Stress Management Training for Latinas Receiving Chemotherapy



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:January 9, 2012
End Date:April 2019

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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.

Specific aims of the project are:

1. To evaluate the impact of Cómo tratar el estrés durante la quimioterapia on quality of
life during chemotherapy relative to usual care only. Consistent with prior research,
the investigators hypothesize that the intervention will result in better psychological
and spiritual well-being and less anxiety, depression, and cancer-related distress.

2. To investigate the mechanism by which Cómo tratar el estrés durante la quimioterapia
improves quality of life during chemotherapy. Based on relevant theory and prior
research, the investigators hypothesize that improvement in perceived self-efficacy in
managing stress will explain beneficial effects of the intervention on quality of life
outcomes.

3. To examine whether communication and sociocultural factors associated with the
acculturation process moderate the impact of Cómo tratar el estrés durante la
quimioterapia on quality of life. Based on relevant theory and prior research, the
investigators hypothesize that, among women who receive the intervention, those who have
a stronger preference for communicating and receiving information in Spanish will
benefit more.

Inclusion Criteria:

- Be at least 18 years old

- Be female

- Self-identify as Hispanic or Latina

- Be capable of speaking and reading Spanish

- Be diagnosed with cancer

- Be scheduled to start outpatient intravenous (IV) chemotherapy for reasons other than
symptom palliation at Moffitt Cancer Center (MCC)

- Be scheduled to receive chemotherapy on one of the five schedules specified in Table 3

- Have not received chemotherapy in the past 2 months

- Have no documented or observable visual, auditory, psychiatric, or neurological
disorders that would interfere with participation (e.g., blindness, deafness,
psychosis, or dementia)

- Be able to provide written informed consent

Exclusion Criteria:

- No exclusion criteria
We found this trial at
1
site
Tampa, Florida 33612
Principal Investigator: Paul B. Jacobsen, Ph.D.
Phone: 813-745-1810
?
mi
from
Tampa, FL
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