Adolescent Cancer Telemedicine for Pain Management

NCT03603886 | Completed

• 1 other identifier: 18-000223
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Change in pain coping behaviors as assessed by the Pain Coping Questionnaire (PCQ)

  At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group)

• Change in pain-related impairment as assessed by the PROMIS Pain Interference - Pediatric Short Form v2.0

  At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group)

Study Arms (2)

Telemedicine Pain Management

EXPERIMENTAL

Behavioral: Telemedicine Pain Management Intervention (immediate group)

Waitlist Control

OTHER

Treatment as usual comparator

Behavioral: Telemedicine Pain Management Intervention (waitlist group, intervention administered following 4-week waitlist period)

Interventions

Telemedicine Pain Management Intervention (immediate group) BEHAVIORAL

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

Telemedicine Pain Management Intervention (waitlist group, intervention administered following 4-week waitlist period) BEHAVIORAL

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.

Waitlist Control

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-21 years
• At least two months post cancer diagnosis
• Experienced pain in the past month as defined by at least one pain experience rated \>3 on a 0-10 Numeric Rating Scale
• Access to the internet for intervention sessions
• Fluent in English (Given that the intervention will be delivered in English, all adolescents will need to be fluent in English to participate.)

You may not qualify if:

• \. Significant cognitive impairment that may affect their ability to participate

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Rally Foundation for Childhood Cancer Research: collaborator
• Bear Necessities Pediatric Cancer Foundation: collaborator

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lonnie K Zeltzer, MD

  UCLA Pediatric Pain and Palliative Care Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: Waitlist control group receives intervention following waitlist period.

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 27, 2018
• Study Start: May 3, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)