Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- Pain intensity (11-point Numeric Rating Scale, NRS)
Study Overview
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:
- 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.
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Mindful attention
Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).
Intervention: Mindful attention (Behavioral)
Decentering
Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours).
Intervention: Decentering (Behavioral)
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).
Intervention: Values and committed action (Behavioral)
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).
Intervention: Mindful attention (Behavioral)
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).
Intervention: Decentering (Behavioral)
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).
Intervention: Mindful attention (Behavioral)
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).
Intervention: Values and committed action (Behavioral)
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).
Intervention: Decentering (Behavioral)
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).
Intervention: Values and committed action (Behavioral)
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).
Intervention: Mindful attention (Behavioral)
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).
Intervention: Decentering (Behavioral)
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).
Intervention: Values and committed action (Behavioral)
Outcomes
Primary Outcomes
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. A higher score yields more pain.
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. A higher score yields more pain.
Secondary Outcomes
- Pain intensity (11-point Numeric Rating Scale, NRS)(Every day for 6 days following the first session (Td) for each treatment component)
- Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain burden (11-point Numeric Rating Scale, NRS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- 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)(Every day for 6 days following the first session (Td) for each treatment component)
- Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain frequency (1 item)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain intensity (11-point Numeric Rating Scale, NRS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain burden (11-point Numeric Rating Scale, NRS)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Pain frequency (1 item)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
Investigators
Bobby Zachariae
Professor
University of Aarhus