Clinical trial NCT04800419: RCT of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: Acceptance and Commitment Therapy
Mindfulness
Posttraumatic Growth
Hope
Optimism
Quality of Life
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Xinxiang medical university
First posted: 2021-03-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in posttraumatic growth at 8 weeks and 6 months after completion of intervention
timeFrame: pre-intervention, 8 weeks, and 6 months after completion of intervention
measure: Change in quality of life of head and neck cancer patients at 8 weeks and 6 months after completion of intervention
timeFrame: pre-intervention, 8 weeks, and 6 months after completion of intervention
measure: Change in experiential avoidance at 8 weeks and 6 months after completion of intervention
timeFrame: pre-intervention, 8 weeks, and 6 months after completion of intervention
measure: Change in severity of depressive and anxiety symptoms at 8 weeks and 6 months after completion of intervention
timeFrame: pre-intervention, 8 weeks, and 6 months after completion of intervention
Secondary outcomes:
measure: Change in dispositional hope at 8 weeks and 6 months after completion of intervention
timeFrame: pre-intervention, 8 weeks, and 6 months after completion of intervention
measure: Change in optimism at 8 weeks and 6 months after completion of intervention
timeFrame: pre-intervention, 8 weeks, and 6 months after completion of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Advanced Medical and Dental Institute, Universiti Sains Malaysia
name: Mohammad Farris Iman Leong Bin Abdullah, Dr Psych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Z, Leong Bin Abdullah MFI, Shari NI, Lu P. Acceptance and commitment therapy versus mindfulness-based stress reduction for newly diagnosed head and neck cancer patients: A randomized controlled trial assessing efficacy for positive psychology, depression, anxiety, and quality of life. PLoS One. 2022 May 10;17(5):e0267887. doi: 10.1371/journal.pone.0267887. eCollection 2022.