Cancer BreastNCT07205965
The Effect of Acceptance and Commitment Approach-Based Psychoeducation in Cancer Survivors
A study testing Experimental Group in people with Cancer Breast and Colon Cancer, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial summary
The study is planned to be conducted in a randomised controlled experimental design in accordance with CONSORT. The study is planned to be conducted between September 2025 and December 2026 at X Hospital with individuals who have completed cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Breast, Colon Cancer, Cancer Survivors
- What is being tested?
- Experimental Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Nov 2025to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having completed cancer treatment, having completed treatment for breast, gynaecological, colon or rectal cancer, having internet access, and being at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale.
Who cannot join
- receiving another psychosocial intervention, using psychiatric medication other than antidepressants, being in an advanced stage of cancer, having metastatic cancer, having recurrent cancer, and having started antidepressants in the last three months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dokuz Eylul University
Izmir, 35340
Dokuz Eylul University
Izmir
About this study
Official title: The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Anxiety, Depressive Symptoms, Psychological Flexibility, Mindfulness and Valuing in Cancer Survivors: A Randomized Controlled Trials
The study is planned to be conducted in a randomised controlled experimental design in accordance with CONSORT. The study is planned to be conducted between September 2025 and December 2026 at X Hospital with individuals who have completed cancer treatment. The randomisation list will be concealed from the participants, and each participant will be informed of which group they have been assigned to after being included in the study. The 'Stratified Randomisation' method will be used to determine which group participants will be assigned to, and participants will be included in the study based on their scores on the HAD scale. They will then be divided into experimental and control groups. To prevent study bias, the assignment of intervention and control groups will be conducted by an expert who has not participated in the study, with the aim of keeping the randomisation information confidential. The experimental group will consist of a total of 16 participants and will receive individual psychoeducation in an internet-based environment for 6 weeks, with each session lasting 30 minutes. No intervention will be made to the control group during the application period, and they will be placed on a waiting list. Participants who complete the psychoeducation will undergo follow-up measurements via an internet-based platform one month, six months, and one year after the psychoeducation, and their scores will be compared with those of the control group. The sample criteria include: having completed cancer treatment, having completed treatment for breast, gynaecological, colon or rectal cancer, having internet access, and being at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale. Exclusion criteria include receiving another psychosocial intervention, using psychiatric medication other than antidepressants, being in an advanced stage of cancer, having metastatic cancer, having recurrent cancer, and having started antidepressants in the last three months. Participants will be asked to complete a demographic information form. In addition, anxiety and depression levels will be measured using the Hospital Anxiety and Depression (HAD) scale. Psychological flexibility will be measured using the Acceptance and Action Questionnaire-II, mindfulness will be measured using the Mindfull Attention Awareness Scale, and the level of valuing will be measured using the Valuing Questionnaire. Validity and reliability studies have been conducted for the scales. Ethical committee approval has been obtained. Institutional approval has been obtained from the hospital where the study is being conducted.
Read the detailed description
According to World Health Organisation data, approximately one in six deaths is due to cancer (WHO, 2022). With the development of healthcare services, cancer survival rates are increasing and progress is being made in the treatment of the disease, but the physical and psychosocial effects of cancer on individuals continue (Li, Guo, Li \& Yang, 2021). In recent years, new approaches have been developed to support the mental well-being of cancer patients. The foremost of these is Acceptance and Commitment Therapy (ACT). ACT is an approach developed as a result of the interaction between empirical data obtained from scientific research on human behaviour and clinical experience. ACT, which comes from a humanistic model, emphasises awareness and self-compassion. As a behavioural therapy, ACT draws its origins from the perspectives of Skinner and Pavlov and is based on the Relational Frame Theory, which focuses on the nature of human language and cognitive processes. ACT aims to increase functionality and enable individuals to live more meaningful and valuable lives by using mindfulness. ACT intervention consists of six important cognitive processes. These are a therapeutic approach model consisting of values, contact with the present moment, cognitive defusion, acceptance, contextual self, and committed action. The aim of this study is to examine the effect of acceptance and commitment therapy-based psychoeducation applied to cancer survivors on individuals' anxiety, depressive symptoms, psychological flexibility, acceptance, value-oriented life, and awareness.
