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

NCT ID: NCT06982391

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-12
• Study Completion Date: 2026-04-15

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.

Detailed Description

Intervention studies aiming to increase psychological resilience in women with breast cancer after mastectomy are gaining increasing attention in the literature. Various studies highlight the positive effects of social support and psychological flexibility on the mental health of cancer patients. In particular, social support enhances the stress-coping capacity of cancer patients and strengthens their psychological resilience (Hulbert-Williams et al., 2015).

Acceptance and Commitment Therapy (ACT)-based interventions are considered an effective approach for coping with chronic illnesses. Studies on cancer patients emphasize that ACT increases psychological flexibility, helping patients accept challenging emotions and focus on meaningful areas of life (Hayes et al., 2006).

The innovative aspect of this study is the evaluation of both social support and ACT-based flexibility interventions together, examining their combined effects on psychological resilience after breast cancer. Research that comprehensively explores the interaction between social support and psychological flexibility remains limited. This study offers a more effective model for enhancing resilience in cancer patients by assessing the combined impact of components such as social support and psychological flexibility.

In this context, the research contributes significantly to the literature by presenting an integrated approach to increasing psychosocial resilience in the post-breast cancer period and offering a new perspective for intervention studies in this field.

The study includes a total of 20 female participants, aged between 18 and 65, who have undergone mastectomy and voluntarily agree to participate. Participation is voluntary, and participants may withdraw at any time without consequence.

The following scales are used in the study: Sociodemographic and Clinical Information Form, Interpersonal Support Evaluation List-12 (ISEL-12), Self-Compassion Scale-Short Form (SCS-SF), Acceptance and Action Questionnaire-II (AAQ-II), Brief Resilience Scale (BRS), and PROMIS Scales - Global Health Scale, Social Roles and Activities Participation - Short Form 4a, Depression - Short Form 4a, Anxiety - Short Form 4a.

Program Sessions

Session 1: Introduction, Introduction to ReACT Program Purposes, ReACT Matrix, Identifying Values, Defusion

Goal: Introduce the program to participants. They explore their values using the Matrix, identify thoughts that distance them from their values, explore their behaviors, focus to observe their thoughts, practice a present moment awareness exercise, and learn cognitive defusion.

Content:

Psychoeducation: Discuss the importance of psychological resilience, social support, and compassion after breast cancer (Hayes et al., 2006).

Exercise: Participants practice the "Present Moment Exercise" to ground themselves in the here and now with openness and awareness. This practice helps them observe thoughts without becoming entangled in them, supporting more intentional and values-based actions.

Session 2: Acceptance of Anxiety, Compassion, and Action

Goal: Help participants manage difficult emotions and understand how they can move forward while accepting difficult emotions.

Content:

Psychoeducation: Participants explore the questions "What are emotions?" and "What is the function of emotions?" They learn that emotions serve as signals of what matters in life. The idea of making space for emotions instead of fighting them is introduced, along with the insight that this can help reveal underlying values. The link between emotions and values is explored with examples.

Exercise: The sky metaphor is introduced to support acceptance of difficult emotions. If it is not effective, an alternative acceptance exercise is offered.

Session 3: Value-Driven Actions, Sustainability, and Committed Action Toward Receiving and Giving Compassion

Goal: Explore values, value-oriented behaviors, and action planning related to giving and receiving compassion.

Content:

Action Plan: Participants identify daily behaviors that align with their values and develop an action plan (Moreno et al., 2022).

Group Sharing: Participants share their experiences and what they have learned throughout the sessions (Hayes et al., 2006).

Exercise: Participants receive a guide to monitor their progress and maintain value-driven actions (Kabat-Zinn, 1990).

Monitoring and Evaluation

Goal: Evaluate the effects of the intervention and support sustainability.

Content:

Post-Program Evaluation: Final assessments are conducted immediately after the program ends.

Follow-Up: A Zoom group monitoring session is held four weeks later.

Review: During follow-up, changes in psychological resilience, psychological flexibility, compassion, value-based living, and PROMIS scales are reviewed (Neff, 2003; Moreno et al., 2022).

Conditions

Breast Cancer Survivor; Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

This is the intervention arm

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.

Group Type: EXPERIMENTAL

Resilience-Focused Acceptance and Commitment Therapy (ReACT) Program

Intervention Type: 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.

Control Arm

This group will receive standard care

Group Type: EXPERIMENTAL

No intervention

Intervention Type: OTHER

Standard Care

Interventions

Resilience-Focused Acceptance and Commitment Therapy (ReACT) Program

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.

Intervention Type: BEHAVIORAL

No intervention

Standard Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Ela Ari

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ela Arı, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Florence Nightingale Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1357-2481

Identifier Type: -

Identifier Source: org_study_id