Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963412
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-19
Brief Title:
Online Individual Intervention Program to Make Sense of Peoples Experiences After a Breast Cancer Diagnosis
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Developing an Online Individual Intervention Program to Make Sense of Peoples Experiences After a Breast Cancer Diagnosis and Examining Its Effectiveness
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
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:
The unexpected changes caused by the diagnosis and treatment of breast cancer can lead individuals to question their beliefs life meanings and goals prompting a search for meaning According to Park and Folkmans Meaning-Making Model the process of meaning making functions as a coping mechanism It helps individuals adapt challenging experiences into their lives ultimately assisting in their psychological adjustment to stressful situations Based on this theoretical model principles from meaning therapy literature reviews interviews with breast cancer patients and expert consultation an 8-week online individual psychological intervention was developed It was aimed at facilitating the finding of new meanings in the experience of breast cancer and promoting psychological well-being It includes psycho-educational cognitive existential and behavioral components explicitly focusing on the meaning-making process This intervention is called the Meaning Centered Coping Program MCCP The main purpose of this study was to test whether the MCCP was an effective intervention program for women diagnosed with breast cancer For this purpose the study sample consisted of women with stage I II and III breast cancer Then participants were randomly assigned to the MCCP group and the waitlist control group A number of reliable and valid measurement tools were used to compare the MCCP group with the waitlist control group and to examine the effect of the program Compared with the control group significant improvements were expected in the level of meaning in life post-traumatic growth situational meanings and psychological well-being in the MCCP group
Detailed Description:
In recent years there has been a growing discussion about the necessity for mental health services not only to alleviate individuals psychological distress but also to focus on enhancing the sense of meaning in life Therefore the MCCP aimed not only to reduce distressing psychological symptoms but also to facilitate the discovery of new positive meanings in breast cancer and individuals life despite existing limitations In this regard the MCCP has been developed by drawing upon Meaning-Making Model principles of meaning therapy the literature on meaning and existing meaning centered psychotherapy approaches Additionally considering limitations such as potential program changes transportation difficulties and inadequate physical conditions online interventions offer a reliable alternative that provides numerous advantages for individuals diagnosed with breast cancer Therefore the intervention program was implemented online via video conference for women diagnosed with breast cancer in the current study After the program was developed a pilot study was conducted According to the experts feedback the final version of MCCP was developed The primary aim was to test the effectiveness of MCCP among women with breast cancer The research hypotheses are 1 compared to control grup MCCP group would show better improvement in meaning in life and PTG scores 2 compared to control grup MCCP group would show better improvements in situational meaning ie stress appraisal 3Compared to control group the MCCP group would report a significantly lower level of psychological distress
Before the data collection process ethical approval was obtained from the Institutional Ethics Committee of Dokuz Eylül University affiliated with Dokuz Eylül University School of Medicine Ethics Committee Decision No 202112-39 The study has been announced using social media platforms Facebook Twitter Instagram oncology associations established to support oncology patients and referrals from healthcare professionals to reach potential participants The sample size was determined using the power analysis method Then 44 women diagnosed with breast cancer who volunteered to participate in the study were randomly assigned to either the intervention group or the waitlist control group
The random assignment process was conducted using the website httpswwwrandomizerorg Participants in the MCCP group were assessed thrice before the intervention immediately after the intervention and at the 2-month follow-up The control group underwent the initial assessment before intervention began and the final assessment took place eight weeks later After getting verbal and written consent from all participants a number of measurement tools was applied The Sociodemographic and Disease-Related Information Form The Meaning in Life Questionnaire Posttraumatic Growth Inventory-X Stress Appraisal Measure and Hospital Anxiety and Depression Scale were used To test the hypotheses of the study Pearson correlation analysis 2 Group X 2 Time repeated measures ANOVA and one-way repeated measures ANOVA were applied SPSS 290 Package Program for Social Sciences was used for statistical analyses
Before the data collection process ethical approval was obtained from the Institutional Ethics Committee of Dokuz Eylül University affiliated with Dokuz Eylül University School of Medicine Ethics Committee Decision No 202112-39 The study has been announced using social media platforms Facebook Twitter Instagram oncology associations established to support oncology patients and referrals from healthcare professionals to reach potential participants The sample size was determined using the power analysis method Then 44 women diagnosed with breast cancer who volunteered to participate in the study were randomly assigned to either the intervention group or the waitlist control group
The random assignment process was conducted using the website httpswwwrandomizerorg Participants in the MCCP group were assessed thrice before the intervention immediately after the intervention and at the 2-month follow-up The control group underwent the initial assessment before intervention began and the final assessment took place eight weeks later After getting verbal and written consent from all participants a number of measurement tools was applied The Sociodemographic and Disease-Related Information Form The Meaning in Life Questionnaire Posttraumatic Growth Inventory-X Stress Appraisal Measure and Hospital Anxiety and Depression Scale were used To test the hypotheses of the study Pearson correlation analysis 2 Group X 2 Time repeated measures ANOVA and one-way repeated measures ANOVA were applied SPSS 290 Package Program for Social Sciences was used for statistical analyses
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