Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study

University of Aarhus

Status: Completed

Conditions: Breast Cancer; Pain, Chronic

Treatments: Behavioral: Mindful attention; Behavioral: Value-based action; Behavioral: Decentering

Study type: Interventional

Funder types: Other

Identifiers

NCT04841928

MOST Pain Pilot

Details and patient eligibility

About

The present study is a pilot study that aims to evaluate the feasibility, validity, and preliminary efficacy of three psychological treatment components for pain after breast cancer, which will be evaluated in a larger trial following completion of the present pilot study.

Full description

The present pilot study is a precursor for a following larger trial and aims to evaluate the i) feasibility, ii) validity, and iii) preliminary efficacy of the three treatment components that will be further investigated in a subsequent larger trial. The present pilot study will employ the same design as will be used in the subsequent larger trial, namely the Multiphase Optimization Strategy (MOST). Specifically, in the subsequent larger trial, MOST will be used to evaluate the efficacy and change processes of three psychological treatment components selected from so-called "third wave" cognitive therapies (CTs), which have been shown to be efficacious in the treatment of pain after breast cancer.

The overall hypothesis is that the selected third wave CT components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. Specifically, we hypothesize that:

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 and acting automatically in response to thoughts), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
3. Values and committed action (i.e., behavior linked to values and goals) will increase acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain intensity and -interference.

Enrollment: 31 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 breast cancer treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozole or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation
• Pain corresponding to a min. pain score of >= 3 on pain intensity 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

• Metastatic breast cancer (stage IV)
• Breast cancer recurrence
• Bilateral breast cancer
• Other current cancer disease
• Other current pain condition (e.g., fibromyalgia)
• Current severe psychiatric disorder (e.g., psychosis)
• Inability to communicate in Danish
• Inability 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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31 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: Value-based action

Mindful attention + Decentering

Experimental group

Description:

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

Treatment:

Behavioral: Decentering

Behavioral: Mindful attention

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. Total number of sessions: 4 (4 contact hours).

Treatment:

Behavioral: Mindful attention

Behavioral: Value-based 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. Total number of sessions: 4 (4 contact hours).

Treatment:

Behavioral: Decentering

Behavioral: Value-based action

Mindful attention + Decentering + Value-based 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. Total number of sessions: 6 (6 contact hours).

Treatment:

Behavioral: Decentering

Behavioral: Mindful attention

Behavioral: Value-based action