Clinical trial NCT02978846: Perceptions of Side Effects of Cancer Chemoradiotherapy
Official title: Patient Perceptions of Side Effects of Cancer Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm
Side Effect
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-12-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients undergoing radiation therapy with or without chemotherapy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify the most common type of side effects as perceived by patients on the last day of radiation treatment
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Patrick Williams
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.