Pain, ChronicNCT05444101
Optimizing Psychological Treatment for Pain After Breast Cancer
A study testing Mindful attention, Decentering and Values and committed action in people with Pain, Chronic and Breast Cancer, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain, Chronic, Breast Cancer
- What is being tested?
- Mindful attention, Decentering and Values and committed action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University
Aarhus, Central Jutland, 8000
Cecilie R Buskbjerg, PhD, +4529842526, cdrc@psy.au.dk
About this study
Official title: Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study
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.
Read the detailed 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:
- 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.
- Conditions
- Pain, Chronic, Breast Cancer
- Being tested
- Mindful attention, Decentering, Values and committed action
- Keywords
- Breast Cancer, Pain, Contemporary cognitive behavioral therapy, Mindful attention, Decentering, Values and committed action, The Multiphase Optimization Strategy (MOST), Psychological pain treatment, Treatment mediators
- Medical subject headings
- Chronic Pain, Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful attentionBehavioural
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.
DecenteringBehavioural
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 actionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control | No intervention | 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. |
| Mindful attention | Experimental | Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours). Receives: Behavioral: Mindful attention |
| Decentering | Experimental | Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours). Receives: Behavioral: Decentering |
| Values and committed action | Experimental | Participants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours). Receives: Behavioral: Values and committed action |
| Mindful attention + Decentering | Experimental | 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). Receives: Behavioral: Mindful attention; Behavioral: Decentering |
| Mindful attention + Values and committed action | Experimental | 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). Receives: Behavioral: Mindful attention; Behavioral: Values and committed action |
| Decentering + Values and committed action | Experimental | 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). Receives: Behavioral: Decentering; Behavioral: Values and committed action |
| Mindful attention + Decentering + Values and committed action | Experimental | 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). Receives: Behavioral: Mindful attention; Behavioral: Decentering; Behavioral: Values and committed action |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Sep 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Council for Independent Research
- Responsible party
- Principal investigator, Bobby Zachariae, University of Aarhus
- Investigators
- Robert Zachariae, DMSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444101
- Sponsor's protocol ID
- MOST Pain
- Status last verified
- Nov 2022
- First submitted
- 27 Jun 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.
Publications
Buskbjerg C, O'Toole MS, Zachariae R, Jensen AB, Frederiksen Y, Johansen C, von Heymann A, Speckens A, Johannsen M. Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark. BMJ Open. 2023 Mar 22;13(3):e066505. doi: 10.1136/bmjopen-2022-066505.
PubMed 36948567
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study
- ClinicalTrials.gov ID
- NCT05444101
- Acronym / sponsor ID
- MOST Pain
- Conditions
- Pain, Chronic, Breast Cancer
- Keywords
- Breast Cancer, Pain, Contemporary cognitive behavioral therapy, Mindful attention, Decentering, Values and committed action, The Multiphase Optimization Strategy (MOST), Psychological pain treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Council for Independent Research
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | No intervention | –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. |
| Mindful attention | Experimental | Behavioral: Mindful attentionParticipants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours). |
| Decentering | Experimental | Behavioral: DecenteringParticipants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours). |
| Values and committed action | Experimental | Behavioral: Values and committed actionParticipants randomized to condition 4 will receive the Values and committed action treatment component. Total number of sessions: 2 (2 contact hours). |
| Mindful attention + Decentering | Experimental | Behavioral: Mindful attention, Behavioral: DecenteringParticipants 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). |
| Mindful attention + Values and committed action | Experimental | Behavioral: Mindful attention, Behavioral: Values and committed actionParticipants 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). |
| Decentering + Values and committed action | Experimental | Behavioral: Decentering, Behavioral: Values and committed actionParticipants 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). |
| Mindful attention + Decentering + Values and committed action | Experimental | Behavioral: Mindful attention, Behavioral: Decentering, Behavioral: Values and committed actionParticipants 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Non-curable breast cancer (stage IV)
- Breast cancer recurrence
- Bilateral breast cancer
- Other current cancer disease
- Other primary pain condition (e.g., fibromyalgia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful attentionThe 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. | Behavioural | Mindful attention, Mindful attention + Decentering, Mindful attention + Decentering + Values and committed action, Mindful attention + Values and committed action |
| DecenteringThe 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. | Behavioural | Decentering, Decentering + Values and committed action, Mindful attention + Decentering, Mindful attention + Decentering + Values and committed action |
| Values and committed actionThe 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. | Behavioural | Decentering + Values and committed action, Mindful attention + Decentering + Values and committed action, Mindful attention + Values and committed action, Values and committed action |
Primary outcome
Pain intensity (11-point Numeric Rating Scale, NRS)
Time frame: 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. A higher score yields more pain.
Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)
Time frame: 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. A higher score yields more pain.
18 secondary outcomes
Pain intensity (11-point Numeric Rating Scale, NRS)
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain intensity (11-point Numeric Rating Scale, NRS)
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)
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)
Time frame: Every day for 6 days following the first session (Td) for each treatment component
Pain burden (11-point Numeric Rating Scale, NRS)
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain burden (11-point Numeric Rating Scale, NRS)
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)
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)
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain frequency (1 item)
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain frequency (1 item)
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)
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)
Time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)
Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)
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)
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)
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)
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)
Time frame: Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 36948567Buskbjerg C, O'Toole MS, Zachariae R, Jensen AB, Frederiksen Y, Johansen C, von Heymann A, Speckens A, Johannsen M. Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark. BMJ Open. 2023 Mar 22;13(3):e066505. doi: 10.1136/bmjopen-2022-066505.
- Individual participant dataSharing planned: Yes. All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zachariae, DMSc principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful attention, Decentering and Values and committed action in people with Pain, Chronic and Breast Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilie R Buskbjerg, PhD (+4529842526, cdrc@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (11-point Numeric Rating Scale, NRS) (time frame: Baseline (T1) to 1 week after last session (Post-intervention, T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.