Perceptions of Side Effects of Cancer Chemoradiotherapy

Malignant Neoplasm Clinical Trial

Official title:

Patient Perceptions of Side Effects of Cancer Chemoradiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978846
• Other study ID #: 0S-15-17
• Secondary ID: NCI-2016-012600S
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: August 14, 2018

Study information

• Verified date: October 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 14, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Side Effect

Intervention

Other:
• Clinical Observation
Undergo side effects evaluation using cards

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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