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NCT01599520 · ClinicalTrials.gov registry record · NA

Stress Management Training for Latinas Receiving Chemotherapy

A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
NA
Development phase
140
Enrollment target

NCT01599520 is a NA study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 140 participants.

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The verdict

NCT01599520, a NA study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
NA
Development phase
140 participants
Enrollment target

Study Summary

Cancer patients receiving chemotherapy experience a number of aversive symptoms that are accompanied by declines in physical and mental well-being. Although the benefits of stress management training interventions on quality of life are well documented, there are no published studies examining the efficacy of these interventions among Hispanic women and Latinas (hereafter referred to as Latinas) receiving chemotherapy. This dearth of research reflects the general lack of stress management interventions for cancer patients whose preferred language is Spanish. Simply translating existing English-language interventions into Spanish may seem to be a solution for the lack of Spanish-language stress management interventions. This approach, however, does not take into account cultural values, beliefs and situational realities that are likely to contribute to patients' uptake of health promoting behaviors. The proposed research seeks to address this gap by evaluating a stress management training intervention developed specifically for Latinas beginning chemotherapy for cancer. In response to the identified need, the investigators created a Spanish-Language Self-Administered Stress Management Training (SL-SAT) intervention "Cómo tratar el estrés durante la quimioterapia" ("How to manage stress during chemotherapy"). The intervention is based on an English-language self-administered stress management training intervention the investigators previously developed and showed to be efficacious in a randomized controlled trial. Development of the Spanish-language intervention was the result of extensive use of ethnographic and learner verification methods, guided by a community-based participatory research approach. Similar to the English-language version, the SL-SAT intervention consists of a digital video disc(DVD), booklet, and audio compact disc (CD), and provides instruction in three well-established stress management techniques: deep breathing; progressive muscle relaxation

Interventions

  • BEHAVIORAL Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT)
  • BEHAVIORAL Usual Care Only

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2012-03-13
Est. Completion 2021-11-19
Phase NA

What the Registry Record Tells You About NCT01599520

The ClinicalTrials.gov registry entry for NCT01599520 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT) is the first listed.

NCT01599520 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01599520 about?

NCT01599520 is a clinical study titled "Stress Management Training for Latinas Receiving Chemotherapy". Cancer patients receiving chemotherapy experience a number of aversive symptoms that are accompanied by declines in physical and mental well-being. Although the benefits of stress management training interventions on quality of life are well documented, there are no published studies examining the e...

What is the current status of trial NCT01599520?

This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2012-03-13. Estimated completion is 2021-11-19.

What interventions are being tested in trial NCT01599520?

The interventions under investigation include: Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT) (BEHAVIORAL), Usual Care Only (BEHAVIORAL).

Who is sponsoring clinical trial NCT01599520?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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