Perceptions of Side Effects of Cancer Chemoradiotherapy

NCT ID: NCT02978846

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-08-14

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasm Side Effect

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Clinical Observation

Intervention Type OTHER

Undergo side effects evaluation using cards

Interventions

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Clinical Observation

Undergo side effects evaluation using cards

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Williams

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31044307 (View on PubMed)

Other Identifiers

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NCI-2016-01260

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-15-17

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0S-15-17

Identifier Type: -

Identifier Source: org_study_id

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