Posttraumatic GrowthNCT06279806
The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer
A study testing Mobile health application use and Information of the breast cancer survivor period booklet in people with Posttraumatic Growth and Grief, run by Gazi University.
Trial summary
Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Growth, Grief
- What is being tested?
- Mobile health application use and Information of the breast cancer survivor period booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2024to 30 Oct 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Diagnosed with breast cancer Stage I-II-III-IV
- Having undergone breast cancer surgery
- To have completed cancer treatment,
- Being at the beginning of the remission period,
- Being able to read and write
- Having a cell phone with Android software
Who cannot join
- Having a diagnosed psychiatric illness,
- Receiving hormone therapy only,
- Having had any cancer before,
- Having a communication barrier (not speaking Turkish, speech/hearing impairment, etc.)
- Being visually impaired
- Criteria for Exclusion from the Sample During the Study
Show all 10Show fewer
- Not logging into the information and counseling panel of the mobile health application
- Wanting to leave study
- Failure to complete final tests
- Death of the participant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Mobile Health Application Based on Transformational Learning Theory on Posttraumatic Growth in Women Diagnosed With Breast Cancer
Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses.
- Conditions
- Posttraumatic Growth, Grief
- Being tested
- Mobile health application use, Information of the breast cancer survivor period booklet
- Keywords
- mobile health application, posttraumatic growth, grief, breast cancer, breast cancer survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health application useOther
Women will be asked to use the app for at least 8 weeks. In order to monitor the usage, the researcher will monitor whether the women log in to the "Information and Counseling" section from the admin panel. Women who do not log in to the "Information and Counseling" section will be removed from the study at this stage. A weekly reminder will be sent to women via the mobile application. The questions asked by the participants through the question-and-answer section of the mobile health application will be examined every day and answered by the researcher between 10:00-11:00 every morning and 22:00-23:00 every evening. Likewise, the content shared by women in the forum section of the mobile application will be checked daily by the researcher and content that is harmful to women will be removed.
Information of the breast cancer survivor period bookletOther
Women in the control group will be given information of the breast cancer survivor period booklet.
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | Mobile health application use Receives: Other: Mobile health application use |
| Control Group | Experimental | Information of the breast cancer survivor period booklet Receives: Other: Information of the breast cancer survivor period booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's progression through the stages of grief
Mean scores on the Grief Psychological Reactions to Loss of Health Scale Psychological Reactions Scale due to Loss of Health: The scale has 30 items and is a 5-point Likert type (1: never, 5: always). The scale does not have a total score. Evaluation is made according to the scores obtained from the sub-dimensions. It is seen that as the score obtained from the sub-dimensions increases, there is an increase in the number of people experiencing each of the stages of grief. The scale has two different evaluations and two different subscale ratings.
Measured: 12 week
Secondary outcomes (1)
Women's increased level of posttraumatic development
Post-Traumatic Development Scale in Cancer Patients: The scale consists of 23 Likert-type scale items scored between 0-5. It is evaluated between "0" (I have never experienced it) and "5" (I have experienced it a lot). The lowest score to be obtained from the scale is 0, the highest score is 115, and the higher the score obtained from the scale, the more the individual develops after the trauma.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Feb 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic GrowthStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Model description
- In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279806
- Sponsor's protocol ID
- SerapAlkas
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Health Application Based on Transformational Learning Theory on Posttraumatic Growth in Women Diagnosed With Breast Cancer
- ClinicalTrials.gov ID
- NCT06279806
- Acronym / sponsor ID
- SerapAlkas
- Conditions
- Posttraumatic Growth, Grief
- Keywords
- mobile health application, posttraumatic growth, grief, breast cancer, breast cancer survivor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website.
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Other: Mobile health application useMobile health application use |
| Control Group | Experimental | Other: Information of the breast cancer survivor period bookletInformation of the breast cancer survivor period booklet |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Being over 18 years of age
- Diagnosed with breast cancer Stage I-II-III-IV
- Having undergone breast cancer surgery
- To have completed cancer treatment,
- Being at the beginning of the remission period,
Key exclusion criteria (10 listed)
- Having a diagnosed psychiatric illness,
- Receiving hormone therapy only,
- Having had any cancer before,
- Having a communication barrier (not speaking Turkish, speech/hearing impairment, etc.)
- Being visually impaired
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 |
|---|---|---|
| Mobile health application useWomen will be asked to use the app for at least 8 weeks. In order to monitor the usage, the researcher will monitor whether the women log in to the "Information and Counseling" section from the admin panel. Women who do not log in to the "Information and Counseling" section will be removed from the study at this stage. A weekly reminder will be sent to women via the mobile application. The questions asked by the participants through the question-and-answer section of the mobile health application will be examined every day and answered by the researcher between 10:00-11:00 every morning and 22:00-23:00 every evening. Likewise, the content shared by women in the forum section of the mobile application will be checked daily by the researcher and content that is harmful to women will be removed. | Other | İntervention Group |
| Information of the breast cancer survivor period bookletWomen in the control group will be given information of the breast cancer survivor period booklet. | Other | Control Group |
Primary outcome
Women's progression through the stages of grief
Time frame: 12 week
Mean scores on the Grief Psychological Reactions to Loss of Health Scale Psychological Reactions Scale due to Loss of Health: The scale has 30 items and is a 5-point Likert type (1: never, 5: always). The scale does not have a total score. Evaluation is made according to the scores obtained from the sub-dimensions. It is seen that as the score obtained from the sub-dimensions increases, there is an increase in the number of people experiencing each of the stages of grief. The scale has two different evaluations and two different subscale ratings.
1 secondary outcome
Women's increased level of posttraumatic development
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health application use and Information of the breast cancer survivor period booklet in people with Posttraumatic Growth and Grief, run by Gazi University.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serap ALKAŞ, Research Assistant (+90 554 877 88 02, serapalkas11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's progression through the stages of grief (time frame: 12 week). 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 28 Feb 2024.