Chronic Cancer Pain Management Program

NCT06101849 | Completed

• 1 other identifier: 16187
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 1.whether this treatment will help address the pain management concerns of patients,
2. 2.whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT).

Conditions

Breast Cancer; Cancer, Treatment-Related; Pain Cancer

Keywords

Pain; Breast Cancer; Cancer Pain; Pain Management; psycho-oncology; Psychology; quality of life

Outcome Measures

Primary Outcomes (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.

  6 weeks

Secondary Outcomes (10)

• Pain intensity.

  6 weeks

• Pain Catastrophizing;

  6 weeks

• Psychological Distress (depression, anxiety, stress)

  6 weeks

• Psychological Distress (Fear of Cancer recurrence)

  6 weeks

• Self-Efficacy

  6 weeks

Study Arms (1)

Cancer Pain Management Group

EXPERIMENTAL

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

Behavioral: I-Can-Manage-Pain after cancer (Pain Management Program)

Interventions

I-Can-Manage-Pain after cancer (Pain Management Program) BEHAVIORAL

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

Cancer Pain Management Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Publications (39)

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  BACKGROUND

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  BACKGROUND

• Canadian Pain Task Force. (June, 2019). Chronic pain in Canada: Laying a foundation for action.https://www.canada.ca/content/dam/hc-sc/documents/corporate/about-health-canada/publicengagement/external-advisory-bodies/canadian-pain-task-force/report-2019/canadian-pain-task-forceJune-2019-report-en.pdf

  BACKGROUND

• Cancer Care Ontario. (April, 2012). Cancer-related pain management. Cancer Care Ontario: Toronto, ON.

  BACKGROUND

• The British Pain Society. (November 2013). Guidelines for pain management programmes for adults: An evidence-based review prepared on behalf of the British Pain Society. https://www.britishpainsociety.org/static/uploads/resources/files/pmp2013_main_FINAL_v6.pdf

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Second Primary; Cancer Pain; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Karen Zhang, PHD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical, Health and Rehabilitation Psychologist

Model Details: A pre-post study design.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 26, 2023
• Study Start: January 3, 2024
• Primary Completion: March 30, 2025
• Study Completion: May 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)