Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841928
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
Danish Council for Independent Research
Information provided by (Responsible Party):
Maja Johannsen, University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Breast Cancer Behavioral: Mindful attention Behavioral: Decentering Behavioral: Value-based action Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The study uses a 2^3 factorial design, randomizing participants to 8 experimental conditions
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: 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.
Experimental: Mindful attention
Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).
Behavioral: 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.

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

Experimental: 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).
Behavioral: Value-based 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.

Experimental: Mindful attention + Decentering
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
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.

Behavioral: 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.

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

Behavioral: Value-based 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.

Experimental: Decentering + Values and committed action
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
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.

Behavioral: Value-based 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.

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

Behavioral: 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.

Behavioral: Value-based 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.




Primary Outcome Measures :
  1. Pain intensity (11-point Numeric Rating Scale, NRS) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.

  2. Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.


Secondary Outcome Measures :
  1. Pain intensity (11-point Numeric Rating Scale, NRS) [ Time Frame: Every day for 6 days following the first session (Td) for each treatment component ]
    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.

  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) [ Time Frame: Every day for 6 days following the first session (Td) for each treatment component ]
    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.

  3. Pain burden (11-point Numeric Rating Scale, NRS) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.

  4. Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.

  5. Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.

  6. Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.

  7. Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.

  8. Well-being (the 5-item WHO-5 Well-Being Index, WHO-5) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    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.


Other Outcome Measures:
  1. Qualitative Interviews [ Time Frame: 10-14 days after last session ]
    Participants will be invited to participate in a 30-minutes semi-structured individual interview 10-14 days after their last session. The interview serves to support the validation of the treatment components and to provide in-depth knowledge about the participants' experiences through their qualitative comments.

  2. Moderator: Demographic characteristics [ Time Frame: Baseline (T1) ]
    Socio-demographic characteristics will be assessed using single questions (e.g., municipality, marital status, income, work status).

  3. Moderator: Clinical characteristics [ Time Frame: Baseline (T1) ]
    Clinical characteristics will be assessed using single questions (e.g., date of surgery, adjuvant therapy).

  4. Moderator: Treatment expectancy [ Time Frame: Baseline (T1) ]
    Treatment expectancy will be assessed using a single question regarding the extent to which the participant believes that the intervention will reduce pain and increase overall well-being. Answer format range: 1 (not at all) to 5 (a great deal); total score range: 1-5. Higher scores indicate stronger expectations that the intervention will lead to a positive outcome.

  5. Moderator: Therapeutic alliance (the 12-item Working Alliance Inventory, WAI) Revised Short Form [ Time Frame: 1 week after last session (Post-intervention, T2) ]
    The WAI is a validated, self-report instrument assessing therapeutic alliance. Answer format range: 1 (never) to 7 (all the time); total score range: 12-84. Higher scores yield a stronger therapeutic alliance.

  6. Moderator: Home work [ Time Frame: Before each session (Ts) and 1 week after last session (Post-intervention, T2) ]
    Homework will be assessed with 4 single items related to i) whether home work has been conducted (yes/no), and the ii) type, iii) frequency (number of days per week), and iv) duration of completed homework (average number of minutes per day).

  7. Mediator: Mindful attention (the 15-item Mindful Attention Awareness Scale, MAAS) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    The MAAS is a validated, self-report instrument assessing individual differences in the frequency of mindful states over time. Answer format range: 1 (almost always) to 6 (almost never); total score range: 1-6. Higher scores yield higher levels of mindful attention.

  8. Mediator: Mindful attention (2 items from the 15-item Mindful Attention Awareness Scale, MAAS) [ Time Frame: Before each session (Ts) ]
    MAAS items 13 and 7 will be assessed before each session (Ts). Answer format range: 1 (almost always) to 6 (almost never). Higher scores yield higher levels of mindful attention.

  9. Mediator: Mindful attention (1 item from the 15-item Mindful Attention Awareness Scale, MAAS) [ Time Frame: Every day for 6 days following the first session for each treatment component (Td) ]
    MAAS item 6 will be assessed every day for 6 days following the first session (Td) for each treatment component. Answer format range: 1 (almost always) to 6 (almost never). Higher scores yield higher levels of mindful attention.

  10. Mediator: Decentering (the 11-item subscale of the Experiences Questionnaire, EQ) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    The EQ is a validated, self-report instrument assessing decentering. Answer format range: 1 (do not agree at all) to 5 (agree completely); total score range: 11-55. Higher scores yield higher levels of decentering.

  11. Mediator: Decentering (2 items from the 11-item subscale of the Experiences Questionnaire, EQ) [ Time Frame: Before each session (Ts) ]
    EQ items 5 and 7 will be assessed before each session (Ts). Answer format range: 1 (do not agree at all) to 5 (agree completely). Higher scores yield higher levels of decentering.

  12. Mediator: Decentering (1 item from the 11-item subscale of the Experiences Questionnaire, EQ) [ Time Frame: Every day for 6 days following the first session for each treatment component (Td) ]
    EQ item 5 will be assessed every day for 6 days following the first session (Td) for each treatment component. Answer format range: 1 (do not agree at all) to 5 (agree completely). Higher scores yield higher levels of decentering.

  13. Mediator: Pain acceptance and activity engagement (the 20-item Chronic Pain Acceptance Scale, CPAS) [ Time Frame: Baseline (T1) to 1 week after last session (Post-intervention, T2) ]
    The CPAS is a validated, self-report instrument assessing pain acceptance and activity engagement. Answer format range: 0 (never true) to 6 (always true); subscale score range: 0-54 (pain acceptance subscale), 0-66 (activity engagement subscale). Higher scores yield more acceptance and activity engagement.

  14. Mediator: Pain acceptance and activity engagement (2 items from the 20-item Chronic Pain Acceptance Scale, CPAS) [ Time Frame: Before each session (Ts) ]
    CPAS items 1 and 12 will be assessed before each session (Ts). Answer format range: 0 (never true) to 6 (always true). Higher scores yield more acceptance and activity engagement.

  15. Mediator: Pain acceptance and activity engagement (1 item from the 20-item Chronic Pain Acceptance Scale, CPAS) [ Time Frame: Every day for 6 days following the first session for each treatment component (Td) ]
    CPAS item 1 will be assessed every day for 6 days following the first session (Td) for each treatment component. Answer format range: 0 (never true) to 6 (always true). Higher scores yield more acceptance and activity engagement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841928


Contacts
Layout table for location contacts
Contact: Cecilie R Buskbjerg, PhD +4560202628 cdrc@psy.au.dk
Contact: Maja Johannsen, PhD +4587165956 majajo@psy.au.dk

Locations
Layout table for location information
Denmark
Aarhus University Recruiting
Aarhus, Central Denmark Region, Denmark, 8000
Contact: Cecilie R Buskbjerg, PhD    +4560202628    cdrc@psy.au.dk   
Sponsors and Collaborators
University of Aarhus
Danish Council for Independent Research
Investigators
Layout table for investigator information
Principal Investigator: Maja Johannsen, PhD University of Aarhus
Layout table for additonal information
Responsible Party: Maja Johannsen, Assistant Professor, University of Aarhus
ClinicalTrials.gov Identifier: NCT04841928    
Other Study ID Numbers: MOST Pain Pilot
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Maja Johannsen, University of Aarhus:
Breast cancer
Pain
Third wave cognitive therapy
Mindful attention
Decentering
Values and committed action
The Multiphase Optimization Strategy (MOST)
Psychological pain treatment
Treatment mediators
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Chronic Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations