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Advanced Solid TumorNCT04431830

Meaning-Centered Pain Coping Skills Training

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
9 Feb 2021to 3 May 2022
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; or stage III pancreatic or lung cancer diagnosis
  • At least moderate pain (worst pain in past week >/= 4 out of 10) at screening
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 2 at screening
  • Ability to speak and read English

Who cannot join

  • Brain tumor diagnosis
  • Significant cognitive impairment
  • Untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia)
  • Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
  • Enrollment in hospice

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain

This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. The third aim is to describe participants' experiences of MCPC using semi-structured qualitative interviews. 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 their most feared and distressing symptom. In this population, higher pain levels often predict worse physical, emotional, and existential/spiritual well-being. Psychosocial interventions show promise for improving cancer-related pain; however, no interventions address existential concerns (e.g., a loss of meaning in life) that are common among those facing pain from advanced illness. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain (e.g., guided imagery) in order to help them engage with what gives their life a sense of meaning, purpose, and significance.

This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients' pain and pain-related outcomes.

Being tested
Meaning-Centered Pain Coping Skills Training
Keywords
Solid Tumor Cancer, Pain, Meaning-Centered Psychotherapy, Pain Coping Skills Training, Meaning-Centered Pain Coping, Advanced Cancer
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 manage pain so that they can engage with what gives them a sense of meaning, purpose, and significance in life.

Study groups in NCT04431830
Study groupRoleWhat they receive
Meaning-Centered Pain Coping Skills TrainingExperimentalFour, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery) for managing pain.
Receives: Behavioral: Meaning-Centered Pain Coping Skills Training
Standard CareNo interventionInformation 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.

  1. Feasibility as measured by study accrual

    Treatment feasibility will be evidenced by meeting study accrual (N = 60).

    Measured: Baseline

  2. Feasibility as measured by adherence and assessment completion

    Treatment feasibility will be evidenced by at least 75% of participants completing all four intervention sessions as well as the 5-week follow-up assessment.

    Measured: 5-week follow-up (immediately post-intervention)

  3. Feasibility as measured by attrition

    Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up.

    Measured: 5-week follow-up (immediately post-intervention)

Secondary outcomes (7)

  1. Change in pain severity

    Pain severity will be measured using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain. The minimum value on this scale is 0 and the maximum value is 10. Higher scores represent worse outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

  2. Change in pain interference

    Pain interference will be measured using the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form. This measure assesses the degree to which pain has impacted patients' enjoyment of life and engagement in social, cognitive, emotional, physical, and recreational activities. The minimum value on this scale is 6 and the maximum value is 30. Higher scores represent worse outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

  3. Change in meaning in life

    Meaning in life (i.e., purpose, coherence, and significance) and overall spiritual well-being will be measured using the 12-item Functional Assessment of Cancer Therapy - Spiritual Well-Being scale (FACIT-Sp).The minimum value on each subscale is 0 and the maximum value is 4. Higher scores represent better outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

  4. Change in self-efficacy for pain management

    Self-efficacy for pain management will be measured using the Self-efficacy for Pain Management subscale of the Chronic Pain Self-Efficacy Scale. The subscale includes 5 items assessing 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.The minimum value on this scale is 10 and the maximum value is 100. Higher scores represent better outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

  5. Change in anxiety

    Anxiety will be measured using the 7-item version of the Generalized Anxiety Disorders scale (GAD-7), which assesses the frequency of nervousness, worry, difficulty relaxing, restlessness, irritability, and fear. The minimum value on this scale is 0 and the maximum value is 21. Higher scores represent worse outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

  6. Change in depressive symptoms

    Depressive symptoms will be measured using the 8-item version of the Patient Health Questionnaire (PHQ-8), which assesses the frequency of anhedonia, depressed mood, sleep difficulties, lack of energy, appetite disturbance, low self-esteem, trouble concentrating, and psychomotor retardation.The minimum value on this scale is 0 and the maximum value is 24. Higher scores represent worse outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

  7. Change in hopelessness

    Hopelessness will be measured using the Hopelessness Assessment in Illness Questionnaire. The scale includes 8 items assessing the degree to which patients have felt hopelessness, discouragement, and dread. The minimum value on this scale is 0 and the maximum value is 16. Higher scores represent worse outcomes.

    Measured: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start9 Feb 2021
  3. Primary completion31 Mar 2022
  4. Study completion3 May 2022

Resources

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 to an intervention or a standard care control condition.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04431830
Sponsor's protocol ID
Pro00105953
Status last verified
May 2022
First submitted
11 Jun 2020
Last updated
4 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Winger JG, Kelleher SA, Ramos K, Check DK, Yu JA, Powell VD, Lerebours R, Olsen MK, Keefe FJ, Steinhauser KE, Porter LS, Breitbart WS, Somers TJ. Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. Psychooncology. 2023 Jul;32(7):1096-1105. doi: 10.1002/pon.6151. Epub 2023 May 12.

    PubMed 37173865

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 4 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 4 May 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 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?

Feasibility as measured by study accrual (time frame: Baseline). The study lists 3 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 NCT04431830, 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 4 May 2022.

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