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A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer

NCT01954420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2019-11-19

No results posted yet for this study

Summary

The purpose of the research is to test the efficacy of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer treatment, and to evaluate moderators and mediators of intervention effects. The intervention uses guided imagery, relaxation exercises, and nature sound recordings, self-administered via an MP3 player. The study will determine (1) if the intervention helps to control symptoms during chemotherapy, (2) if personal and clinical characteristics influence how well the intervention works, and (3) if the cognitive-behavioral strategies reduce markers of stress and inflammation found in blood and saliva.

Conditions

Interventions

BEHAVIORAL

Cognitive-Behavioral Intervention

Standard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player.

OTHER

Attention Control

Standard care + Cancer education

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Kristine Kwekkeboom, PhD., RN · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01954420 on ClinicalTrials.gov