Perceptions of Side Effects of Cancer Chemoradiotherapy

NCT02978846 | Completed DMC

• 3 other identifiers: 0S-15-17NCI-2016-01260P30CA014089
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm; Side Effect

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Clinical Observation OTHER

Undergo side effects evaluation using cards

Observational (side effects evaluation using cards)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients undergoing radiation therapy with or without chemotherapy.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• 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.

  PMID: 31044307 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Patrick Williams

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: December 1, 2016
• Study Start: June 1, 2016
• Primary Completion: August 2, 2018
• Study Completion: August 14, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (1)