Optimizing Psychological Treatment for Pain After Breast Cancer

University of Aarhus

Status: Enrolling

Conditions: Breast Cancer; Pain, Chronic

Treatments: Behavioral: Decentering; Behavioral: Mindful attention; Behavioral: Values and committed action

Study type: Interventional

Funder types: Other

Identifiers

NCT05444101

MOST Pain

Details and patient eligibility

About

The present study aims to optimize psychological treatment for pain after breast cancer by identifying active treatment components. Specifically, a factorial design will be used to evaluate the efficacy and change processes of three psychological treatment components, which have been shown to be efficacious in the treatment of pain after breast cancer.

Full description

There is a need for optimization of psychological treatment of pain after breast cancer. Optimization relies on knowledge about the active components of existing treatments. Guided by the Multiphase Optimization Strategy (MOST), the present study aims to address this challenge by identifying active contemporary cognitive behavioral therapy components for breast cancer-related pain. Consistent with the Optimization phase of the MOST framework, a full factorial design will be used to evaluate the efficacy and change processes of three selected treatment components.The overall hypothesis is that the three components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. The treatment components and their hypothesized mechanisms of action are as follows:

1. Mindful attention practices will increase attentional control (i.e., the ability to intentionally focus and intentionally shift one's attention), thereby reducing pain hypervigilance, leading to reductions in pain intensity and -interference.
2. Decentering practices will reduce fusion with thoughts (i.e., getting caught up in one's thoughts, feelings and inner experiences), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
3. Values and committed action (i.e., behavior congruent with one's values) will increase acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain intensity and -interference.

Enrollment: 185 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary breast cancer stage I-III
• Min. 6 months post primary treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozol or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation
• Pain corresponding to a pain score of >= 3 on pain intensity and/or pain interference measured by 11-point Numeric Rating Scales (NRSs)
• Sufficient ability to communicate in Danish
• Sufficient ability to participate in an online-delivered intervention

Exclusion criteria

• Non-curable breast cancer (stage IV)
• Breast cancer recurrence
• Bilateral breast cancer
• Other current cancer disease
• Other primary pain condition (e.g., fibromyalgia)
• Current severe psychiatric disorder (e.g., psychosis) hindering study participation
• Insufficient ability to communicate in Danish
• Insufficient ability to participate in an online-delivered intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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185 participants in 8 patient groups

Waitlist control

No Intervention group

Description:

Participants randomized to condition 1 are not offered any treatment components immediately upon enrollment, but will be offered a treatment component of own choice at the end of the study. Total number of sessions: 2 (2 contact hours) following study completion.

Mindful attention

Experimental group

Description:

Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).

Treatment:

Behavioral: Mindful attention

Decentering

Experimental group

Description:

Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours).

Treatment:

Behavioral: Decentering

Values and committed action

Experimental group

Description:

Participants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours).

Treatment:

Behavioral: Values and committed action

Mindful attention + Decentering

Experimental group

Description:

Participants randomized to condition 5 will receive the Mindful attention treatment component and the Decentering treatment component in different orders. Total number of sessions: 4 (4 contact hours).

Treatment:

Behavioral: Mindful attention

Behavioral: Decentering

Mindful attention + Values and committed action

Experimental group

Description:

Participants randomized to condition 6 will receive the Mindful attention treatment component and the Values and committed action treatment component in different orders. Total number of sessions: 4 (4 contact hours).

Treatment:

Behavioral: Mindful attention

Behavioral: Values and committed action

Decentering + Values and committed action

Experimental group

Description:

Participants randomized to condition 7 will receive the Decentering treatment component and the Values and committed action treatment component in different orders. Total number of sessions: 4 (4 contact hours).

Treatment:

Behavioral: Values and committed action

Behavioral: Decentering

Mindful attention + Decentering + Values and committed action

Experimental group

Description:

Participants randomized to condition 8 will receive the Mindful attention treatment component, the Decentering treatment component, and the Values and committed action treatment component in different orders. Total number of sessions: 6 (6 contact hours).

Treatment:

Behavioral: Mindful attention

Behavioral: Values and committed action

Behavioral: Decentering