Online Group Therapy for Breast Cancer
Investigation of the Effectiveness of an Online Group Therapy Program for Post-Traumatic Growth in Women With Breast Cancer
1 other identifier
interventional
51
1 country
1
Brief Summary
Breast cancer is a serious and life-threatening health problem that is increasing all over the world and in Turkey. Although the survival rate increases with the improvement of the diagnosis and treatment processes for breast cancer, cancer patients experience some psychosocial problems both due to their treatment and the disease. Decreases in quality of life, psychological distress, especially depression and anxiety, post-traumatic stress disorder as well as sleep disorders, fatigue, fear of cancer recurrence could be common negative outcomes that experienced by the breast cancer patients. Although, cancer could be such a life-threatening disease, some patients report that they experience positive changes in their lives after the diagnosis of cancer. The concept of Post-Traumatic Growth (PTG) was first developed by Tedeschi and Calhoun (1995). PTG is a concept that refers positive psychological changes after struggling an stressful life event. According to the Functional-Descriptive model of Tedeschi and Calhoun, post-traumatic growth occurs in five areas; relating to others, personal strength, spiritual changes and appreciation of life. In this context, a group intervention program has been developed for PTG, which will bring the person to a better functionality than before the trauma to enhance the Post-Traumatic Growth level of women with breast cancer. The current research project will consist of three arms; therapy group, support group and wait-list. Online group therapy consists of eight sessions that continue approximately 90 minutes. In addition to an active treatment group for PTG, an online support group has been developed by the researchers to investigate the effectiveness of the therapy. Online support group also consists of eight sessions during approximately 90 minutes as in intervention program. Wait-list is considered as a control group. A set of reliable and validated measurement tools will be administered and heart rate variability as a physical measurement will be used to examine the effects of the therapy. The research hypotheses are based on that patients who participated active treatment group will have better PTG level and other related concept with PTG (like higher score of deliberate rumination) and better Heart-Rate Variability scores than other groups. The researcher will plan to take three time measurement: pre-intervention, post-intervention, and 1-month follw-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jan 2022
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2022
CompletedFirst Submitted
Initial submission to the registry
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedFebruary 28, 2022
February 1, 2022
9 months
February 7, 2022
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Post-traumatic Growth Inventory
The Turkish version of Post-traumatic Growth Inventory to measure PTG levels of the patients will be used. It is compromised of 21 item and scored ranging from 0 to 5. Higher scores refer higher PTG level.
Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Event-Related Rumination Inventory (ERRI)
The Turkish version of Event-Related Rumination Inventory (ERRI) that is reliable and validated measure will be used to assess rumination of the breast cancer. It has 20 items and two sub-scale; intrusive and deliberate rumination. The scores are changing from 0 to 3.
Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8 (after completing eight-week intervention), and 1-month follow-up.
PTSD Checklist for DSM-5 (PCL-5)
It will be used to asses stressful level of breast cancer to participate the treatment programs.The 20-item self-report measure of PTSD scored from 0 to 4, and yielding a scale score range of 0-80.
Baseline measurement to deciding to join the treatment programs
Secondary Outcomes (3)
Change in Depression Anxiety and Stress Scale (DASS-21)
Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Heart-Rate Variability
Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Distress Disclosure Index
Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Study Arms (3)
Online Group Therapy for PTG
EXPERIMENTALIt consists of eight sessions that occur during app. 90 minutes. A group therapist and a cotherapist will lead the therapy sessions. There will be one session per a week.
Online Support Group
ACTIVE COMPARATORIt consists of eight sessions that occur during app. 90 minutes. A group therapist and a cotherapist will lead the therapy sessions without using any psychological methods. There will be one session per a week.
Wait-list
NO INTERVENTIONWe used a wait-list as a control group. After each participants in both online PTG group therapy and online support group completed the interventions, wait-list will be randomly assigned to one of these two interventions.
Interventions
Online Group Therapy for PTG consists of eight sessions. Each sessions have specific themes. First session: psychoeducation, normalization of the experiences and emotions. Second session: emotion regulation skills. Third session: awareness of the negative thoughts that make patients worried, anxious, feared. Forth session: restructuring of the thoughts and practicing mindfulness technics. 5. session: practicing of self-disclosure skills 6. session: creating a breast cancer story with balancing losses and gains. 7. session: sharing of the effects of breast cancer on life and developing new life priorities 8. session: making life meaning and developing new life goals.
Online support groups also consist of eight sessions. 1. session: introducing the program and learning the expectancies 2. session: sharing what is known about breast cancer 3. session: risk and protective factors for breast cancer 4. session: sharing side effects of surgical operation and treatments 5. session: sharing the reactions of family, close friends 6. session: patient-doctor relationship and also sharing the challenges and facilitators of healthcare system 7. session: sharing the current position in the treatment and of what has been done for improvement 8. session: sharing the reliable information sources for breast cancer and close
Eligibility Criteria
You may qualify if:
- women who have been diagnosed with breast cancer for the first and only
- women who have been diagnosed breast cancer in 2018 and later (past four years)
- stage I, II and III patients
- ability to use internet
- having a personal computer or tablet with a camera and microphone
- describing cancer as a stressful life event (using PCL-5 to assess post-traumatic stress level)
You may not qualify if:
- recurrence of breast cancer,
- second cancer,
- severe psychological or physical comorbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eskişehir Osmangazi University Faculty of Medicine
Eskişehir, 26040, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cennet Yastıbaş-Kaçar, MD
Dokuz Eylul University
Central Study Contacts
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
- Research Assistant, PhD candidate, clinical psychologist
Study Record Dates
First Submitted
February 7, 2022
First Posted
February 28, 2022
Study Start
January 15, 2022
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
February 28, 2022
Record last verified: 2022-02