Perceptions of Side Effects of Cancer Chemoradiotherapy

Patient Perceptions of Side Effects of Cancer Chemoradiotherapy

This study is asking patients who are undergoing radiation therapy with or without chemotherapy on how well they evaluate their side effects on the last day of treatment. This study is not to change health outcomes of the patients in this study. Asking patients to rank side effects in order of which ones bother them the most may help researchers identify the most troubling side effects of cancer treatment.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm; Side Effect
• Intervention / Treatment: Other: Clinical Observation

Detailed Description

PRIMARY OBJECTIVES:

I. To examine the perceptions of side effects and their subjective severity of patients treated with radiotherapy with and without concurrent chemotherapy at Los Angeles County (LAC) + University of Southern California (USC) Medical Center.

SECONDARY OBJECTIVES:

I. To identify the most troubling side effects of patients treated with radiotherapy with and without concurrent chemotherapy at LAC+USC Medical Center.

II. To evaluate the impact of chemotherapy combined with radiation therapy, in regards to whether or not perceptions of side effects are altered by what cancer treatment is given.

OUTLINE:

Patients are shown two groups of cards on the last day of radiation treatment. Group A lists 48 physical side effects and group B lists 27 psychosocial side effects. The cards are shuffled and patients view one card at a time and select the side effects they attribute to their current treatment. Patients rank the selected cards from each group by order of severity. The top 5 cards from each group are then shuffled together and patients rank the remaining 10 cards in order of severity.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients undergoing radiation therapy with or without chemotherapy.

Description

Inclusion Criteria:

• Diagnosis of cancer
• Has received at least 4 consecutive weeks of definitive radiation treatment, with or without concurrent chemotherapy
• Has not received greater than 4 weeks of chemotherapy prior to radiation therapy start
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Patients with either a central nervous system (CNS)-primary cancer or with brain metastases

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (side effects evaluation using cards); Patients are shown two groups of cards on the last day of radiation treatment. Group A lists 48 physical side effects and group B lists 27 psychosocial side effects. The cards are shuffled and patients view one card at a time and select the side effects they attribute to their current treatment. Patients rank the selected cards from each group by order of severity. The top 5 cards from each group are then shuffled together and patients rank the remaining 10 cards in order of severity.

Other: Clinical Observation; Undergo side effects evaluation using cards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the most common type of side effects as perceived by patients on the last day of radiation treatment	Tables and bar charts will be used to display the 10-20 highest ranked side effects overall, by sex and concurrent chemotherapy. Descriptive statistics such as means and standard deviation will be used.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Patrick Williams, University of Southern California

Publications and helpful links

General Publications

• Williams PA, Cao S, Yang D, Jennelle RL. Patient-reported outcomes of the relative severity of side effects from cancer radiotherapy. Support Care Cancer. 2020 Jan;28(1):309-316. doi: 10.1007/s00520-019-04820-2. Epub 2019 May 2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): August 14, 2018

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 0S-15-17 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2016-01260 (Registry Identifier: CTRP (Clinical Trial Reporting Program))