each factor as in the original version of Hope Scale. In this study, it is used to assess level of hope among the participants.
Change in optimism of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention pre-intervention, 6 weeks- immediately after completion of intervention, and 12 weeks after completion of intervention The Life Orientation Test-Revised (LOT-R) has 6 coded items with 3 framed in each direction, which are optimism and pessimism. The revision omitted or rewrote items that did not focus on explicit expectations. It has good internal consistency and stable over time. The positive and negative subsets are more strongly related to each other than those in the original Life Orientation Test. The Malay version of LOT-R demonstrated intraclass correlation coefficient (ICC) gave a good score of 0.62 (95% CI: 0.50-0.71). Confirmatory factor analysis demonstrated 2 factors in which there are 3 items for each factor as in the original version of LOT-R with factor loading ranging from 0.46 to 0.72. In this study, it is used to assess the level of optimism of the participants.
Change in posttraumatic growth of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention pre-intervention, 6 weeks-immediately after completion of intervention, 12 weeks after completion of intervention Posttraumatic Growth Inventory-Short Form (PTGI-SF) is the shorter version of the original Posttraumatic Growth Inventory and consists of 10 items where each of the 5 factors in posttraumatic growth is measured by 2 items. The higher the PTGI-SF score, the higher the level of posttraumatic growth in the individual being assessed. PTGI could be substituted by PTGI-SF with little loss of information. The PTGI-SF Malay version has good internal consistency which demonstrated Cronbach's alpha of 0.887 with the Cronbach's alpha of the 5 factors ranging from 0.700 to 0.813. Intraclass correlation coefficient (ICC) gave a good score of 0.75 (95% CI: 0.67-0.81). Confirmatory factor analysis demonstrated 5 factors in which there are 2 items for each factor as in the original version of PTGI-SF. In this study, it is used to assess level of posttraumatic growth among the participants.
Trial Locations
- Locations (1)
Advanced Medical and Dental Institute, Universiti Sains Malaysia
🇲🇾Kepala Batas, Pulau Pinang, Malaysia
Advanced Medical and Dental Institute, Universiti Sains Malaysia🇲🇾Kepala Batas, Pulau Pinang, Malaysia