Optimizing Psychological Treatment for Pain After Breast Cancer
- Conditions
- Pain, ChronicBreast Cancer
- Interventions
- Behavioral: DecenteringBehavioral: Mindful attentionBehavioral: Values and committed action
- Registration Number
- NCT05444101
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 185
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Decentering Decentering Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours). Mindful attention + Values and committed action Mindful attention 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). Mindful attention + Decentering + Values and committed action 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). Mindful attention + Decentering Mindful attention 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). Decentering + Values and committed action Decentering 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). Decentering + Values and committed action 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). Mindful attention Mindful attention Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours). Values and committed action 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). Mindful attention + Decentering 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). Mindful attention + Values and committed action 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). Mindful attention + Decentering + Values and committed action Mindful attention 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). Mindful attention + Decentering + Values and committed action Decentering 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).
- Primary Outcome Measures
Name Time Method Pain intensity (11-point Numeric Rating Scale, NRS) 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) 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 Outcome Measures
Name Time Method Pain intensity (11-point Numeric Rating Scale, NRS) 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. A higher score yields more pain.
Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI) Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) 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.
Pain burden (11-point Numeric Rating Scale, NRS) Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) 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. A higher score yields more pain burden.
Well-being (the 5-item WHO-5 Well-Being Index, WHO-5) Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) 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.
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 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. A higher score yields more pain..
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) 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.
Pain frequency (1 item) Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) Pain frequency will be assessed using a single question. Answer format range: 1 (never) to 5 (all the time); total score range: 1-5. Higher scores yield higher pain frequency.
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) 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.
Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS) Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) 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.
Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS) Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) 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 psychological distress.
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus, Central Denmark Region, Denmark