The study consists of survivors diagnosed with one of the following types of cancer: breast, gynaecological, colon, or rectal. Participants will be invited to join the study via telephone from the oncology unit's database, targeting patients who have completed these treatments within the past 1-12 months. Accepting patients will first be interviewed in person, and the HAD scale will be administered. Participants who meet the eligibility criteria will be included in the study. Inclusion criteria: - Being between 18 and 65 years of age, having completed cancer treatment, being able to speak Turkish, and, according to the Hospital Anxiety and Depression (HAD) scale, having distress in one or both of the depression or anxiety subscales (HAD-A ≥ 10 and/or HAD-D ≥ 7 based on the cut-off score), and having internet access. The exclusion criteria for the study are receiving another psychosocial intervention, cancer metastasis or recurrence, use of psychiatric medication other than antidepressants, and initiation of antidepressant treatment in the last three months.
The aim of this study is to examine the effect of acceptance and commitment therapy-based psychoeducation applied to cancer survivors on individuals' anxiety, depressive symptoms, psychological flexibility, acceptance, value-oriented life, and awareness.
For the sample calculation required for the study, the G power statistical analysis programme was used, with a Type I error of 0.05, a Type II error of 0.20 (power 0.80), and an effect size of 0.25, and an ANOVA test was applied. Anticipating possible losses in the sample, a total of 32 participants, 16 in each group, are planned to be included. In the data analysis of the study, descriptive statistics will be expressed as numbers (n) and percentages (%) for discrete variables and as mean ± standard deviation (minimum-maximum) for continuous variables. In all analyses, p-values less than 0.05 will be considered statistically significant. The normality of continuous variables will be determined based on Shapiro-Wilks test values, normality tests, and histograms. The similarity of the experimental and control groups will be evaluated using the chi-square test for categorical variables and the t-test for continuous variables. The comparison of the levels of the outcome variables of the experimental and control groups before the intervention will be performed using the t-test. For the evaluation of repeated measurements (depressive symptoms, psychological flexibility, mindfulness, and value), a two-way analysis of variance will be used. For the evaluation of missing data, the Intention to Treat principle will be applied.
The study is planned to be conducted in a randomised controlled experimental design in accordance with CONSORT. The study is planned to be conducted between September 2025 and December 2026 at X Hospital with individuals who have completed cancer treatment. Individuals who are at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale will participate in the study. Individuals will be contacted by telephone and will first undergo a face-to-face interview. The psychoeducation sessions will be conducted online, individually, in approximately 30-minute sessions over 6 sessions. A total of 32 individuals will be included in the study, with 16 in the experimental group and 16 in the control group. Follow-ups will be conducted before the intervention, after the intervention, at 3 months, 6 months, and 12 months. No intervention will be performed on the control group during the application period, and they will be placed on a waiting list. If the intervention is found to be effective after the study is completed, it is planned to apply the programme to the volunteer participants in the control group.
The randomisation list will be concealed from participants, and each participant will be informed of their group assignment after being included in the study. Participants will be assigned to the experimental and control groups using the 'stratified randomisation' method based on their scores to determine which group they will be included in. To prevent study bias, the assignment of participants to the intervention and control groups will be conducted by an expert who is not involved in the study, in order to conceal the random assignment information.
In the study, participants will be asked to complete a demographic information form. Anxiety and depression levels will be measured using the Hospital Anxiety and Depression Scale (HADS). Psychological flexibility will be measured using the Acceptance and Action Questionnaire-II, mindfulness will be measured using the Mindfull Attention Awareness Scale, and the level of valuing will be measured using the Valuing Questionnaire. The validity and reliability of the scales have been established. Institutional permission has been obtained from the hospital where the study is being conducted. The study has been approved by the ethics committee of the relevant university. Additionally, verbal and written consent will be obtained from participants; individuals will be informed that information about them will not be shared with others and that the 'principle of confidentiality' will be adhered to. The costs of the study will be covered by the researcher.
