Clinical trial NCT05963412: Online Individual Intervention Program to Make Sense of People's Experiences After a Breast Cancer Diagnosis
Official title: Developing an Online Individual Intervention Program to Make Sense of People's Experiences After a Breast Cancer Diagnosis and Examining Its Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
meaning making
online intervention program
psychological health
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Folkman's 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 individual's 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 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 3)Compared 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: 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, 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.

Eligibility criteria: Inclusion criteria:

* Age between 18 and 65 years
* Being a woman
* Being a native Turkish speaker
* Diagnosed with stage I, II, or III breast cancer
* Diagnosed for at least 6 months and at most 3 years
* Being able to video-conference using a desktop computer, a laptop, or a tablet

Exclusion criteria:

* Having any psychiatric diagnosis or currently using psychiatric medication,
* Currently receiving psychological support,
* Having a history of cancer diagnosis
* Having a diagnosis of advanced stage (stage ıv) breast cancer
* Having a concurrent diagnosis of another cancer.

Primary outcomes:
measure: Socio-demographic and Disease-Related Information Form
timeFrame: Baseline (before the intervention program begins)
measure: Change in the Meaning in Life Questionnaire
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up
measure: Change in Post-traumatic Growth Inventory-X
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
Secondary outcomes:
measure: Change in The Stress Appraisal Measure
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
measure: Change in Global Meaning Violation Scale
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
measure: Change in The Impact of Event Scale-Revised
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
measure: Change in Acceptance and Action Questionnaire-II
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
measure: Change in The Hospital Anxiety and Depression Scale
timeFrame: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University, Faculty of Letters
Study officials:
affiliation: Dokuz Eylul University
name: Selva Ülbe
role: PRINCIPAL_INVESTIGATOR
References: