Optimizing Psychological Treatment for Pain After Breast Cancer

NCT05444101 | Unknown

• 1 other identifier: MOST Pain
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic; Breast Cancer

Keywords

Breast Cancer; Pain; Contemporary cognitive behavioral 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. A higher score yields 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. A higher score yields more pain.

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

Secondary Outcomes (18)

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

  Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)

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

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

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

  Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)

• 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)

Other Outcomes (17)

• Moderator: Socio-demographic characteristics

  Baseline (T1)

• Moderator: Clinical characteristics

  Baseline (T1)

• Moderator: Treatment expectancy

  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: Values and committed action

Mindful attention + Decentering

EXPERIMENTAL

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).

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 in different orders. Total number of sessions: 4 (4 contact hours).

Behavioral: Mindful attention; Behavioral: Values and committed 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 in different orders. Total number of sessions: 4 (4 contact hours).

Behavioral: Decentering; Behavioral: Values and committed action

Mindful attention + Decentering + Values and committed 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 in different orders. Total number of sessions: 6 (6 contact hours).

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

Values and committed 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 + Values and committed 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Aarhus University

Aarhus, Central Jutland, 8000, Denmark

RECRUITING

Related Publications (1)

• Buskbjerg C, O'Toole MS, Zachariae R, Jensen AB, Frederiksen Y, Johansen C, von Heymann A, Speckens A, Johannsen M. Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark. BMJ Open. 2023 Mar 22;13(3):e066505. doi: 10.1136/bmjopen-2022-066505.

  PMID: 36948567 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

• Robert Zachariae, DMSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilie R Buskbjerg, PhD

CONTACT

+4529842526; cdrc@psy.au.dk

Robert Zachariae, DMSc

CONTACT

+4587165878; bzach@rm.dk

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: Professor

Model Details: The study uses a 2\^3 factorial design, randomizing participants to 8 experimental conditions. The seven active conditions consist of one, two, or three different treatment components. Participants receiving two or three treatment components will be randomized to receive them in different order.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 5, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: Researchers aiming to publish IPD meta-analyses

Locations

DK (1)