Optimizing Psychological Treatment for Pain After Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study

Conditions
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Breast Cancer, Pain, Chronic

Intervention / Treatment
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* Behavioral: Mindful attention
* Behavioral: Decentering
* Behavioral: Values and committed action


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist control<br>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. | |
| Experimental: Mindful attention<br>Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours). | Behavioral: Mindful attention<br>* 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.<br>|
| Experimental: Decentering<br>Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours). | Behavioral: Decentering<br>* 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.<br>|
| Experimental: Values and committed action<br>Participants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours). | Behavioral: Values and committed action<br>* 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.<br>|
| Experimental: Mindful attention + Decentering<br>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). | Behavioral: Mindful attention<br>* 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.<br>Behavioral: Decentering<br>* 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.<br>|
| Experimental: Mindful attention + Values and committed action<br>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). | Behavioral: Mindful attention<br>* 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.<br>Behavioral: Values and committed action<br>* 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.<br>|
| Experimental: Decentering + Values and committed action<br>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). | Behavioral: Decentering<br>* 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.<br>Behavioral: Values and committed action<br>* 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.<br>|
| Experimental: Mindful attention + Decentering + Values and committed action<br>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). | Behavioral: Mindful attention<br>* 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.<br>Behavioral: Decentering<br>* 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.<br>Behavioral: Values and committed action<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (T1) to 1 week after last session (Post-intervention, T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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.. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Pain, Contemporary cognitive behavioral therapy, Mindful attention, Decentering, Values and committed action, The Multiphase Optimization Strategy (MOST), Psychological pain treatment, Treatment mediators