Clinical trial NCT05444101: Optimizing Psychological Treatment for Pain After Breast Cancer
Official title: Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Council for Independent Research
First posted: 2022-07-05
Enrollment: 185
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. 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.
Primary purpose: TREATMENT

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.

Detailed description: There is a need for optimization of psychological treatment of pain after breast cancer. Optimization relies on knowledge about the active components of existing treatments. Guided by the Multiphase Optimization Strategy (MOST), the present study aims to address this challenge by identifying active contemporary cognitive behavioral therapy components for breast cancer-related pain. Consistent with the Optimization phase of the MOST framework, a full factorial design will be used to evaluate the efficacy and change processes of three selected treatment components.The overall hypothesis is that the three components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. The treatment components and their hypothesized mechanisms of action are as follows:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
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: Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
measure: 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 burden (11-point Numeric Rating Scale, NRS)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
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 quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
measure: Pain frequency (1 item)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Pain frequency (1 item)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
measure: Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)
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 12 weeks after post-intervention (T2) (Follow-up, T3)
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: Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
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: Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
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)
measure: Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Other outcomes:
measure: Moderator: Socio-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: Homework
timeFrame: Before each session (Ts), 1 week after last session (Post-intervention, T2), and 12 weeks after post-intervention (T2) (follow-up, T3)
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 (the 15-item Mindful Attention Awareness Scale, MAAS)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
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 Experiences Questionnaire, EQ)
timeFrame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
measure: Mediator: Decentering (the 11-item Experiences Questionnaire, EQ)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
measure: Mediator: Decentering (2 items from the 11-item Experiences Questionnaire, EQ)
timeFrame: Before each session (Ts)
measure: Mediator: Decentering (1 item from the 11-item 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 (the 20-item Chronic Pain Acceptance Scale, CPAS)
timeFrame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
measure: Mediator: Activity engagement (2 items from the 20-item Chronic Pain Acceptance Scale, CPAS)
timeFrame: Before each session (Ts)
measure: Mediator: 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: Robert Zachariae, DMSc
role: PRINCIPAL_INVESTIGATOR
References: