Overview

This trial is active, not recruiting.

Conditions cancer, stress
Treatments spanish-language self-administered training plus usual care (sl-sat), usual care only
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator American Cancer Society, Inc.
Start date January 2012
End date May 2017
Trial size 139 participants
Trial identifier NCT01599520, MCC-16956

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Participants randomized to this arm will receive Spanish-Language Self-Administered Training + Usual Care.
spanish-language self-administered training plus usual care (sl-sat)
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.
(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.
usual care only
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.

Primary Outcomes

Measure
Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline, Week 5-7, Week 13 (to evaluate change)
Impact of Event-Revised Intrusion Subscale (IES-R)
time frame: Baseline, Week 5-7, Week 13 (to evaluate change)
Functional Assessment of Cancer Therapy--General Version
time frame: Baseline, 5-7 weeks, 13 weeks (to evaluate change)
Functional Assessment of Chronic Illness-Spiritual Well-being Scale (FACIT-SP)
time frame: Baseline, 5-7 weeks, 13 weeks (to evaluate change)

Secondary Outcomes

Measure
Memorial Symptom Assessment Scale-Short Form (MSAS-SF)
time frame: Baseline, 5-7 weeks, 13 weeks
Measure of Current Status (MOCS)
time frame: Baseline, 5-7 weeks, 13 weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Stress Management Training for Latinas Receiving Chemotherapy
Principal investigator Cathy Meade, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.
Location data was received from the National Cancer Institute and was last updated in October 2016.