- Conditions
- Cancer Breast, Colon Cancer, Cancer Survivors
- Being tested
- Experimental Group
- Keywords
- depression, anxiety, Mindfulness, Values, Acceptance and commitment approach, Psychological flexibility, cancer survivor
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupBehavioural
The experimental group will consist of 16 participants and the participants will receive internet-based environment psychoeducation for 6 weeks, each session for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | The control group will not receive any intervention during the application period and will be put on waitlist. |
| experimental/group | Experimental | The experimental group will consist of 16 participants and the participants will receive internet-based environment psychoeducation for 6 weeks, each session for 30 minutes. Receives: Behavioral: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is used to measure participants' anxiety and depression levels. In this scale (HADS), there are seven questions each to measure the dimensions of depression and anxiety. Each subscale consists of seven items with a 4-point ordinal response format. Scores ranges from 0 to 21 in each subscale, with higher scores indicating higher levels of anxious or depressive state. The scale has a four-point Likert-type. The cut-off points for the Turkish form of the HADS Scale are 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D).
Measured: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.
Secondary outcomes (3)
Acceptance and Action Questionnaire-II (AAQ-II)
The seven-item Acceptance and Action Questionnaire-II is a reliable and valid scale for measuring psychological flexibility in both clinical and non-clinical samples. The mean Cronbach Alpha coefficient was found to be .84, and the internal consistency was high.The questionnaire consists of seven items in total. The scale items are graded from 1 (never true) to 7 (always true). The lowest score to be taken from the scale is 7 and the highest score is 49. The AAQ-II is a seven-point Likert-type scale, and as the total score increases, psychological rigidity increases and psychological flexibility decreases.
Measured: Change from baseline psychological flexibility levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.
Mindful Attention Awareness Scale (MAAS)
Mindful Attention Awareness Scale was developed to measure the general level of mindfulness and attention to current processes in daily life. The Cronbach Alpha internal consistency coefficient calculated for the reliability of the scale is 0.80. The scale consists of 15 items. The lowest score that can be obtained from the scale is 15 and the highest 90. The scale is a 6-point Likert type scale: almost always (1), often (2), sometimes (3), rarely (4), rarely (5), almost never (6). The Mindful Attention Awareness Scale has a single factor and a single total score is obtained from the scale. As the score obtained from the scale increases, the level of mindfullness of the individual increases.
Measured: Change from baseline mindfulness levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.
The Valuing Questionnaire
The Valuing Questionnaire measures the extent to which people live in accordance with the value they have determined in the last week. The questionnaire is a Likert-type questionnaire consisting of 10 items and two sub-dimensions, "progression" and "obstruction". Progress sub-dimension emphasized being able to do daily tasks in line with values, while blocking sub-dimension emphasized living a life away from values in activities carried out for a week, unlike progress. The Cronbach's alpha value for the whole scale is 0.78. The lowest total score is zero, while the highest is 60. A high score indicates that individuals live a life in line with their values
Measured: Change from baseline valuing levels to the end point of the intervention and one month (4 weeks), six months (2.4 weeks), 12 months (48 weeks) after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start3 Nov 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Partlak Günüşen, Dokuz Eylul University
- Investigators
- Elif C Bulut, Msc, Principal investigator, Dokuz Eylul UniversityElif can Bulut, Msc, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205965
- Sponsor's protocol ID
- 8122-GOA
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
PubMed 27993338
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Anxiety, Depressive Symptoms, Psychological Flexibility, Mindfulness and Valuing in Cancer Survivors: A Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT07205965
- Acronym / sponsor ID
- 8122-GOA
- Conditions
- Cancer Breast, Colon Cancer, Cancer Survivors
- Keywords
