Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800419
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2021-03-10
Brief Title:
RCT of Acceptance and Commitment Therapy Versus Mindfulness-based Stress Reduction in Head and Neck Cancer
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 societys 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
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 societys 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 3192 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 023 an alpha of 005 two-tailed The results indicated that the total sample of 63 for three equal-sized groups is needed to achieve a power of 095 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 111 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 patients appointment date for chemotherapy treatment
Therapists
The trainee therapists are two post-graduate students who enrolled in their Doctor of Philosophy PhD 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 005 and two-tailed
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 3192 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 023 an alpha of 005 two-tailed The results indicated that the total sample of 63 for three equal-sized groups is needed to achieve a power of 095 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 111 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 patients appointment date for chemotherapy treatment
Therapists
The trainee therapists are two post-graduate students who enrolled in their Doctor of Philosophy PhD 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 005 and two-tailed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None