Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study

Breast Cancer Clinical Trial

Official title:

Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841928
• Other study ID #: MOST Pain Pilot
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• 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 breast cancer treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozole or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation

• Pain corresponding to a min. pain score of >= 3 on pain intensity 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:

• 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

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.
• Value-based 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	Qualitative Interviews	Participants will be invited to participate in a 30-minutes semi-structured individual interview 10-14 days after their last session. The interview serves to support the validation of the treatment components and to provide in-depth knowledge about the participants' experiences through their qualitative comments.	10-14 days after last session
Other	Moderator: Demographic characteristics	Socio-demographic characteristics will be assessed using single questions (e.g., municipality, marital status, income, work status).	Baseline (T1)
Other	Moderator: Clinical characteristics	Clinical characteristics will be assessed using single questions (e.g., date of surgery, adjuvant therapy).	Baseline (T1)
Other	Moderator: Treatment expectancy	Treatment expectancy will be assessed using a single question regarding the extent to which the participant believes that the intervention will 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: Home work	Homework will be assessed with 4 single items related to i) whether home work 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) and 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 1 week after last session (Post-intervention, T2)
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 6 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 subscale of the 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 (2 items from the 11-item subscale of the 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 subscale of the 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 (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 acceptance and activity engagement.	Before each session (Ts)
Other	Mediator: Pain acceptance and 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 acceptance and 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. Higher scores yield 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. Higher scores yield more pain interference.	Baseline (T1) to 1 week after last session (Post-intervention, T2)
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. Higher scores yield more pain.	Every day for 6 days following the first session (Td) for each treatment component
Secondary	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)	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.	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. Higher scores yield more pain burden.	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 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 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 distress.	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 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 1 week after last session (Post-intervention, T2)