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Breast CancerICMPNCT06101849

Chronic Cancer Pain Management Program

A study testing I-Can-Manage-Pain after cancer (Pain Management Program) in people with Breast Cancer and Cancer, Treatment-Related, run by Hamilton Health Sciences Corporation at 1 site in Canada.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
I-Can-Manage-Pain after cancer (Pain Management Program)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteCanada
Study dates
3 Jan 2024to 30 May 2025
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

  • diagnosis of Stage 1-3 breast cancer;
  • had surgical excision at least 3 months ago;
  • completed neoadjuvant/adjuvant chemotherapy and/or radiation treatment at least 4 months ago;
  • within 5 years post active cancer treatment;
  • persistent pain within the last 3 months that is bothersome;
  • medical clearance to participate in the intervention
Show all 9Show fewer
  • over 18 years of age;
  • verbal fluency in English;
  • 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.

Who cannot join

  • Participants will be excluded from the study if they:
  • demonstrate significant cognitive impairment as determined by the clinical judgment of the provider;
  • have a pre-existing non-cancer pain condition,
  • have severe emotional distress that interferes with group participation as determined by scores above 15 on the Patient Health Questionnaire-9.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

Other trials in Canada

About this study

Official title: Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial

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.

Read the detailed description

Survivors of breast cancer often experience chronic pain that is undertreated and gets in the way of their functioning, relationships, mental health, and quality of life. There is little research on the best ways of treating chronic pain in cancer that make good use of all the expertise offered by different health care providers such as nurses, psychologists, and physiotherapists. In addition, little is known about how to offer such a service in an online format.

This study aims to pilot an online interprofessional pain management program for survivors of breast cancer. The investigators would like to know whether this treatment will help address the pain management concerns of patients, and whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT).

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 to assess their satisfaction and changes in outcomes related to pain, quality of life, confidence to manage their pain, and use of health care services. The feasibility of implementing the study and the program will be pre-determined by an acceptability criteria for patient recruitment, completion of questionnaires, participation in the online sessions, and satisfaction with the pain management program.

It is hoped that study findings will help inform the development of treatment programs to improve post-treatment pain management and the quality of life of survivors of breast cancer patients.

Being tested
I-Can-Manage-Pain after cancer (Pain Management Program)
Keywords
Pain, Breast Cancer, Cancer Pain, Pain Management, psycho-oncology, Psychology, quality of life
Medical subject headings
Breast Neoplasms, Neoplasms, Second Primary, Cancer Pain, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-Can-Manage-Pain after cancer (Pain Management Program)Behavioural

    6-week online interprofessional cancer pain management program (I-Can-Manage-Pain after cancer) for survivors of breast cancer. The program will cover the topics of understanding cancer pain, exercises to manage pain and psychological strategies to cope with pain

Study groups in NCT06101849
Study groupRoleWhat they receive
Cancer Pain Management GroupExperimentalParticipants 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
Receives: Behavioral: I-Can-Manage-Pain after cancer (Pain Management Program)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Interference.

    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.

    Measured: 6 weeks

Secondary outcomes (10)

  1. Pain intensity.

    The three-item PROMIS Pain Intensity-Short Form measures the severity of pain over a course of 7 days. Scores on this scale range from 3-15. Higher scores indicate higher pain intensity

    Measured: 6 weeks

  2. Pain Catastrophizing;

    Catastrophizing is the anticipation of negative pain experience and will be measured using the 13-item Pain Catastrophizing Scale. The scores on this scale range from 0-52 and higher scores indicate higher tendency for pain catastrophizing

    Measured: 6 weeks

  3. Psychological Distress (depression, anxiety, stress)

    Will be assessed by degree of depression, anxiety, stress. The 21-item Depression, Anxiety and Stress Scale (DASS-21) will be used to measure mood, anxiety and stress symptoms over the past week. Higher scores on the three subscales of depression, anxiety and stress indicate higher emotional distress.

    Measured: 6 weeks

  4. Psychological Distress (Fear of Cancer recurrence)

    Fear of cancer recurrence will be assessed using the 6-item Cancer Worry Scale (CWS). Score of 14 or above indicates high levels of fear of recurrence

    Measured: 6 weeks

  5. Self-Efficacy

    Will be assessed using the brief version of the cancer behavior inventory (CBI-B). The CBI is a 12-item measure examines the degree to which an individual feels confident in self-managing their cancer. This measure shows good internal consistency. Higher scores indicator greater confidence in self-managing cancer.

