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Pain, ChronicNCT04841928

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

A study testing Mindful attention, Decentering and Value-based action in people with Pain, Chronic and Breast Cancer, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Pain, Chronic, Breast Cancer
What is being tested?
Mindful attention, Decentering and Value-based action
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteDenmark
Study dates
1 Mar 2021to 1 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University

    Aarhus, Central Jutland, 8000

Other trials in Denmark

About this study

Official title: Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study

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.

Read the detailed 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.
Being tested
Mindful attention, Decentering, Value-based action
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
Medical subject headings
Chronic Pain, Breast Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful attentionBehavioural

    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.

  • DecenteringBehavioural

    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.

  • Value-based actionBehavioural

    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.

Study groups in NCT04841928
Study groupRoleWhat they receive
Waitlist controlNo interventionParticipants 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 attentionExperimentalParticipants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).
Receives: Behavioral: Mindful attention
DecenteringExperimentalParticipants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours).
Receives: Behavioral: Decentering
Values and committed actionExperimentalParticipants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours).
Receives: Behavioral: Value-based action
Mindful attention + DecenteringExperimentalParticipants randomized to condition 5 will receive the Mindful attention treatment component and the Decentering treatment component. Total number of sessions: 4 (4 contact hours).
Receives: Behavioral: Mindful attention; Behavioral: Decentering
Mindful attention + Values and committed actionExperimentalParticipants 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).
Receives: Behavioral: Mindful attention; Behavioral: Value-based action
Decentering + Values and committed actionExperimentalParticipants 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).
Receives: Behavioral: Decentering; Behavioral: Value-based action
Mindful attention + Decentering + Value-based actionExperimentalParticipants 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).
Receives: Behavioral: Mindful attention; Behavioral: Decentering; Behavioral: Value-based action

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (8)

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

    Pain intensity during the last 24 hours will be assessed every day for 6 days following the first session (Td) for each treatment component using the NRS. Answer format range: 0 (no pain) to 10 (worst possible pain); total score range: 0-10. Higher scores yield more pain.

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

  2. 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)

    Pain interference during the last 24 hours will be assessed every day for 6 days following the first session (Td) for each treatment component using 1 aggregated item assessing pain interference across the 7 domains measured with the BPI interference subscale, 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.

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

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

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

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

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

    The pain descriptors from the MPQ constitutes a validated, self-report instrument assessing pain quality (i.e., pain type, namely continuous pain, intermittent pain, neuropathic pain, affective pain) during the last week. Answer format range: 0 (no pain) to 10 (worst possible pain); total score range: 0-60 (continuous, neuropathic and intermittent pain), 0-40 (affective pain). Higher scores yield more pain.

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

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

    The PCS is a validated, self-report instrument assessing pain catastrophizing. Answer format range: 0 (not at all) to 4 (all the time); total score range: 0-52. Higher scores yield more pain catastrophizing.

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

  6. Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)

    The HADS is a validated, self-report instrument assessing psychological distress during the last week. Answer format range: 0 (not at all or never) to 3 (most or all of the time); total score range 0-42. Higher scores yield more distress.

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

  7. Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)

    The FCRI is a validated, self-report instrument assessing fear of cancer recurrence during the last month. Answer format range: 0 (not at all) to 4 (a great deal); total score range 0-36. Higher scores yield more fear of cancer recurrence.

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

  8. Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)

    The WHO-5 is a validated, self-report instrument assessing current well-being. Answer format range: 0 (at no time) to 5 (all the time); total score range: 0-100. Higher scores yield more well-being.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Jul 2021
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
The study uses a 2\^3 factorial design, randomizing participants to 8 experimental conditions
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04841928
Sponsor's protocol ID
MOST Pain Pilot
Status last verified
Sep 2021
First submitted
23 Mar 2021
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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. 2026 Jun;67(3):771-786. doi: 10.1111/sjop.70063. Epub 2025 Dec 31.

    PubMed 41474052

Questions about this trial

What is this clinical trial studying?

A study testing Mindful attention, Decentering and Value-based action in people with Pain, Chronic and Breast Cancer, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (11-point Numeric Rating Scale, NRS) (time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04841928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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