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

NCT04841928 | Completed

• 1 other identifier: MOST Pain Pilot
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic; Breast Cancer

Keywords

Breast cancer; Pain; Third wave cognitive therapy; Mindful attention; Decentering; Values and committed action; The Multiphase Optimization Strategy (MOST); Psychological pain treatment; Treatment mediators

Outcome Measures

Primary Outcomes (2)

• Pain intensity (11-point Numeric Rating Scale, NRS)

  The NRS is a validated, self-report instrument assessing pain intensity during the last week. Answer format range: 0 (no pain) to 10 (worst possible pain); total score range: 0-10. Higher scores yield more pain.

  Baseline (T1) to 1 week after last session (Post-intervention, T2)

• Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)

  The BPI is a validated, self-report instrument assessing clinical pain. The BPI pain interference subscale assesses pain interference during the last week across 7 domains, i.e., general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Answer format range: 0 (no interference) to 10 (maximal interference); total score range: 0-10. Higher scores yield more pain interference.

  Baseline (T1) to 1 week after last session (Post-intervention, T2)

Secondary Outcomes (8)

• Pain intensity (11-point Numeric Rating Scale, NRS)

  Every day for 6 days following the first session (Td) for each treatment component

• 4. Pain interference (1 aggregated item assessing pain interference during the last 24 hours within the 7 domains measured with the Brief Pain Inventory, BPI, interference subscale)

  Every day for 6 days following the first session (Td) for each treatment component

• Pain burden (11-point Numeric Rating Scale, NRS)

  Baseline (T1) to 1 week after last session (Post-intervention, T2)

• Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)

  Baseline (T1) to 1 week after last session (Post-intervention, T2)

• Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)

  Baseline (T1) to 1 week after last session (Post-intervention, T2)

Other Outcomes (15)

• Qualitative Interviews

  10-14 days after last session

• Moderator: Demographic characteristics

  Baseline (T1)

• Moderator: Clinical characteristics

  Baseline (T1)

Study Arms (8)

Waitlist control

NO INTERVENTION

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

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

Behavioral: Mindful attention

Decentering

EXPERIMENTAL

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

Behavioral: Decentering

Values and committed action

EXPERIMENTAL

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

Behavioral: Value-based action

Mindful attention + Decentering

EXPERIMENTAL

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).

Behavioral: Mindful attention; Behavioral: Decentering

Mindful attention + Values and committed action

EXPERIMENTAL

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).

Behavioral: Mindful attention; Behavioral: Value-based action

Decentering + Values and committed action

EXPERIMENTAL

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).

Behavioral: Decentering; Behavioral: Value-based action

Mindful attention + Decentering + Value-based action

EXPERIMENTAL

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).

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

Interventions

Mindful attention BEHAVIORAL

The Mindful attention treatment component consists of a breathing exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.

Mindful attention; Mindful attention + Decentering; Mindful attention + Decentering + Value-based action; Mindful attention + Values and committed action

Decentering BEHAVIORAL

The Decentering treatment component consists of a guided imagery exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.

Decentering; Decentering + Values and committed action; Mindful attention + Decentering; Mindful attention + Decentering + Value-based action

Value-based action BEHAVIORAL

The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.

Decentering + Values and committed action; Mindful attention + Decentering + Value-based action; Mindful attention + Values and committed action; Values and committed action

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Council for Independent Research: collaborator

Study Sites (1)

Aarhus University

Aarhus, Central Jutland, 8000, Denmark

Location

Related Publications (1)

• Buskbjerg CR, Johannsen M, Norskov CC, Jensen AB, Frederiksen Y, Egerod I, Guastaferro K, Johansen C, von Heymann A, Speckens A, O'Toole MS, Zachariae R. Optimizing Psychological Treatment for Pain After Breast Cancer Using a Randomized Factorial Design: A Feasibility Study. Scand J Psychol. 2025 Dec 31. doi: 10.1111/sjop.70063. Online ahead of print.

  PMID: 41474052 DERIVED

MeSH Terms

Conditions

Chronic Pain; Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maja Johannsen, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study uses a 2\^3 factorial design, randomizing participants to 8 experimental conditions

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 12, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

DK (1)