Clinical trial · Interventional
Chronic Cancer Pain Management Program
Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial
NCT06101849CI-TRIAL-00097936ICMPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this research study is to evaluate an online inter-professional pain management program for survivors of breast cancer. The main questions it aims to answer: 1. whether this treatment will help address the pain management concerns of patients, 2. whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT). Participants will be asked to attend a 6-week online pain management group sessions (1h/week). Participants will also be asked to fill out questionnaires before and after the program completion.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Treatment-Related | Malignant Neoplasm | ALIAS | 0.85 |
| Pain Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| I-Can-Manage-Pain after cancer (Pain Management Program) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cancer Pain Management Group
- description
- Participants in the study will attend a 6-week online pain management program (I-Can-Manage-Pain after cancer) that will cover the topics of understanding cancer pain, exercises to manage pain and psychological strategies to cope with pain. Questionnaires will be administered before and after the program
- interventionNames
- Behavioral: I-Can-Manage-Pain after cancer (Pain Management Program)
Primary outcomes (1)
- measure
- Pain Interference.
- timeFrame
- 6 weeks
- description
- This construct will be measured using the 6-item Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale. (PIS) The PIS uses a 5-point rating scale to determine the degree to which an individual perceives their pain symptoms to interfere with their physical, mental and social functioning. Sum of raw scores will be translated to a T-score using a conversion table. A T-score of 50 with a standard deviation of 10 is the average for the general population based on United States Data. The minimally important difference20 for the PIS scores among pain samples ranges from 2 to 3 T-score points.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. diagnosis of Stage 1-3 breast cancer; 2. had surgical excision at least 3 months ago; 3. completed neoadjuvant/adjuvant chemotherapy and/or radiation treatment at least 4 months ago; 4. within 5 years post active cancer treatment; 5. persistent pain within the last 3 months that is bothersome; 6. medical clearance to participate in the intervention 7. over 18 years of age; 8. verbal fluency in English; 9. have access to internet and technology to participate in the online program. Patients currently receiving adjuvant endocrine therapy or molecularly targeted therapies or who have completed these therapies within the last 5 years are eligible to participate. Exclusion Criteria: * Participants will be excluded from the study if they: 1. demonstrate significant cognitive impairment as determined by the clinical judgment of the provider; 2. have a pre-existing non-cancer pain condition, 3. have severe emotional distress that interferes with group participation as determined by scores above 15 on the Patient Health Questionnaire-9.
References
Publications (39)
- BACKGROUNDCraig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available. PMID 23159157
- BACKGROUNDOrsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. doi: 10.1177/1539449215578649. PMID 26594739
- BACKGROUNDThabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. PMID 20053272
- BACKGROUNDBurckhardt CS, Jones KD. Effects of chronic widespread pain on the health status and quality of life of women after breast cancer surgery. Health Qual Life Outcomes. 2005 Apr 28;3:30. doi: 10.1186/1477-7525-3-30. PMID 15860132
- BACKGROUNDHamood R, Hamood H, Merhasin I, Keinan-Boker L. Chronic pain and other symptoms among breast cancer survivors: prevalence, predictors, and effects on quality of life. Breast Cancer Res Treat. 2018 Jan;167(1):157-169. doi: 10.1007/s10549-017-4485-0. Epub 2017 Aug 31. PMID 28861642
- BACKGROUNDClassification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available. PMID 3461421
- BACKGROUNDFeeney LR, Tormey SM, Harmon DC. Breast cancer and chronic pain: a mixed methods review. Ir J Med Sci. 2018 Nov;187(4):877-885. doi: 10.1007/s11845-018-1760-y. Epub 2018 Feb 5. PMID 29404844