RCT of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Head and Neck Cancer

Cancer of Head and Neck Clinical Trial

Official title:

Randomized Controlled Trial of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Newly Diagnosed Head and Neck Cancer: Assessing Their Effect on Positive Psychology, Depression, Anxiety, and Quality of Life

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04800419
• Other study ID #: MFLeong
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2021
• Source: Universiti Sains Malaysia
• Contact: Mohammad Farris Iman Leong Bin Abdullah, Dr Psych
• Phone: +604-5622482
• Email: farris[@]usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Among the psychosocial interventions shown to be promising include mindfulness-based intervention and newer psychosocial intervention, such as acceptance and commitment therapy (ACT). Data is lacking on the efficacy of mindfulness-based stress reduction (MBSR) and acceptance and commitment therapy (ACT) on enhancing positive psychology (such as PTG, optimism and hope) and QoL, while reducing depression and anxiety among head and neck cancer patients. This is a multicentre 3-armed longitudinal double blind randomized control trial aimed to test the study hypotheses of:

1. Head and neck cancer patients in the acceptance and commitment therapy (ACT) group reported significantly increase in posttraumatic growth (PTG), hope, optimism, and quality of life as well as significantly reduced depression, anxiety, and experiential avoidance compared with those in the control group at post-intervention and 6 months after intervention when compared with pre-intervention.

2. 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 as well as significantly reduced depression, anxiety, and experiential avoidance compared with those in the control group at post-intervention and 6 months after intervention when compared with pre-intervention.

3. There are no difference in the increase in posttraumatic growth (PTG), hope, optimism and quality of life, and decrease in depression, anxiety, and experiential avoidance between the MBSR and ACT groups at post-intervention and 6 months after intervention.

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 as well as reducing internalized stigma and experiential avoidance 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. Acceptance and commitment therapy (ACT) and mindfulness-based stress reduction (MBSR) have been reported to enhance positive psychology and alleviate psychological distress in cancer patients. But the effect of ACT and MBSR on PTG, hope, optimism, QoL, depression, anxiety and experiential avoidance among head and neck cancer patients have not been studied. Hence, there is a need to conduct a 3-armed randomized control trial to evaluate the effects of ACT and MBSR on PTG, hope, optimism, QoL, internalized stigma and experiential avoidance compared with control group with no intervention across time.

Below are the objectives of this study:

General objective:

To examine the effects of acceptance and commitment therapy (ACT) and mindfulness-based stress reduction (MBSR) on posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance among head and neck cancer patients.

Specific objectives:

1. To examine the changes in the degree of posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance of head and neck cancer patients in the acceptance and commitment therapy (ACT) group compared with those in the control group at post-intervention, 6 months and 12 months after intervention compared with pre-intervention.

2. To examine the changes in the degree of posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance of head and neck cancer patients in the mindfulness-based stress reduction (MBSR) group compared with those in the control group at post-intervention, 6 months and 12 months after intervention compared with pre-intervention.

3. To determine whether there are any difference in the changes in the degree of posttraumatic growth (PTG), hope, optimism, quality of life, depression, anxiety, and experiential avoidance between those in the acceptance and commitment therapy (ACT) group and mindfulness-based stress reduction (MBSR) group at post-intervention, 6 months and 12 months after intervention.

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 3-armed longitudinal double blind randomized control trial which is expected to run for a duration of 3 years (from July 2021 to June 2024).

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, the sample size was calculated based on the continuous response, Post-traumatic growth inventory from the study conducted by Labelle et al. (2014), with medium effect size (0.23), an alpha of 0.05, two-tailed. The results indicated that the total sample of 63 for three equal-sized groups is needed to achieve a power of 0.95. In anticipation of a drop-out rate of 30%, the estimation for sample size is 90 respondents for total respondents and 30 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 three groups, such as acceptance and commitment therapy (ACT) group, mindfulness-based stress reduction (MBSR) group and control group on waiting list. The participants will be randomized into one of the three groups in a 1:1:1 allocation ratio by block randomization. The allocation sequence is concealed in 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 all three groups are administered the following questionnaires:

