Advanced Solid TumorMCPCNCT05385965
Meaning-Centered Pain Coping Skills Training for Cancer Pain
A study testing Meaning-Centered Pain Coping Skills Training in people with Advanced Solid Tumor and Pain, run by Duke University at 1 site in United States.
Trial summary
This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference will be randomized to MCPC or a standard care control condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Pain
- What is being tested?
- Meaning-Centered Pain Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 8 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV solid tumor cancer diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- At least one clinical pain severity rating > 0 out of 10 in past month
- At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference T-score >/= 55) in the past week at telephone screening
- Ability to speak and read in English
- Age >/= 18 years.
Who cannot join
- Significant cognitive impairment as indicated in medical chart or during telephone screening
- Serious untreated mental illness
- Primary brain cancer diagnosis
- Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
- Enrollment in hospice at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meaning-Centered Pain Coping Skills Training: A Randomized Controlled Trial of a Psychosocial Intervention for Advanced Cancer Patients
This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).
Read the detailed description
Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer.
To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize patients to MCPC or enhanced usual care control (target N = 210). Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace.
The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.
- Conditions
- Advanced Solid Tumor, Pain
- Being tested
- Meaning-Centered Pain Coping Skills Training
- Keywords
- Caner pain management, Psychosocial intervention, Spiritual aspects of coping with pain, Pain Coping Skills Training, Meaning-Centered Psychotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Pain Coping Skills TrainingBehavioural
The goal of this intervention is to help participants reduce pain interference so that they can engage with what gives them a sense of meaning, purpose, and peace.
| Study group | Role | What they receive |
|---|---|---|
| Meaning-Centered Pain Coping Skills Training | Experimental | Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain. Receives: Behavioral: Meaning-Centered Pain Coping Skills Training |
| Standard Care | No intervention | Information and referrals for free services available through the Duke Cancer Patient Support Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference.
Measured: 8-week follow-up
Secondary outcomes (9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference.
Measured: 12-week follow-up
Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale
This 4-item measure assesses pain severity at its worst, least, and average over the past 7 days as well as current pain severity. Response options range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate worse pain severity.
Measured: 8-week follow-up and 12-week follow-up
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
This 12-item measure references the past 7 days and includes an overall spiritual well-being score and three subscales: 1) meaning (i.e., reason for living, sense of meaning and purpose); 2) peace (i.e., feeling peaceful, sense of harmony within oneself); and 3) faith (i.e., finding strength and comfort in faith or spiritual beliefs). Response options range from 0 (not at all) to 4 (very much); two items are reverse coded. Higher scores indicate greater spiritual well-being.
Measured: 8-week follow-up and 12-week follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale
This 8-item measure assesses feelings of meaning and purpose, including having a good sense of what makes one's life meaningful, a sense that one's life is valuable and worthwhile, having clear goals and aims, feeling life one's life has meaning, significance, direction, fulfillment, and purpose. Response options range from 1 (strongly disagree or not at all) to 5 (strongly agree or very much). Higher scores indicate greater meaning and purpose.
Measured: 8-week follow-up and 12-week follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form
This 8-item measure assesses anxiety symptoms over the past 7 days, including fear, difficulty focusing on things other than anxiety, feeling overwhelmed by worries, feeling uneasy, nervousness, feeling the need for help with anxiety, feeling anxious, and feeling tense. Response options range from 1 (never) to 5 (always). Higher scores indicate worse anxiety.
Measured: 8-week follow-up and 12-week follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form
This 8-item measure assesses depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, hopelessness, depression, failure, unhappiness, nothing to look forward to, and difficulty improving mood. Response options range from 1 (never) to 5 (always). Higher scores indicate worse depressive symptoms.
Measured: 8-week follow-up and 12-week follow-up
Chronic Pain Self-Efficacy Scale (CPS)
This 5-item measures assesses patients' confidence regarding pain management, managing pain during daily activities, keeping pain from interfering with sleep, and confidence in their ability to reduce pain using methods other than taking additional medication. Response options range from 10 (not at all certain) to 100 (very certain). Higher scores indicate greater self-efficacy.
