Clinical trial NCT03603886: Adolescent Cancer Telemedicine for Pain Management
Official title: Telemedicine Pain Control Program for Teens Undergoing Treatment for Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Rally Foundation for Childhood Cancer Research
name: Bear Necessities Pediatric Cancer Foundation
First posted: 2018-07-27
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist control group receives intervention following waitlist period.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attrition rate
timeFrame: Within 7 days of withdrawing from or completing the intervention
measure: Session attendance
timeFrame: Within 7 days of withdrawing from or completing the intervention
measure: Acceptance (measured via 3 categorical multiple choice questions assessing acceptability, impressions, and helpfulness of intervention)
timeFrame: Within 7 days of completing the intervention
Secondary outcomes:
measure: Change in pain coping behaviors as assessed by the Pain Coping Questionnaire (PCQ)
timeFrame: At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group)
measure: Change in pain-related impairment as assessed by the PROMIS Pain Interference - Pediatric Short Form v2.0
timeFrame: At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
Study officials:
affiliation: UCLA Pediatric Pain and Palliative Care Program
name: Lonnie K Zeltzer, MD
role: PRINCIPAL_INVESTIGATOR
References: