Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05963412 |
Other study ID # |
MeaningInt-BreastCancer |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 30, 2021 |
Est. completion date |
December 30, 2022 |
Study information
Verified date |
July 2023 |
Source |
Dokuz Eylul University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 Folkman's (1997) 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 (Wong, 2010),
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 wait-list
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, psychological inflexibility, and psychological
well-being in the MCCP group.
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 individual's life, despite existing limitations. In this
regard, the MCCP has been developed by drawing upon Meaning-Making Model (Park, 2010; Park
and Folkman,1997), principles of meaning therapy (Wong, 2010), 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
expert's 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
(i.e. stress appraisal and violations in general meaning) 3) Compared to control group, the
MCCP group would report significant decrease in automatic meaning making efforts (i.e.
intrusion and avoidance) 4) Compared to control group, the MCCP group would report a
significantly higher level of psychological flexibility and 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: 2021/12-39). 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 https://www.randomizer.org/.
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, Global Meaning
Violations Scale, Impact of Event Scale-Revised Form, Acceptance and Action Scale-II, 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 29.0 Package Program for Social Sciences was used for
statistical analyses.