NeoplasmsNCT05187130
The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients
A study testing Mindfulness in people with Neoplasms and Cancer, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2021to 22 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older,
- volunteering to participate in the study,
- conscious and not having communication problems,
- not taking any course on anxiety, tension, depression symptoms and coping with stress
Who cannot join
- Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression) • Take another psychological relaxation course or training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients: Single Blinded Randomized Controlled Study
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.
Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or practice (intervention?) on anxiety, tension, depression symptoms and coping with stress were included in the study. Participitants randomised intervention and controlled groups.
Read the detailed description
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.
Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or intervention on anxiety, tension, depression symptoms and coping with stress were included in the study.
Sample size and randomization The sample number was calculated using the GPower 3.1.9 version program. At an effect size of 0.5 and an error level of 0.05 [alpha], the required sample size was determined to be at least 54 individuals for each group. A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature (Lee et al., 2020). The power of the analysis made with this sample size was determined as 93.1%. Considering the losses during the study, the sample number for each group was determined as 60 people.
The groups of participants who agreed to participate in the study were determined by the program with the randomization URL http://www.randomization.com/. In order to distribute the numbers to the groups, the numbers from 1 to 120 were randomly assigned to the two groups, assuming that set 1 would represent the intervention group and set 2 would represent the control group. In line with the program, the order of the patients forming the sample group was determined by randomization. A total of 130 patients, 65 in the intervention group and 65 in the control group, were included in the study. 5 participants in the intervention group who did not want to participate and died during the study, and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation. In the study, the results of a total of 120 patients, 60 in the intervention group and 60 in the control group, were analyzed.
Measures/Instruments Participant Information Form, State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale were used to collect research data. Survey Monkey was used as the data collection method. The Survey Monkey survey was created, which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person. Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses.
- Being tested
- Mindfulness
- Keywords
- Stress, Psychological, Depression, Anxiety Disorders
- Medical subject headings
- Neoplasms, Stress, Psychological, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessOther
60 patients in the mindfulness-based breathing and music therapy group were divided into subgroups of 5 participants each. Each 6-person group started by having participants complete the pretest State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale via Survey Monkey. Mindfulness-based breathing and music therapy was applied to each patient group in approximately 45-minute sessions per day. At the end of the session, participants re-filled the posttest State Anxiety Inventory, Work-Related Tension Scale, and Psychological Well-Being Scale. A total of 3 sessions were completed with an interval of two days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mindfulness-based breathing and music therapy Receives: Other: Mindfulness |
| Control | No intervention | No intervention has been made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information Form
This form was developed by the researchers to include the age, gender, marital status, educational status, and treatment method of the participants.
Measured: Baseline
State Anxiety Inventory
The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).
Measured: Baseline
State Anxiety Inventory
The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).
Measured: at the end of week 1
Psychological Well-Being Scale
The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.
Measured: baseline
Psychological Well-Being Scale
The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.
Measured: at the end of week 1
Beck Depression Inventory
Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.
Measured: baseline
Beck Depression Inventory
Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.
Measured: at the end of week 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start20 Jul 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Aydın University
- Investigators
- Dilek YILDIRIM, Ph.D, Study director, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187130
- Sponsor's protocol ID
- Cancer patients mindfulness
- Status last verified
- May 2023
- First submitted
- 24 Dec 2021
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients: Single Blinded Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05187130
- Acronym / sponsor ID
- Cancer patients mindfulness
- Keywords
- Stress, Psychological, Depression, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 11 Jan 2022 (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.
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.
Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or practice (intervention?) on anxiety, tension, depression symptoms and coping with stress were included in the study. Participitants randomised intervention and controlled groups.
Detailed description
Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.
Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or intervention on anxiety, tension, depression symptoms and coping with stress were included in the study.
Sample size and randomization The sample number was calculated using the GPower 3.1.9 version program. At an effect size of 0.5 and an error level of 0.05 [alpha], the required sample size was determined to be at least 54 individuals for each group. A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature (Lee et al., 2020). The power of the analysis made with this sample size was determined as 93.1%. Considering the losses during the study, the sample number for each group was determined as 60 people.
The groups of participants who agreed to participate in the study were determined by the program with the randomization URL http://www.randomization.com/. In order to distribute the numbers to the groups, the numbers from 1 to 120 were randomly assigned to the two groups, assuming that set 1 would represent the intervention group and set 2 would represent the control group. In line with the program, the order of the patients forming the sample group was determined by randomization. A total of 130 patients, 65 in the intervention group and 65 in the control group, were included in the study. 5 participants in the intervention group who did not want to participate and died during the study, and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation. In the study, the results of a total of 120 patients, 60 in the intervention group and 60 in the control group, were analyzed.
Measures/Instruments Participant Information Form, State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale were used to collect research data. Survey Monkey was used as the data collection method. The Survey Monkey survey was created, which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person. Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses.
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 |
|---|---|---|
| Intervention | Experimental | Other: MindfulnessMindfulness-based breathing and music therapy |
| Control | No intervention | –No intervention has been made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- volunteering to participate in the study,
- conscious and not having communication problems,
- not taking any course on anxiety, tension, depression symptoms and coping with stress
Key exclusion criteria (1 listed)
- Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression) • Take another psychological relaxation course or training
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 |
|---|---|---|
| Mindfulness60 patients in the mindfulness-based breathing and music therapy group were divided into subgroups of 5 participants each. Each 6-person group started by having participants complete the pretest State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale via Survey Monkey. Mindfulness-based breathing and music therapy was applied to each patient group in approximately 45-minute sessions per day. At the end of the session, participants re-filled the posttest State Anxiety Inventory, Work-Related Tension Scale, and Psychological Well-Being Scale. A total of 3 sessions were completed with an interval of two days. | Other | Intervention |
Primary outcome
Information Form
Time frame: Baseline
This form was developed by the researchers to include the age, gender, marital status, educational status, and treatment method of the participants.
State Anxiety Inventory
Time frame: Baseline
The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).
State Anxiety Inventory
Time frame: at the end of week 1
The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).
Psychological Well-Being Scale
Time frame: baseline
The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.
Psychological Well-Being Scale
Time frame: at the end of week 1
The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.
Beck Depression Inventory
Time frame: baseline
Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.
Beck Depression Inventory
Time frame: at the end of week 1.
Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
Dilek YILDIRIM, Ph.D study director
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Neoplasms and Cancer, run by Istanbul Aydın University at 1 site 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 4 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: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Information Form (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2023.