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Stress Management Training for Latinas Receiving Chemotherapy


N/A
18 Years
N/A
Open (Enrolling)
Female
Cancer, Stress

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Trial Information

Stress Management Training for Latinas Receiving Chemotherapy


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 MCC or SCCC

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Hospital Anxiety and Depression Scale (HADS)

Outcome Description:

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.

Outcome Time Frame:

Baseline, Week 5-7, Week 13 (to evaluate change)

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

16956

NCT ID:

NCT01599520

Start Date:

April 2012

Completion Date:

December 2015

Related Keywords:

  • Cancer
  • Stress
  • cancer
  • stress
  • stress management
  • Latinas
  • Hispanics

Name

Location

Moffitt Cancer CenterTampa, Florida  33612