NCT01599520

Stress Management Training for Latinas Receiving Chemotherapy

Completed NA Last updated 11 January 2022

What this trial tests

NA trial testing Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT) in Cancer in 140 participants. Completed in 19 November 2021.

Timeline

13 March 2012

Primary endpoint
1 September 2016

19 November 2021

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	140
Start date	13 March 2012
Primary completion	1 September 2016
Estimated completion	19 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT)
• Usual Care Only — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Stress — all drugs for Stress →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, female only, with Cancer or Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 and guided imagery; and use of coping self-statements. The proposed study will evaluate the efficacy of this transcreated intervention in a randomized controlled trial involving Spanish-speaking Latinas about to begin chemotherapy for cancer. Following a baseline assessment, participants will receive usual care or usual care plus the SL-SAT intervention. Participants will be reassessed on study measures approximately 7 and 13 weeks after the baseline assessment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of the Psychometric and Structural Properties of the Spanish Version of the Hospital Anxiety and Depression Scale in Latina Cancer Patients.
   Hyland KA, Hoogland AI, Gonzalez BD, Nelson AM, et al · · 2019 · cited 17× · PMID 31121250 · DOI 10.1016/j.jpainsymman.2019.05.003
2. Efficacy of a Spanish-Language Self-Administered Stress Management Training intervention for Latinas undergoing chemotherapy.
   Hoogland AI, Lechner SC, Gonzalez BD, Small BJ, et al · · 2018 · cited 15× · PMID 29462503 · DOI 10.1002/pon.4673