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Clinical Trials/NCT03603886
NCT03603886
Completed
Not Applicable

Telemedicine Pain Control Program for Teens Undergoing Treatment for Cancer

University of California, Los Angeles1 site in 1 country10 target enrollmentMay 3, 2019
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
University of California, Los Angeles
Enrollment
10
Locations
1
Primary Endpoint
Attrition rate
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2019
End Date
July 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lonnie Zeltzer

Distinguished Professor

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • 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.)

Exclusion Criteria

  • Significant cognitive impairment that may affect their ability to participate

Outcomes

Primary Outcomes

Attrition rate

Time Frame: Within 7 days of withdrawing from or completing the intervention

Determined by the percentage of participants who drop out of the study. An attrition rate of 20% or less will indicate feasibility.

Session attendance

Time Frame: Within 7 days of withdrawing from or completing the intervention

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.

Acceptance (measured via 3 categorical multiple choice questions assessing acceptability, impressions, and helpfulness of intervention)

Time Frame: Within 7 days of completing the 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."

Secondary Outcomes

  • 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 Sites (1)

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