Clinical trial NCT04841928: Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study
Official title: Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Council for Independent Research
First posted: 2021-04-12
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study uses a 2\^3 factorial design, randomizing participants to 8 experimental conditions
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain intensity (11-point Numeric Rating Scale, NRS)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Secondary outcomes:
measure: Pain intensity (11-point Numeric Rating Scale, NRS)
timeFrame: Every day for 6 days following the first session (Td) for each treatment component
measure: 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)
timeFrame: Every day for 6 days following the first session (Td) for each treatment component
measure: Pain burden (11-point Numeric Rating Scale, NRS)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Other outcomes:
measure: Qualitative Interviews
timeFrame: 10-14 days after last session
measure: Moderator: Demographic characteristics
timeFrame: Baseline (T1)
measure: Moderator: Clinical characteristics
timeFrame: Baseline (T1)
measure: Moderator: Treatment expectancy
timeFrame: Baseline (T1)
measure: Moderator: Therapeutic alliance (the 12-item Working Alliance Inventory, WAI) Revised Short Form
timeFrame: 1 week after last session (Post-intervention, T2)
measure: Moderator: Home work
timeFrame: Before each session (Ts) and 1 week after last session (Post-intervention, T2)
measure: Mediator: Mindful attention (the 15-item Mindful Attention Awareness Scale, MAAS)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Mediator: Mindful attention (2 items from the 15-item Mindful Attention Awareness Scale, MAAS)
timeFrame: Before each session (Ts)
measure: Mediator: Mindful attention (1 item from the 15-item Mindful Attention Awareness Scale, MAAS)
timeFrame: Every day for 6 days following the first session for each treatment component (Td)
measure: Mediator: Decentering (the 11-item subscale of the Experiences Questionnaire, EQ)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Mediator: Decentering (2 items from the 11-item subscale of the Experiences Questionnaire, EQ)
timeFrame: Before each session (Ts)
measure: Mediator: Decentering (1 item from the 11-item subscale of the Experiences Questionnaire, EQ)
timeFrame: Every day for 6 days following the first session for each treatment component (Td)
measure: Mediator: Pain acceptance and activity engagement (the 20-item Chronic Pain Acceptance Scale, CPAS)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Mediator: Pain acceptance and activity engagement (2 items from the 20-item Chronic Pain Acceptance Scale, CPAS)
timeFrame: Before each session (Ts)
measure: Mediator: Pain acceptance and activity engagement (1 item from the 20-item Chronic Pain Acceptance Scale, CPAS)
timeFrame: Every day for 6 days following the first session for each treatment component (Td)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
state: Central Denmark Region
Study officials:
affiliation: University of Aarhus
name: Maja Johannsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: