Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03149185 |
Other study ID # |
STU00064136 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 25, 2012 |
Est. completion date |
April 22, 2018 |
Study information
Verified date |
May 2017 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 (e.g., urinary function, fatigue, pain) and HRQOL (e.g., 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.
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) and/or 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 (e.g., 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 (e.g., 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 (e.g., coping
skills) explain reductions in symptoms, whereas decreases in inflammatory cytokines (e.g.,
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 (i.e., normalized diurnal cortisol & decreases in inflammatory
cytokines). The investigators will also test (Aim 4) a set of hypothesized pathways (e.g.,
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 (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical &
social functioning).
Participants. Participants will be 200 ethnically diverse men ages 50 or older, with stage
III or IV prostate cancer (i.e., 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.