Chronic Cancer Pain Management Program

Breast Cancer Clinical Trial

— ICMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101849
• Other study ID #: 16187
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Karen Zhang, PHD
• Phone: 905.521.2100
• Email: zhangka[@]HHSC.CA
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Pain
• Cancer, Treatment-Related
• Neoplasms, Second Primary
• Pain Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Country where clinical trial is conducted

Canada, 

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 weeks
Secondary	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	6 weeks
Secondary	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.	6 weeks
Secondary	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	6 weeks
Secondary	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.	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	Trial adherence and fidelity	Percentage of participants completing the trial questionnaire and the intervention program.	12 months
Secondary	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.	12 months
Secondary	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.	12 months