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Online Group Therapy for Breast Cancer

NCT ID: NCT05259267

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Preliminary studies to development of the programs Before the development of protocol of the current treatment programs, the investigators reviewed related literature and published a systematic review about the related factors for PTG in women with breast cancer. After obtaining the ethical approval the study coordinator interviewed with eight women via telephone to explore the experiences of women with breast cancer. The investigators determined the needs and possible challenges of the illness. Besides, previous similar treatment programs were examined in detail. Later, the investigator developed the study protocol with the supervisor and send the content of the treatment programs to five specialists who have MD in clinical psychology and got feedback and the investigators revisited final version of the treatment programs.

In brief, the research hypotheses are 1) both online group therapy for PTG and online support groups will show better PTG levels and rumination scores, and other secondary measurements (such as psychological distress, heart rate variability, disclosure of distress) than wait-list control. 2) Participants who in online group therapy for PTG will improve better PTG and rumination scores, and secondary measurements' scores compared with the participants in online support groups. 3) The benefits of the treatment programs will be endured for 1-month follow-up measure.

Procedure Ethical approval: This study was approved by the institutional review board of Eskisehir Osmangazi University. All study participants gave written informed consent. Announcements will be posted in various departments of the hospital to participate in the research. First of all, volunteer participants will be assessed through the phone and informed about the research process. If they agree to participate, the investigators will organize a detailed interview. In this interview one of the researchers of the study who is a psychiatrist will apply SCID to eliminate the other possible mental disorder. Patients who meet the criteria will be informed about the group and informed consent forms will be obtained. Before beginning of the treatment program, baseline measurement and ECG Holter measurement will be scheduled by the telephone. After completing baseline measurement, the participants will then be randomly allocated to one of the three groups.

The online treatment programs will be delivered to groups of 6-8 participants by a psychologist and psychiatrist (therapist and co-therapist), eight weekly online sessions. Online sessions will be delivered through an online video-conferencing software (ZOOM). Sample size is determined by g-power analysis. For three-arm randomized controlled trial we plan to recruit at least 51 participants (each group should have at least 17 participants). Before the beginning of the study, the participants will be informed about online video-conferencing platform. The investigators will send a video about the use of platform and also step by step user manual. Each participant in treatment programs should join at least six sessions. If the participants could not complete six sessions, the investigators will admit them drop-out (This information will be declared during the interviews and written informed consent). The investigators will use SPSS 23.0 Package Program for Social Sciences. The descriptive analysis will be performed for frequencies of socio-demographics and clinical information such as cancer stage, treatments. To test the hypothesis, the investigators will conduct a repeated measure ANOVA. The investigators will employ intention to treat and as treated analysis.

Conditions

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Breast Cancer

Keywords

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breast cancer post-traumatic growth online group therapy online support groups

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online Group Therapy for PTG

It 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.

Group Type EXPERIMENTAL

Online Group Therapy for PTG

Intervention Type BEHAVIORAL

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 Group

It 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.

Group Type ACTIVE_COMPARATOR

Online Support Group

Intervention Type BEHAVIORAL

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

Wait-list

We 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Online Group Therapy for PTG

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.

Intervention Type BEHAVIORAL

Online Support Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* recurrence of breast cancer,
* second cancer,
* severe psychological or physical comorbidity
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Cennet Yastıbaş

Research Assistant, PhD candidate, clinical psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cennet Yastıbaş-Kaçar, MD

Role: STUDY_CHAIR

Dokuz Eylul University

Locations

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Eskişehir Osmangazi University Faculty of Medicine

Eskişehir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Cennet Yastıbaş-Kaçar, MD

Role: CONTACT

Phone: +905346320490

Email: [email protected]

Facility Contacts

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Cennet Yastıbaş-Kaçar, MD

Role: primary

Other Identifiers

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121K686

Identifier Type: -

Identifier Source: org_study_id