Clinical trial NCT06101849: Chronic Cancer Pain Management Program
Official title: Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Cancer, Treatment-Related
Pain Cancer
Keywords: Pain
Breast Cancer
Cancer Pain
Pain Management
psycho-oncology
Psychology
quality of life
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2023-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pre-post study design.
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Interference.
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain intensity.
timeFrame: 6 weeks
measure: Pain Catastrophizing;
timeFrame: 6 weeks
measure: Psychological Distress (depression, anxiety, stress)
timeFrame: 6 weeks
measure: Psychological Distress (Fear of Cancer recurrence)
timeFrame: 6 weeks
measure: Self-Efficacy
timeFrame: 6 weeks
measure: Healthcare Utilization
timeFrame: 6 weeks
measure: Patient Satisfaction
timeFrame: 6 weeks
measure: Trial adherence and fidelity
timeFrame: 12 months
measure: Trial Feasibility (ability to recruit patients)
timeFrame: 12 months
measure: Patients' satisfaction with the intervention.
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Karen Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
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