Adolescent Cancer Telemedicine for Pain Management

Cancer Clinical Trial

Official title:

Telemedicine Pain Control Program for Teens Undergoing Treatment for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603886
• Other study ID #: 18-000223
• Status: Completed
• Phase: N/A
• Start date: May 3, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain in adolescents undergoing treatment for cancer is a common problem, often related to treatment or to the cancer itself. Due to increasing outpatient-based cancer treatment, the burden of care and pain management has shifted to the home environment. Yet, there are limited interventions that target the management of pain at home. Adolescence is marked by increased need for independence and social integration, both of which can be impaired by pain or fear of pain. To address unique needs during this developmental period, this study will test a telemedicine program to enhance pain knowledge and pain control strategies in adolescents ages 12-21 years who are undergoing treatment for cancer. Fifty-six teens will be randomized to an intervention or wait-list control condition. Patients randomized to the waitlist control condition will receive the intervention following completion of the waitlist condition. The intervention will consist of four weekly 30-45 minute telemedicine (online via videoconferencing platform) sessions with a trained social work or psychology provider. Sessions will focus on pain psychoeducation, coping tools, communication, and stress management. Participants will complete online questionnaires assessing pain coping, pain management, and pain-related impairment at pre-intervention, post-intervention, and 1- and 2-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Age 12-21 years

2. At least two months post cancer diagnosis

3. Experienced pain in the past month as defined by at least one pain experience rated >3 on a 0-10 Numeric Rating Scale

4. Access to the internet for intervention sessions

5. Fluent in English (Given that the intervention will be delivered in English, all adolescents will need to be fluent in English to participate.)

Exclusion Criteria:

1. Significant cognitive impairment that may affect their ability to participate

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Telemedicine Pain Management Intervention (immediate group)
Four weekly telemedicine pain management sessions with a trained provider. Intervention will be delivered via video conferencing platform, and each session will last between 30 and 45 minutes. Intervention topics will include: pain psychoeducation, pain coping tools, pain communication, and pain-related stress management.
• Telemedicine Pain Management Intervention (waitlist group, intervention administered following 4-week waitlist period)
Four week waitlist period during which participants receive treatment as usual. Following the waitlist period, participants will receive the telemedicine pain management intervention: Four weekly telemedicine pain management sessions with a trained provider. Intervention will be delivered via video conferencing platform, and each session will last between 30 and 45 minutes. Intervention topics will include: pain psychoeducation, pain coping tools, pain communication, and pain-related stress management.

Locations

Country	Name	City	State
United States	University of California, Los Angeles (UCLA)	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Bear Necessities Pediatric Cancer Foundation, Rally Foundation for Childhood Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition rate	Determined by the percentage of participants who drop out of the study. An attrition rate of 20% or less will indicate feasibility.	Within 7 days of withdrawing from or completing the intervention
Primary	Session attendance	Determined by the number of sessions that participants attend (out of 4 total sessions). To be considered feasible, 80% of participants must have completed at least 3 of the sessions within a 6-week period.	Within 7 days of withdrawing from or completing the intervention
Primary	Acceptance (measured via 3 categorical multiple choice questions assessing acceptability, impressions, and helpfulness of intervention)	Intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "4" ("Agree") on a 5-point scale anchored by "Strongly Disagree" and "Strongly Agree."	Within 7 days of completing the intervention
Secondary	Change in pain coping behaviors as assessed by the Pain Coping Questionnaire (PCQ)	Assessed by the change in the total score on the 'Coping with Pain' section of the Pain Coping Questionnaire (PCQ) from pre-intervention to post-intervention (immediate group) or post-waitlist period (waitlist group). Calculated by subtracting the pre-intervention score from the post-intervention score. The 'Coping with Pain' section of the PCQ consists of 39 items. The total score is calculated as a mean rating and can range from 1-5 and higher scores indicate greater use of coping strategies.	At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group)
Secondary	Change in pain-related impairment as assessed by the PROMIS Pain Interference - Pediatric Short Form v2.0	Assessed by the change in the total score on the PROMIS Pain Interference - Pediatric Short Form v2.0 from pre-intervention to post-intervention (immediate group) or post-waitlist period (waitlist group). Calculated by subtracting the pre-intervention score from the post-intervention score. The PROMIS Pain Interference - Pediatric Short Form v2.0 is an 8-item measure whose total score can range from 8-40. Higher scores indicate higher interference caused by pain.	At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group)