- depression, anxiety, Mindfulness, Values, Acceptance and commitment approach, Psychological flexibility, cancer survivor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is planned to be conducted in a randomised controlled experimental design in accordance with CONSORT. The study is planned to be conducted between September 2025 and December 2026 at X Hospital with individuals who have completed cancer treatment. The randomisation list will be concealed from the participants, and each participant will be informed of which group they have been assigned to after being included in the study. The 'Stratified Randomisation' method will be used to determine which group participants will be assigned to, and participants will be included in the study based on their scores on the HAD scale. They will then be divided into experimental and control groups. To prevent study bias, the assignment of intervention and control groups will be conducted by an expert who has not participated in the study, with the aim of keeping the randomisation information confidential. The experimental group will consist of a total of 16 participants and will receive individual psychoeducation in an internet-based environment for 6 weeks, with each session lasting 30 minutes. No intervention will be made to the control group during the application period, and they will be placed on a waiting list. Participants who complete the psychoeducation will undergo follow-up measurements via an internet-based platform one month, six months, and one year after the psychoeducation, and their scores will be compared with those of the control group. The sample criteria include: having completed cancer treatment, having completed treatment for breast, gynaecological, colon or rectal cancer, having internet access, and being at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale. Exclusion criteria include receiving another psychosocial intervention, using psychiatric medication other than antidepressants, being in an advanced stage of cancer, having metastatic cancer, having recurrent cancer, and having started antidepressants in the last three months. Participants will be asked to complete a demographic information form. In addition, anxiety and depression levels will be measured using the Hospital Anxiety and Depression (HAD) scale. Psychological flexibility will be measured using the Acceptance and Action Questionnaire-II, mindfulness will be measured using the Mindfull Attention Awareness Scale, and the level of valuing will be measured using the Valuing Questionnaire. Validity and reliability studies have been conducted for the scales. Ethical committee approval has been obtained. Institutional approval has been obtained from the hospital where the study is being conducted.
Detailed description
According to World Health Organisation data, approximately one in six deaths is due to cancer (WHO, 2022). With the development of healthcare services, cancer survival rates are increasing and progress is being made in the treatment of the disease, but the physical and psychosocial effects of cancer on individuals continue (Li, Guo, Li \& Yang, 2021). In recent years, new approaches have been developed to support the mental well-being of cancer patients. The foremost of these is Acceptance and Commitment Therapy (ACT). ACT is an approach developed as a result of the interaction between empirical data obtained from scientific research on human behaviour and clinical experience. ACT, which comes from a humanistic model, emphasises awareness and self-compassion. As a behavioural therapy, ACT draws its origins from the perspectives of Skinner and Pavlov and is based on the Relational Frame Theory, which focuses on the nature of human language and cognitive processes. ACT aims to increase functionality and enable individuals to live more meaningful and valuable lives by using mindfulness. ACT intervention consists of six important cognitive processes. These are a therapeutic approach model consisting of values, contact with the present moment, cognitive defusion, acceptance, contextual self, and committed action. The aim of this study is to examine the effect of acceptance and commitment therapy-based psychoeducation applied to cancer survivors on individuals' anxiety, depressive symptoms, psychological flexibility, acceptance, value-oriented life, and awareness.
The study consists of survivors diagnosed with one of the following types of cancer: breast, gynaecological, colon, or rectal. Participants will be invited to join the study via telephone from the oncology unit's database, targeting patients who have completed these treatments within the past 1-12 months. Accepting patients will first be interviewed in person, and the HAD scale will be administered. Participants who meet the eligibility criteria will be included in the study. Inclusion criteria: - Being between 18 and 65 years of age, having completed cancer treatment, being able to speak Turkish, and, according to the Hospital Anxiety and Depression (HAD) scale, having distress in one or both of the depression or anxiety subscales (HAD-A ≥ 10 and/or HAD-D ≥ 7 based on the cut-off score), and having internet access. The exclusion criteria for the study are receiving another psychosocial intervention, cancer metastasis or recurrence, use of psychiatric medication other than antidepressants, and initiation of antidepressant treatment in the last three months.
The aim of this study is to examine the effect of acceptance and commitment therapy-based psychoeducation applied to cancer survivors on individuals' anxiety, depressive symptoms, psychological flexibility, acceptance, value-oriented life, and awareness.