(i) Socio-demographic and clinical questionnaire which includes age, gender, marital status, employment, education, monthly income, religion, 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 Hospital Anxiety and Depression Scale (HADS) to assess the severity of depressive and anxiety symptoms (v) The Life Orientation Test-Revised (LOT-R) to assess the degree of optimism (vi) The Acceptance and Action Questionnaire (AAQ-II) to assess the degree of experiential avoidance (vii) 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 6 months after intervention (T3) among participants in all the three 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 Hospital Anxiety and Depression Scale (HADS) to assess the severity of depressive and anxiety symptoms (iv) The Life Orientation Test-Revised (LOT-R) to assess the degree of optimism (v) The Acceptance and Action Questionnaire (AAQ-II) to assess the degree of experiential avoidance (vi) 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 ACT and MBSR groups undergo psychosocial intervention earlier, the participants in the control group (who are assigned in the waitlist) will also undergo ACT once they have completed assessments at three-time frames (T1, T2, and T3). All the participants will also be blinded regarding the hypotheses of the study.

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:

Both ACT and MBSR intervention will be conducted in a group of 10 for each session. The ACT and MBSR modules covered over 8 sessions, 1 hour 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 two post-graduate students who enrolled in their Doctor of Philosophy (Ph.D.) in psychology. They received training approximately 16 hours of ACT intervention and 16 hours of MBSR intervention. In ACT intervention training, trainee therapists will learn about general core concepts of ACT, principals, model, framework, and philosophy. Besides, they also will learn how to apply ACT therapy including engagement with each element in hexaflex, integrating exercises, metaphors, techniques, and mindfulness in ACT sessions and clinical practices. 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 acceptance and commitment therapy (ACT) and 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 6 months after intervention (T3) will be examined to determine whether any changes in the measured variables (PTG, hope, optimism, QoL, depression, anxiety, and experiential avoidance) in the ACT, MBSR and control groups across the three timelines by using repeated measure ANOVA. Then, the mean differences of measured variables (PTG, hope, optimism, QoL, depression, anxiety, and experiential avoidance) between ACT, MBSR and control groups at each timeline will be determined by using the one-way ANOVA. The effect sizes will be calculated to determine how substantially patients' perception towards measured variables changed with and without ACT and MBSR interventions. Statistical significance is set at p < 0.05 and two-tailed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Those who are newly diagnosed with head and neck cancer confirmed by histopathological examination report who have been treated only with surgery or still remain untreated, at any stage of cancer except for those with metastasis to the central nervous system.

• Age 18 years and above.

• Can understand English or Malay.

• Those who are post-surgery and plan for the standard regime of chemotherapy.

• Those who developed depression and anxiety symptoms after diagnosis with head and neck cancer with Hospital Anxiety and Depression Scale (HADS)- Depression subscale score of = 8 and HADS- Anxiety subscale score of = 8.

Exclusion criteria:

• Those with history of pre-existing psychiatric illnesses, such as depression, anxiety disorders, schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, bipolar mood disorder, posttraumatic stress disorder, obsessive compulsive disorder, and neurodevelopmental disorders (patients are screened with Mini International Neuropsychiatric Interview to exclude these disorders).

• Those with history of illicit drug intake and those with substance use disorder, alcohol use disorder, substance-related disorders and alcohol-related disorders (patients are screened with urine dipstick for drugs and Mini International Neuropsychiatric Interview to exclude these conditions).

• Those with history of medical illnesses which can induced psychiatric symptoms such as cancer, stroke, coronary heart disease, congestive cardiac failure, COPD, bronchial asthma, systemic lupus erythematosus, rheumatoid arthritis, renal failure, hepatic failure, endocrine disorders, multiple sclerosis, Parkinson's Disease, and epilepsy.

• Those who are currently on any psychotherapy or counselling sessions.

• Those who are physically unfit to perform intervention.

• Those who exhibit cognitive impairment (patients are screen with Mini Mental State Examination, in which those with score of < 24/30 will be excluded).

