Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03149185
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2017-04-19
Brief Title:
Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
PC-CHIP
Brief Summary:
The purpose of this study is to examine the effects of various factors such as emotions stress stress management techniques for example relaxation and coping techniques and health information on quality of life distress depression coping and physical health in men diagnosed with advanced prostate cancer The investigators also evaluate the effectiveness of a 10-week group-based internet delivered psychosocial intervention Primary outcomes are symptom burden eg urinary function fatigue pain and HRQOL eg general physical social functioning
Participation in this study includes three face-to-face assessments baseline at the beginning of the research study 6-month follow-up and 12-month follow-up The 6- and 12-month follow-up interviews are conducted after the participant has completed the 10-week group intervention Participants are randomized into either an intervention group targets stress management skills - relaxation coping or a control group health information and health promotion strategies - benefits of proper nutrition and treatment compliance Both groups meet for 10 consecutive weeks through an internet video conferencing platform
At the baseline 6- and 12-month follow-ups the investigators collect blood and saliva samples The blood samples go through a three-day process in which the investigators extract and store serum plasma and cells for further analysis and gather proliferation data The investigators use the saliva to measure the cortisol diurnal rhythm
Participation in this study includes three face-to-face assessments baseline at the beginning of the research study 6-month follow-up and 12-month follow-up The 6- and 12-month follow-up interviews are conducted after the participant has completed the 10-week group intervention Participants are randomized into either an intervention group targets stress management skills - relaxation coping or a control group health information and health promotion strategies - benefits of proper nutrition and treatment compliance Both groups meet for 10 consecutive weeks through an internet video conferencing platform
At the baseline 6- and 12-month follow-ups the investigators collect blood and saliva samples The blood samples go through a three-day process in which the investigators extract and store serum plasma and cells for further analysis and gather proliferation data The investigators use the saliva to measure the cortisol diurnal rhythm
Detailed Description:
This 5-year study evaluates the effects of a 10-week technology-based and delivered cognitive-behavioral stress management intervention T-CBSM on symptom burden in men with advanced prostate cancer APC undergoing hormonal therapy HT or HT with prior radiotherapy RT andor radical prostatectomy RP APC is chronic and debilitating with survival rates about 32 and even lower rates for ethnic minorities Most 70 men diagnosed with APC receive HT to control progression HT is associated with side effects including depression fatigue hot flashes and sexual and urinary dysfunction while RT and RP also lead to fatigue irritation urinary dysfunction etc Symptoms combined with challenges of living with advanced disease eg unpredictable disease course significantly deteriorate health-related quality of life HRQOL Yet there is limited information on how psychosocial factors impact symptom burden or on the efficacy of psychosocial interventions in reducing symptom burden and improving HRQOL Furthermore psychosocial modulation of endocrine and immune function is associated with symptoms and HRQOL in cancer patients including those with advanced disease Stress-related disruption in diurnal cortisol can promote inflammation that can exacerbate symptoms eg fatigue depression pain In the investigaros pilot work the investigators observed that audio-based T-CBSM improves social and physical functioning and decreases symptom burden in APC Moreover targets of T-CBSM eg coping skills explain reductions in symptoms whereas decreases in inflammatory cytokines eg IL-1 IL-6 and enhanced cortisol regulation are associated with decreases in symptoms such as depression pain urinary dysfunction and fatigue The investigators propose to deliver an enhanced T-CBSM intervention to a capitalize on new technology using a video-conferencing for hard-to-reach and ethnically diverse patients b incorporate a neuroimmune model of symptom regulation and management and c test the efficacy of Web-CBSM in a multi-ethnic sample of 200 men living with APC Men will be randomized to a T-CBSM group intervention or a health promotion group T-HP control condition The investigators primary aims are to determine the extent to which randomization to T-CBSM relative to T-HP is associated with Aim 1 improved symptom burden management and HRQOL Aim 2 reduced distress and interpersonal disruption and improved stress management skills and Aim 3 improved neuroimmune regulation ie normalized diurnal cortisol decreases in inflammatory cytokines The investigators will also test Aim 4 a set of hypothesized pathways eg T-CBSM driven changes in distress stress management skills neuroimmune regulation etc that explain the association between group assignment and the primary outcomes of symptom burden and HRQOL This is a 2x3 randomized experimental design with condition T-CBSM vs T-HP as the between groups factor and time baseline T1 6-mos post-baseline T2 12-mos post-baseline T3 as the within groups factor
Experimental Design This is a randomized experimental trial designed to evaluate the effects of a 10-week technology-based group cognitive-behavioral stress management intervention vs a health promotion group-based attention matched control condition Primary outcomes are symptom burden eg urinary function fatigue pain and HRQOL eg general physical social functioning
Participants Participants will be 200 ethnically diverse men ages 50 or older with stage III or IV prostate cancer ie APC who are on hormonal treatment HT androgen ablation androgen deprivation chemical castration with or without radiotherapy RT Participants must also have undergone HT within the past 12 months
Experimental Design This is a randomized experimental trial designed to evaluate the effects of a 10-week technology-based group cognitive-behavioral stress management intervention vs a health promotion group-based attention matched control condition Primary outcomes are symptom burden eg urinary function fatigue pain and HRQOL eg general physical social functioning
Participants Participants will be 200 ethnically diverse men ages 50 or older with stage III or IV prostate cancer ie APC who are on hormonal treatment HT androgen ablation androgen deprivation chemical castration with or without radiotherapy RT Participants must also have undergone HT within the past 12 months
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