For the sample calculation required for the study, the G power statistical analysis programme was used, with a Type I error of 0.05, a Type II error of 0.20 (power 0.80), and an effect size of 0.25, and an ANOVA test was applied. Anticipating possible losses in the sample, a total of 32 participants, 16 in each group, are planned to be included. In the data analysis of the study, descriptive statistics will be expressed as numbers (n) and percentages (%) for discrete variables and as mean ± standard deviation (minimum-maximum) for continuous variables. In all analyses, p-values less than 0.05 will be considered statistically significant. The normality of continuous variables will be determined based on Shapiro-Wilks test values, normality tests, and histograms. The similarity of the experimental and control groups will be evaluated using the chi-square test for categorical variables and the t-test for continuous variables. The comparison of the levels of the outcome variables of the experimental and control groups before the intervention will be performed using the t-test. For the evaluation of repeated measurements (depressive symptoms, psychological flexibility, mindfulness, and value), a two-way analysis of variance will be used. For the evaluation of missing data, the Intention to Treat principle will be applied.
The study is planned to be conducted in a randomised controlled experimental design in accordance with CONSORT. The study is planned to be conducted between September 2025 and December 2026 at X Hospital with individuals who have completed cancer treatment. Individuals who are at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale will participate in the study. Individuals will be contacted by telephone and will first undergo a face-to-face interview. The psychoeducation sessions will be conducted online, individually, in approximately 30-minute sessions over 6 sessions. A total of 32 individuals will be included in the study, with 16 in the experimental group and 16 in the control group. Follow-ups will be conducted before the intervention, after the intervention, at 3 months, 6 months, and 12 months. No intervention will be performed on the control group during the application period, and they will be placed on a waiting list. If the intervention is found to be effective after the study is completed, it is planned to apply the programme to the volunteer participants in the control group.
The randomisation list will be concealed from participants, and each participant will be informed of their group assignment after being included in the study. Participants will be assigned to the experimental and control groups using the 'stratified randomisation' method based on their scores to determine which group they will be included in. To prevent study bias, the assignment of participants to the intervention and control groups will be conducted by an expert who is not involved in the study, in order to conceal the random assignment information.
In the study, participants will be asked to complete a demographic information form. Anxiety and depression levels will be measured using the Hospital Anxiety and Depression Scale (HADS). Psychological flexibility will be measured using the Acceptance and Action Questionnaire-II, mindfulness will be measured using the Mindfull Attention Awareness Scale, and the level of valuing will be measured using the Valuing Questionnaire. The validity and reliability of the scales have been established. Institutional permission has been obtained from the hospital where the study is being conducted. The study has been approved by the ethics committee of the relevant university. Additionally, verbal and written consent will be obtained from participants; individuals will be informed that information about them will not be shared with others and that the 'principle of confidentiality' will be adhered to. The costs of the study will be covered by the researcher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –The control group will not receive any intervention during the application period and will be put on waitlist. |
| experimental/group | Experimental | Behavioral: Experimental GroupThe experimental group will consist of 16 participants and the participants will receive internet-based environment psychoeducation for 6 weeks, each session for 30 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having completed cancer treatment, having completed treatment for breast, gynaecological, colon or rectal cancer, having internet access, and being at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale.
Key exclusion criteria (1 listed)
- receiving another psychosocial intervention, using psychiatric medication other than antidepressants, being in an advanced stage of cancer, having metastatic cancer, having recurrent cancer, and having started antidepressants in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupThe experimental group will consist of 16 participants and the participants will receive internet-based environment psychoeducation for 6 weeks, each session for 30 minutes. | Behavioural | experimental/group |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.
The Hospital Anxiety and Depression Scale (HADS) is used to measure participants' anxiety and depression levels. In this scale (HADS), there are seven questions each to measure the dimensions of depression and anxiety. Each subscale consists of seven items with a 4-point ordinal response format. Scores ranges from 0 to 21 in each subscale, with higher scores indicating higher levels of anxious or depressive state. The scale has a four-point Likert-type. The cut-off points for the Turkish form of the HADS Scale are 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D).
3 secondary outcomes
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: Change from baseline psychological flexibility levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.
Mindful Attention Awareness Scale (MAAS)
Time frame: Change from baseline mindfulness levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.
The Valuing Questionnaire
Time frame: Change from baseline valuing levels to the end point of the intervention and one month (4 weeks), six months (2.4 weeks), 12 months (48 weeks) after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 27993338Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif C Bulut, Msc principal investigator
Dokuz Eylul University
Elif can Bulut, Msc principal investigator
Dokuz Eylul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Cancer Breast and Colon Cancer, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07205965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.