    Measured: 6 weeks

  6. Healthcare Utilization

    Will be assessed using the Health Service Utilization Questionnaire. This questionnaire assesses health care facility visits, procedures obtained and support services used. Higher numbers indicates more usage of healthcare services

    Measured: 6 weeks

  7. Patient Satisfaction

    Items 12-14 on the Patient Satisfaction Survey will be used to measure the extent to which patients understood the survey questions, and their satisfaction with the survey length

    Measured: 6 weeks

  8. Trial adherence and fidelity

    Percentage of participants completing the trial questionnaire and the intervention program.

    Measured: 12 months

  9. Trial Feasibility (ability to recruit patients)

    ability to recruit patients will be assessed using the trial screening and recruitment log. A recruitment of 1-2 participants per week is considered sufficient.

    Measured: 12 months

  10. Patients' satisfaction with the intervention.

    patients' satisfaction with the intervention will be measured using the patients' satisfaction survey (PSS). Scores on items 1-4 and 10-14 of PSS range between 1-5. Higher scores on items 1-4 and 10-14 indicates higher satisfaction. Other items will be analyzed qualitatively.

    Measured: 12 months

Timeline

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

  1. First posted26 Oct 2023
  2. Study start3 Jan 2024
  3. Primary completion30 Mar 2025
  4. Study completion30 May 2025

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A pre-post study design.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06101849
Sponsor's protocol ID
16187
Acronym
ICMP
Status last verified
Feb 2024
First submitted
28 Sep 2023
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Craig 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.

    PubMed 23159157

  • Orsmond 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.

    PubMed 26594739

  • Thabane 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.

    PubMed 20053272

  • Burckhardt 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.

    PubMed 15860132

  • Hamood 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.

    PubMed 28861642

  • Classification 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.

    PubMed 3461421

  • Feeney 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.

    PubMed 29404844

  • Wang K, Yee C, Tam S, Drost L, Chan S, Zaki P, Rico V, Ariello K, Dasios M, Lam H, DeAngelis C, Chow E. Prevalence of pain in patients with breast cancer post-treatment: A systematic review. Breast. 2018 Dec;42:113-127. doi: 10.1016/j.breast.2018.08.105. Epub 2018 Sep 4.

    PubMed 30243159

  • Forsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15.

    PubMed 23242613

  • Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.

    PubMed 18682712

  • Levy MH, Chwistek M, Mehta RS. Management of chronic pain in cancer survivors. Cancer J. 2008 Nov-Dec;14(6):401-9. doi: 10.1097/PPO.0b013e31818f5aa7.

    PubMed 19060605

  • Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

    PubMed 21435953

  • Novy DM, Aigner CJ. The biopsychosocial model in cancer pain. Curr Opin Support Palliat Care. 2014 Jun;8(2):117-23. doi: 10.1097/SPC.0000000000000046.

    PubMed 24690764

  • Paice JA, Portenoy R, Lacchetti C, Campbell T, Cheville A, Citron M, Constine LS, Cooper A, Glare P, Keefe F, Koyyalagunta L, Levy M, Miaskowski C, Otis-Green S, Sloan P, Bruera E. Management of Chronic Pain in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016 Sep 20;34(27):3325-45. doi: 10.1200/JCO.2016.68.5206. Epub 2016 Jul 25.

    PubMed 27458286

  • McCowat M, Fleming L, Vibholm J, Dixon D. The Psychological Predictors of Acute and Chronic Pain in Women Following Breast Cancer Surgery: A Systematic Review. Clin J Pain. 2019 Mar;35(3):261-271. doi: 10.1097/AJP.0000000000000672.

    PubMed 30531400

Questions about this trial

What is this clinical trial studying?

A study testing I-Can-Manage-Pain after cancer (Pain Management Program) in people with Breast Cancer and Cancer, Treatment-Related, run by Hamilton Health Sciences Corporation at 1 site in Canada.

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 9 inclusion and 4 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 25 Nov 2025. 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 Canada. 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?

Pain Interference. (time frame: 6 weeks). 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 NCT06101849, which also lists 39 linked publications.

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 25 Nov 2025.

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Chronic Cancer Pain Management Program (NCT06101849) | AzTrials