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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
185
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.
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.
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.
Aarhus University
Aarhus, Central Jutland, Denmark
RECRUITINGPain intensity (11-point Numeric Rating Scale, NRS)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain intensity (11-point Numeric Rating Scale, NRS)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain intensity (11-point Numeric Rating Scale, NRS)
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.
Time frame: 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)
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.
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Time frame: 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)
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..
Time frame: Every day for 6 days following the first session (Td) for each treatment component
Pain burden (11-point Numeric Rating Scale, NRS)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain burden (11-point Numeric Rating Scale, NRS)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain frequency (1 item)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain frequency (1 item)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)
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.
Time frame: 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)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)
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.
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)
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.
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)