Optimizing Psychological Treatment for Pain After Breast Cancer
NCT ID: NCT05444101
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
185 participants
INTERVENTIONAL
2022-09-01
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Waitlist control
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.
No interventions assigned to this group
Mindful attention
Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).
Mindful attention
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.
Decentering
Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours).
Decentering
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.
Values and committed action
Participants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours).
Values and committed action
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.
Mindful attention + Decentering
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).
Mindful attention
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.
Decentering
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.
Mindful attention + Values and committed action
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).
Mindful attention
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.
Values and committed action
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
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).
Decentering
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.
Values and committed action
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.
Mindful attention + Decentering + Values and committed action
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).
Mindful attention
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.
Decentering
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.
Values and committed action
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.
Interventions
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Mindful attention
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.
Decentering
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.
Values and committed action
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Danish Council for Independent Research
OTHER
University of Aarhus
OTHER
Responsible Party
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Bobby Zachariae
Professor
Principal Investigators
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Robert Zachariae, DMSc
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University
Aarhus, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MOST Pain
Identifier Type: -
Identifier Source: org_study_id
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