• Those who have not received any pharmacotherapy for their anxiety and depressive symptoms which developed after diagnosis of cancer.

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT)
ACT is a third generation cognitive behavioral approach which uses acceptance and mindfulness processes, and commitment and behavior change processes to produce psychological flexibility. ACT increase adaptive coping through acceptance, cognitive defusion, mindfulness, and perspective-taking exercises while supporting cancer survivors in aligning behavior with their personal values. The objectives of the therapy are for client to learn to focus on behaviors and actions that are in line with their individual values - the things they care about most. ACT facilitates development and maintenance of health behavioral improvements by targeting internal barriers, such as emotional discomfort and self-defeating thoughts, and by fostering connection and commitment to personal values associated with self-management of positive health behaviors. ACT is useful in cancer patients, because it can help them to deal with the negative emotions caused by cancer instead of avoiding these.
• Mindfulness-based Stress Reduction (MBSR)
The term 'mindfulness' refers to mindful awareness as a way of being - a knowing and experiencing of feelings, thoughts, and perceptions as they arise and pass away each moment. It is a way of relating to all experiences in an open, receptive way, without judging experiences as good or bad (grasping at them or pushing them away). Mindfulness employed two styles of meditations: concentrative meditation involves intentionally focusing attention on a chosen object (e.g. the sensations of breathing) in a sustained way, while receptive meditation involves monitoring the content of experience (e.g. sensations, emotions, thoughts, sounds, etc.) in a non-reactive and non-judgmental way, from moment to moment, with the goal being to recognize the nature of emotional and cognitive patterns. Mindfulness-based stress reduction (MBSR) is an 8-week, standardized group intervention consisting of mindfulness meditation and gentle yoga that is designed to have applications for stress, pain, and illness

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	Xinxiang medical university

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in posttraumatic growth at 8 weeks and 6 months 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.	pre-intervention, 8 weeks, and 6 months after completion of intervention
Primary	Change in quality of life of head and neck cancer patients at 8 weeks and 6 months 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 a ranging from 0.65 to 0.87. In this study, it is used to assess level of QoL among the participants.	pre-intervention, 8 weeks, and 6 months after completion of intervention
Primary	Change in experiential avoidance at 8 weeks and 6 months after completion of intervention	Acceptance and Action Questionnaire (AAQ-II) measured experiential avoidance or psychological inflexibility. AAQ II is the second version and revised from the original version which consists of a shorter version (7 items) with better psychometric consistency. The scores were calculated by summing up the seven items. Higher scores indicated higher levels of psychological inflexibility. Validation of the Malay version of the AAQ-II indicated that the tool had excellent internal consistency with Cronbach's a of 0.91 and was a unidimensional scale that measured psychological inflexibility/experiential avoidance. In this study, it is used to assess the degree experiential avoidance in the participants.	pre-intervention, 8 weeks, and 6 months after completion of intervention
Primary	Change in severity of depressive and anxiety symptoms at 8 weeks and 6 months after completion of intervention	The Hospital Anxiety and Depression Scale (HADS) is a self-rated questionnaire that assesses patients' severity of anxiety and depression using seven items designated for depression subscale and seven items for anxiety subscale. Each item scores from 0 to 3, and the range of total score for both depressive and anxiety subscales ranged from 0 to 21 per subscale. The cut-off for caseness of depression is 8/21 and the cut-off for caseness of anxiety is also 8/21. The anxiety subscale has a sensitivity of 0.9 and specificity of 0.78 and the depression subscale has a sensitivity of 0.83 and specificity of 0.79. The Malay version of HADS has been validated in Malaysian breast cancer patients and exhibited acceptable to good internal consistency for its total score and subscales with Cronbach's a ranging from 0.73 to 0.87.	pre-intervention, 8 weeks, and 6 months after completion of intervention
Secondary	Change in dispositional hope at 8 weeks and 6 months 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.	pre-intervention, 8 weeks, and 6 months after completion of intervention
Secondary	Change in optimism at 8 weeks and 6 months 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.	pre-intervention, 8 weeks, and 6 months after completion of intervention