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

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

This 14-item measure has been used widely in behavioral oncology research because it does not assess somatic symptoms of anxiety and depression (e.g., fatigue) that may be confounded with disease- or treatment-related symptoms. The validated Spanish version will be used in the current study. Analyses will focus on the total score as a primary outcome.

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 finished NCT01599520 record still lists

NCT01599520 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01599520's enrollment target sits among peer trials

140 713th of 2000 higher than 1,281 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01599520, the US trial registry maintained by the National Library of Medicine. NCT01599520 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.