Stress Management Training for Latinas Receiving Chemotherapy

NCT01599520 | Completed

• 1 other identifier: MCC-16956
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Stress

Keywords

cancer; stress; stress management; Latinas; Hispanics

Outcome Measures

Primary Outcomes (4)

• Hospital Anxiety and Depression Scale (HADS)

  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.

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

• Impact of Event-Revised Intrusion Subscale (IES-R)

  The 8-item Intrusion Subscale from the IES-R measures intrusive thoughts, such as dreams, images, and reminders of a stressful event. In the present study, as in other research, it will be keyed to "your cancer and cancer diagnosis" in order to provide a measure of cancer-related distress. The IES-R has been validated in numerous populations and is widely used in cancer research. The validated Spanish version will be used in the current study.

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

• Functional Assessment of Cancer Therapy--General Version

  This 27-item measure has been used to assess health-related quality of life in patients with many different types of cancer. The validated Spanish version will be used in the current study.The FACT-G yields scores for physical, social/family, emotional, and functional well-being. Analyses will focus on emotional well-being scores as a primary outcome; other scales will be examined as secondary outcomes.

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

• Functional Assessment of Chronic Illness-Spiritual Well-being Scale (FACIT-SP)

  This 12-item scale is a valid and reliable measure of spiritual well-being in cancer patients. The validated Spanish version will be used in the current study. The FACIT-Sp yields scores for meaning/peace and faith as well as a total score. Analyses will focus on total FACIT-Sp scores as a primary outcome.

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

Secondary Outcomes (2)

• Memorial Symptom Assessment Scale-Short Form (MSAS-SF)

  Baseline, 5-7 weeks, 13 weeks

• Measure of Current Status (MOCS)

  Baseline, 5-7 weeks, 13 weeks

Study Arms (2)

Spanish-Language Self-Administered Training + Usual Care

EXPERIMENTAL

Participants randomized to this arm will receive Spanish-Language Self-Administered Training + Usual Care.

Behavioral: Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT)

Usual Care Only

ACTIVE COMPARATOR

Patients will be given the Spanish-language version of "Chemotherapy and You: Support for People with Cancer" ("La quimioterapia y usted: Apoyo para las personas con cancer") published by NCI. The intervention associate will review how it provides answers to common questions about chemotherapy, describes common side effects and their management, and identifies ways to obtain additional information. Patients will also be provided with a list of local support groups for cancer patients and informed that a social worker is available to meet with them without charge to discuss personal concerns or practical problems. At the first infusion, oncology nurses will provide all patients with standard education about the chemotherapy agents and anti-emetic agents to be administered, possible adverse reactions to these agents, and recommended precautions for avoiding illness and maintaining health.

Behavioral: Usual Care Only

Interventions

Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT) BEHAVIORAL

Patients will receive usual care. In addition, a Spanish-speaking intervention associate will spend an extra 10 minutes on the day usual care is initiated reviewing the self-administered training materials in Spanish titled "Cómo tratar el estrés durante la quimioterapia." Materials consist of an 18-minute DVD (also available as a videocassette (VC)), a 28-minute CD (also available as an audiocassette (AC)), a 16-page booklet, and a workbook to record practice and use of stress management techniques. Participants are instructed to first view the DVD/VC and then follow directions in the booklet and on the CD/AC about training, practice, and use of stress management techniques.

Spanish-Language Self-Administered Training + Usual Care

Usual Care Only BEHAVIORAL

Patients will be given the Spanish-language version of "Chemotherapy and You: Support for People with Cancer" ("La quimioterapia y usted: Apoyo para las personas con cancer") published by NCI. The intervention associate will review how it provides answers to common questions about chemotherapy, describes common side effects and their management, and identifies ways to obtain additional information. Patients will also be provided with a list of local support groups for cancer patients and informed that a social worker is available to meet with them without charge to discuss personal concerns or practical problems. At the first infusion, oncology nurses will provide all patients with standard education about the chemotherapy agents and anti-emetic agents to be administered, possible adverse reactions to these agents, and recommended precautions for avoiding illness and maintaining health.

Usual Care Only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Brian D Gonzalez, Ph.D

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: May 16, 2012
• Study Start: March 13, 2012
• Primary Completion: September 1, 2016
• Study Completion: November 19, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

US (1)