Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01599520
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2012-04-23
Brief Title:
Stress Management Training for Latinas Receiving Chemotherapy
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Stress Management Training for Latinas Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 discDVD 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
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 discDVD 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None