Optimizing Psychological Treatment for Pain After Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444101
• Other study ID #: MOST Pain
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: Cecilie R Buskbjerg, PhD
• Phone: +4529842526
• Email: cdrc[@]psy.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Pain, Chronic

Intervention

Behavioral:
• Mindful attention
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.
• Decentering
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.
• Values and committed action
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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus	Central Denmark Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Council for Independent Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderator: Socio-demographic characteristics	Socio-demographic characteristics will be assessed using single questions (e.g., marital status, income, work status).	Baseline (T1)
Other	Moderator: Clinical characteristics	Clinical data will be obtained from the register of the national Danish Breast Cancer Group (DCBG), including disease characteristics (e.g., date of diagnosis; endocrine receptor status; menopausal status) and allocated treatment protocol (e.g., type of primary surgery; radiotherapy (yes/no); endocrine therapy (yes/no); Herceptin treatment (yes/no); Zoledronic acid (yes/no)).	Baseline (T1)
Other	Moderator: Treatment expectancy	Treatment expectancy will be assessed using a single question regarding the extent to which the participant expects that the intervention to reduce pain and increase overall well-being. Answer format range: 1 (not at all) to 5 (a great deal); total score range: 1-5. Higher scores indicate stronger expectations that the intervention will lead to a positive outcome.	Baseline (T1)
Other	Moderator: Therapeutic alliance (the 12-item Working Alliance Inventory, WAI) Revised Short Form	The WAI is a validated, self-report instrument assessing therapeutic alliance. Answer format range: 1 (never) to 7 (all the time); total score range: 12-84. Higher scores yield a stronger therapeutic alliance.	1 week after last session (Post-intervention, T2)
Other	Moderator: Homework	Homework will be assessed with 4 single items related to i) whether homework has been conducted (yes/no), and the ii) type, iii) frequency (number of days per week), and iv) duration of completed homework (average number of minutes per day).	Before each session (Ts), 1 week after last session (Post-intervention, T2), and 12 weeks after post-intervention (T2) (follow-up, T3)
Other	Mediator: Mindful attention (the 15-item Mindful Attention Awareness Scale, MAAS)	The MAAS is a validated, self-report instrument assessing individual differences in the frequency of mindful states over time. Answer format range: 1 (almost always) to 6 (almost never); total score range: 1-6. Higher scores yield higher levels of mindful attention.	Baseline (T1) to 1 week after last session (Post-intervention, T2)
Other	Mediator: Mindful attention (the 15-item Mindful Attention Awareness Scale, MAAS)	The MAAS is a validated, self-report instrument assessing individual differences in the frequency of mindful states over time. Answer format range: 1 (almost always) to 6 (almost never); total score range: 1-6. Higher scores yield higher levels of mindful attention.	Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Other	Mediator: Mindful attention (2 items from the 15-item Mindful Attention Awareness Scale, MAAS)	MAAS items 13 and 7 will be assessed before each session (Ts). Answer format range: 1 (almost always) to 6 (almost never). Higher scores yield higher levels of mindful attention.	Before each session (Ts)
Other	Mediator: Mindful attention (1 item from the 15-item Mindful Attention Awareness Scale, MAAS)	MAAS item 7 will be assessed every day for 6 days following the first session (Td) for each treatment component. Answer format range: 1 (almost always) to 6 (almost never). Higher scores yield higher levels of mindful attention.	Every day for 6 days following the first session for each treatment component (Td)
Other	Mediator: Decentering (the 11-item Experiences Questionnaire, EQ)	The EQ is a validated, self-report instrument assessing decentering. Answer format range: 1 (do not agree at all) to 5 (agree completely); total score range: 11-55. Higher scores yield higher levels of decentering.	Baseline (T1) to 1 week after last session (Post-intervention, T2)
Other	Mediator: Decentering (the 11-item Experiences Questionnaire, EQ)	The EQ is a validated, self-report instrument assessing decentering. Answer format range: 1 (do not agree at all) to 5 (agree completely); total score range: 11-55. Higher scores yield higher levels of decentering.	Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Other	Mediator: Decentering (2 items from the 11-item Experiences Questionnaire, EQ)	EQ items 5 and 7 will be assessed before each session (Ts). Answer format range: 1 (do not agree at all) to 5 (agree completely). Higher scores yield higher levels of decentering.	Before each session (Ts)
Other	Mediator: Decentering (1 item from the 11-item Experiences Questionnaire, EQ)	EQ item 5 will be assessed every day for 6 days following the first session (Td) for each treatment component. Answer format range: 1 (do not agree at all) to 5 (agree completely). Higher scores yield higher levels of decentering.	Every day for 6 days following the first session for each treatment component (Td)
Other	Mediator: Pain acceptance and activity engagement (the 20-item Chronic Pain Acceptance Scale, CPAS)	The CPAS is a validated, self-report instrument assessing pain acceptance and activity engagement. Answer format range: 0 (never true) to 6 (always true); subscale score range: 0-54 (pain acceptance subscale), 0-66 (activity engagement subscale). Higher scores yield more acceptance and activity engagement.	Baseline (T1) to 1 week after last session (Post-intervention, T2)
Other	Mediator: Pain acceptance and activity engagement (the 20-item Chronic Pain Acceptance Scale, CPAS)	The CPAS is a validated, self-report instrument assessing pain acceptance and activity engagement. Answer format range: 0 (never true) to 6 (always true); subscale score range: 0-54 (pain acceptance subscale), 0-66 (activity engagement subscale). Higher scores yield more acceptance and activity engagement.	Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Other	Mediator: Activity engagement (2 items from the 20-item Chronic Pain Acceptance Scale, CPAS)	CPAS items 1 and 12 will be assessed before each session (Ts). Answer format range: 0 (never true) to 6 (always true). Higher scores yield more activity engagement.	Before each session (Ts)
Other	Mediator: Activity engagement (1 item from the 20-item Chronic Pain Acceptance Scale, CPAS)	CPAS item 1 will be assessed every day for 6 days following the first session (Td) for each treatment component. Answer format range: 0 (never true) to 6 (always true). Higher scores yield more activity engagement	Every day for 6 days following the first session for each treatment component (Td)
Primary	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)
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)