Online Individual Intervention Program to Make Sense of People's Experiences After a Breast Cancer Diagnosis

NCT05963412 | Completed

• 1 other identifier: MeaningInt-BreastCancer
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; meaning making; online intervention program; psychological health

Outcome Measures

Primary Outcomes (3)

• Socio-demographic and Disease-Related Information Form

  This form is a questionnaire designed to gather socio-demographic characteristics and information related to the diagnosis of breast cancer from the participants. Socio-demographic questions include the participant's age, educational level, occupation, income level, marital status, the number of children, and health insurance coverage. The questions related to breast cancer include the time since diagnosis, clinical stage of breast cancer, duration of treatment, completed treatment, type of surgical interventions, cancer history and menstrual status.

  Baseline (before the intervention program begins)

• Change in the Meaning in Life Questionnaire

  The Meaning in Life Scale was developed to measure individuals' level of meaning and purpose in life (Steger et al., 2006) The scale consists of a total of ten items and comprises two dimensions: the presence of meaning and the search for meaning. The scale is assessed using a 7 point scale scored from 1 to 7. The Turkish version of The Meaning in Life Questionnaire, adapted by Akin and Taş (2015), was used in this study. Psychometric features of the Turkish version of the scale indicated that it was a valid and reliable measurement tool.

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up

• Change in Post-traumatic Growth Inventory-X

  The Posttraumatic Growth Inventory (PTGI) is developed to assess positive changes experienced following traumatic life events. In this study, the Posttraumatic Growth Inventory-X (PTGI-X) was used (Tedeschi et al., 2017). The inventory consists of 25 items and is scored on a six-point scale scored from 0 to 5. Higher scores on the inventory indicated higher levels of posttraumatic growth. The Psychometric properties of the inventory are sufficient to measure the level of post-traumatic growth.

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

Secondary Outcomes (5)

• Change in The Stress Appraisal Measure

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

• Change in Global Meaning Violation Scale

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

• Change in The Impact of Event Scale-Revised

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

• Change in Acceptance and Action Questionnaire-II

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

• Change in The Hospital Anxiety and Depression Scale

  Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

Study Arms (2)

Online Individual Intervention Program

EXPERIMENTAL

The online intervention program (namely, Meaning-Centered Coping Program) consists of eight individual sessions, each lasting approximately 60 min. Sessions were conducted per week.

Other: Meaning Centered Coping Program

No Intervention: Waitlist Control Group

NO INTERVENTION

A wait-list control group was used. Participants assigned to the wait-list control group did not receive the intervention immediately. After the final assessment was administered (eight weeks later since the initial assessment), they were able to participate in the same intervention program if they wanted.

Interventions

Meaning Centered Coping Program OTHER

Meaning Centered Coping Program is a psychological intervention program developed for women diagnosed with breast cancer, based on the Meaning Making Model (Park, 2010; Park and Folkman, 1997) and Wong's (2010) principles of Meaning Therapy. Each weekly session had specific topics. These are: Session 1: Guiding patients to tell the story of their breast cancer and psycho-education; Session 2: Encouraging patients to talk about the effects of breast cancer on their lives and learning to accept their difficult emotions; Session 3: Focusing on cognition through the meaning attributed to breast cancer; Session 4: Learning to take alternative perspectives and defusing their negative thoughts; Session 5: Exploring personal strengths; Session 6: İdentifying important life values and moving toward value-based actions; Session 7: Finding meaning in breast cancer and life; Session 8: Focusing on Future plans and hopes

Online Individual Intervention Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The study included women diagnosed with breast cancer. In this regard, biological sex was considered.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University, Faculty of Letters

Izmir, 35390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Personal Satisfaction; Behavior

Study Officials

• Selva Ülbe

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: October 30, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)