Compassion, Social Support, Flexibility, and Resilience Program for Women Surviving Breast Cancer

NCT06982391 | Enrolling By Invitation

• 1 other identifier: 1357-2481
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effects of an Acceptance and Commitment Therapy (ACT) based program (ReACT) to increase social support, compassion and psychological flexibility on psychological resilience in women undergoing mastectomy. The main question it aims to answer is: Does the ReACT program improve participants' resilience by increasing social support, compassion, and psychological flexibility? Researchers will compare intervention group to control group to see if ReACT program works to improve participants' resilience. Researchers will randomly divide participants into two groups: intervention group and control group.

• Participants will complete some questionnaires.
• Participants in the intervention group will join a 3-week ACT-based psychological flexibility program. This program consists of sessions that last 90 minutes each. The program adopts the core principles of ACT and aims to help participants develop skills in mindfulness, acceptance, value-driven living, and cognitive defusion.
• Participants will complete the same questionnaires again after the program.
• Participants will complete the same questionnaires again 1 month after the program ends.

Conditions

Breast Cancer Survivor; Mastectomy

Keywords

resilience; psychological flexibility; values; self as compassionate context; social support; value-driven committed action; acceptance; defusion

Outcome Measures

Primary Outcomes (1)

• Resilience

  Psychological resilience will be assessed using the Brief Resilience Scale (BRS). The outcome will measure changes from baseline (pre-intervention) to post-intervention (immediately after the 3-week program). The Brief Resilience Scale evaluates the individual's ability to recover from stress and adversity.

  three weeks

Secondary Outcomes (3)

• Self Compassion

  three weeks

• Psychological Flexibility

  Three weeks

• Well-being

  Three weeks

Study Arms (2)

This is the intervention arm

EXPERIMENTAL

Participants assigned to the intervention arm will take part in the Resilience-Focused Acceptance and Commitment Therapy (ReACT) program. This program includes three weekly 90-minute structured group sessions specifically designed for women who have undergone mastectomy following breast cancer. The intervention integrates core Acceptance and Commitment Therapy (ACT) techniques (acceptance, cognitive defusion, mindfulness, values clarification, committed action) with a focus on psychological resilience and enhancing perceived social support. Participants will also engage in experiential exercises and home practices aimed at improving psychological flexibility, coping skills, and post-cancer adjustment.

Behavioral: Resilience-Focused Acceptance and Commitment Therapy (ReACT) Program

Control Arm

EXPERIMENTAL

This group will receive standard care

Other: No intervention

Interventions

Resilience-Focused Acceptance and Commitment Therapy (ReACT) Program BEHAVIORAL

The Resilience-Focused Acceptance and Commitment Therapy (ReACT) program is a structured, group-based psychological intervention specifically designed for women who have undergone mastectomy following breast cancer. The program consists of three weekly 90-minute sessions integrating core ACT processes, including acceptance, defusion, mindfulness, values clarification, and committed action, with an emphasis on building psychological resilience, self-compassion, and enhancing perceived social support. The program uniquely combines evidence-based ACT techniques with group exercises focused on post-cancer psychosocial adjustment.

This is the intervention arm

No intervention OTHER

Standard Care

Control Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female individuals who have had a mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged between 18 and 65 years.
• Participants who have undergone a mastectomy.
• Participants who voluntarily agree to participate in the study.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Florence Nightingale Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Ela Arı, Assistant Professor

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: An interventional study design for a single group typically involves selecting a group of participants who meet specific inclusion criteria, and then applying an intervention to this group. The participants are assessed before the intervention (pre-test), followed by the application of the intervention, which could be a treatment, educational program, or behavioral change activity. After the intervention, participants are assessed again (post-test) to evaluate any changes in the targeted outcomes. The design includes a follow-up period to assess the sustainability of the effects. The focus of a two arms randomized control design is on examining the impact of the intervention on the group, with comparisons made between pre- and post-intervention measurements and the standard care group.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: April 12, 2025
• Primary Completion: January 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

TU (1)