An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain

Summary

As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer. Outcomes will include quality of life, physical pain intensity and interference, depression, and anxiety in women with breast cancer. These will be assessed at post-treatment and at the 1-month, 3-month, 6-month and 1 year follow-ups (for Marianna Zacharia's PhD thesis, results will be presented until the 3-month follow-up). Also, the Acceptability and Feasibility of the intervention will be assessed. That is, participants' treatment acceptability and adherence to the brief ACT intervention in terms of retention, treatment engagement and satisfaction with each session and with the overall treatment will be assessed. Participants' reasons for dropout will be recorded.

Conditions

• Female Breast Cancer
• Depression
• Pain

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy

The ACT-based intervention will be delivered in a group format. Due to the COVID-19 pandemic and given that breast cancer patients are considered a vulnerable population, the intervention will be administered online through a GDPR compliant platform. The six, weekly, 90-minute treatment sessions (total of 9 hours) will be conducted in groups of approximately 8-10 participants and one therapist.

OTHER

Waitlist Control Group

Participants randomized to the WL condition will be asked to continue receiving the services they receive from anti-cancer associations (receiving care from nurses, or/and support from social workers, or/and physiotherapy or/and individual psychological support from licensed psychologists just like the women in the experimental condition).

Sponsors & Collaborators

• University of Cyprus

  lead OTHER

Principal Investigators

• Maria Karekla, Ph.D. · ACThealthy Lab, University of Cyprus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-20

Primary Completion

2025-05-30

Completion

2025-06-30

Countries

• Cyprus

Study Locations