Measured: 8-week follow-up and 12-week follow-up
Medical Outcomes Study Social Support Survey (MOS-SS)
This 8-item measure assesses how often someone was available to provide instrumental (i.e., practical) support and emotional support. Instrumental support includes having someone available if confided to bed, needing to visit a doctor, needing help preparing meals, and needing help with daily chores. Emotional support includes having someone available to have a good time with, turn to for suggestions, feel understood, and feel loved and wanted. Response options range from 1 (none of the time) to 5 (all of the time). Higher scores indicate greater social support.
Measured: 8-week follow-up and 12-week follow-up
5-item 5-level EuroQol Group (EQ-5D-5L)
This 5-item measure assesses health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The response options range from 1 to 5, with response choices that vary per question. Higher scores indicate worse health-related quality of life.
Measured: 8-week follow-up and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start9 Feb 2023
- Primary completion10 Apr 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned with equal allocation to an intervention or a standard care control condition, using a stratified block randomization scheme to ensure group balance based on patient performance status (i.e., Eastern Cooperative Oncology Group \[ECOG\] score of 0 vs. 1 or 2) and pain interference (i.e., Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference 8-item raw score of 25 or lower vs. 26 or higher) at screening.
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph G Winger, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385965
- Sponsor's protocol ID
- Pro00110762
- Acronym
- MCPC
- Status last verified
- May 2026
- First submitted
- 27 Apr 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meaning-Centered Pain Coping Skills Training: A Randomized Controlled Trial of a Psychosocial Intervention for Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT05385965
- Acronym / sponsor ID
- MCPC / Pro00110762
- Conditions
- Advanced Solid Tumor, Pain
- Keywords
- Caner pain management, Psychosocial intervention, Spiritual aspects of coping with pain, Pain Coping Skills Training, Meaning-Centered Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 23 May 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.
This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).
Detailed description
Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer.
To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize patients to MCPC or enhanced usual care control (target N = 210). Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace.
The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned with equal allocation to an intervention or a standard care control condition, using a stratified block randomization scheme to ensure group balance based on patient performance status (i.e., Eastern Cooperative Oncology Group [ECOG] score of 0 vs. 1 or 2) and pain interference (i.e., Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference 8-item raw score of 25 or lower vs. 26 or higher) at screening.
| Arm | Type | Receives |
|---|---|---|
| Meaning-Centered Pain Coping Skills Training | Experimental | Behavioral: Meaning-Centered Pain Coping Skills TrainingFour, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain. |
| Standard Care | No intervention | –Information and referrals for free services available through the Duke Cancer Patient Support Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage IV solid tumor cancer diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- At least one clinical pain severity rating > 0 out of 10 in past month
- At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference T-score >/= 55) in the past week at telephone screening
- Ability to speak and read in English
Key exclusion criteria (5 listed)
- Significant cognitive impairment as indicated in medical chart or during telephone screening
- Serious untreated mental illness
- Primary brain cancer diagnosis
- Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
- Enrollment in hospice at screening
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 |
|---|---|---|
| Meaning-Centered Pain Coping Skills TrainingThe goal of this intervention is to help participants reduce pain interference so that they can engage with what gives them a sense of meaning, purpose, and peace. | Behavioural | Meaning-Centered Pain Coping Skills Training |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
Time frame: 8-week follow-up
This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference.
9 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
Time frame: 12-week follow-up
Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale
Time frame: 8-week follow-up and 12-week follow-up
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
Time frame: 8-week follow-up and 12-week follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale
Time frame: 8-week follow-up and 12-week follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form
Time frame: 8-week follow-up and 12-week follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form
Time frame: 8-week follow-up and 12-week follow-up
Chronic Pain Self-Efficacy Scale (CPS)
Time frame: 8-week follow-up and 12-week follow-up
Medical Outcomes Study Social Support Survey (MOS-SS)
Time frame: 8-week follow-up and 12-week follow-up
5-item 5-level EuroQol Group (EQ-5D-5L)
Time frame: 8-week follow-up and 12-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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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.
Joseph G Winger, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meaning-Centered Pain Coping Skills Training in people with Advanced Solid Tumor and Pain, run by Duke University at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 12 May 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form (time frame: 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.