Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study
- Conditions
- Pain, ChronicBreast Cancer
- Interventions
- Behavioral: Value-based actionBehavioral: Mindful attentionBehavioral: Decentering
- Registration Number
- NCT04841928
- Lead Sponsor
- University of Aarhus
- Brief Summary
The present study is a pilot study that aims to evaluate the feasibility, validity, and preliminary efficacy of three psychological treatment components for pain after breast cancer, which will be evaluated in a larger trial following completion of the present pilot study.
- Detailed Description
The present pilot study is a precursor for a following larger trial and aims to evaluate the i) feasibility, ii) validity, and iii) preliminary efficacy of the three treatment components that will be further investigated in a subsequent larger trial. The present pilot study will employ the same design as will be used in the subsequent larger trial, namely the Multiphase Optimization Strategy (MOST). Specifically, in the subsequent larger trial, MOST will be used to evaluate the efficacy and change processes of three psychological treatment components selected from so-called "third wave" cognitive therapies (CTs), which have been shown to be efficacious in the treatment of pain after breast cancer.
The overall hypothesis is that the selected third wave CT components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. Specifically, we hypothesize that:
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 and acting automatically in response to thoughts), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
3. Values and committed action (i.e., behavior linked to values and goals) will increase acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain intensity and -interference.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 31
Not provided
- Metastatic breast cancer (stage IV)
- Breast cancer recurrence
- Bilateral breast cancer
- Other current cancer disease
- Other current pain condition (e.g., fibromyalgia)
- Current severe psychiatric disorder (e.g., psychosis)
- Inability to communicate in Danish
- Inability to participate in an online-delivered intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Values and committed action Value-based 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 + Values and committed action Value-based action Participants randomized to condition 6 will receive the Mindful attention treatment component and the Values and committed action treatment component. 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). Mindful attention + Decentering Decentering Participants randomized to condition 5 will receive the Mindful attention treatment component and the Decentering treatment component. Total number of sessions: 4 (4 contact hours). Decentering Decentering Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours). Mindful attention + Decentering Mindful attention Participants randomized to condition 5 will receive the Mindful attention treatment component and the Decentering treatment component. Total number of sessions: 4 (4 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. 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. Total number of sessions: 4 (4 contact hours). Decentering + Values and committed action Value-based action Participants randomized to condition 7 will receive the Decentering treatment component and the Values and committed action treatment component. Total number of sessions: 4 (4 contact hours). Mindful attention + Decentering + Value-based 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. Total number of sessions: 6 (6 contact hours). Mindful attention + Decentering + Value-based action Value-based 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. Total number of sessions: 6 (6 contact hours). Mindful attention + Decentering + Value-based 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. 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. Higher scores yield 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. Higher scores yield more pain interference.
- Secondary Outcome Measures
Name Time Method 4. 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. Higher scores yield more pain interference.
Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ) Baseline (T1) to 1 week after last session (Post-intervention, T2) 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.
Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS) Baseline (T1) to 1 week after last session (Post-intervention, T2) 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 distress.
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. Higher scores yield more pain.
Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS) Baseline (T1) to 1 week after last session (Post-intervention, T2) 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.
Pain burden (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 burden during the last week. Answer format range: 0 (no burden) to 10 (maximal burden); total score range: 0-10. Higher scores yield more pain burden.
Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI) Baseline (T1) to 1 week after last session (Post-intervention, T2) 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.
Well-being (the 5-item WHO-5 Well-Being Index, WHO-5) Baseline (T1) to 1 week after last session (Post-intervention, T2) 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.
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus, Central Denmark Region, Denmark