Clinical trial NCT01599520: Stress Management Training for Latinas Receiving Chemotherapy
Official title: Stress Management Training for Latinas Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Stress
Keywords: cancer
stress
stress management
Latinas
Hispanics
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2012-05-16
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Week 5-7, Week 13 (to evaluate change)
measure: Impact of Event-Revised Intrusion Subscale (IES-R)
timeFrame: Baseline, Week 5-7, Week 13 (to evaluate change)
measure: Functional Assessment of Cancer Therapy--General Version
timeFrame: Baseline, 5-7 weeks, 13 weeks (to evaluate change)
measure: Functional Assessment of Chronic Illness-Spiritual Well-being Scale (FACIT-SP)
timeFrame: Baseline, 5-7 weeks, 13 weeks (to evaluate change)
Secondary outcomes:
measure: Memorial Symptom Assessment Scale-Short Form (MSAS-SF)
timeFrame: Baseline, 5-7 weeks, 13 weeks
measure: Measure of Current Status (MOCS)
timeFrame: Baseline, 5-7 weeks, 13 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Brian D Gonzalez, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: