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Adolescent Cancer Telemedicine for Pain Management

NCT ID: NCT03603886

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-03

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Waitlist control group receives intervention following waitlist period.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telemedicine Pain Management

Group Type EXPERIMENTAL

Telemedicine Pain Management Intervention (immediate group)

Intervention Type 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.

Waitlist Control

Treatment as usual comparator

Group Type OTHER

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rally Foundation for Childhood Cancer Research

OTHER

Sponsor Role collaborator

Bear Necessities Pediatric Cancer Foundation

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Lonnie Zeltzer

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lonnie K Zeltzer, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA Pediatric Pain and Palliative Care Program

Locations

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University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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18-000223

Identifier Type: -

Identifier Source: org_study_id