Clinical trial NCT03149185: Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
Official title: Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
advanced prostate cancer
technology based
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-11
Enrollment: 224
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized experimental trial designed to evaluate the effects of a 10-week technology-based group cognitive-behavioral stress management intervention (T-CBSM) vs. a health promotion (T-HP) group-based attention matched control condition. This is a 2 x 3 design with group assignment (T-CBSM vs. T-HP) as the between group factor, and time (baseline \[T1\], 6-months post-T1 \[T2\], and 12-months post T1 \[T3\]) as the within-group factor.
Primary purpose: SUPPORTIVE_CARE

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 (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.

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) 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 50 years of age
* Fluent in spoken English (6th grade level required to complete assessments and participate in groups)
* Diagnosis of Stage III or IV (T3/N1/ M0-T4/N3/M1) prostate cancer
* Received HT, or HT and RT treatment within the past year or is currently receiving HT, or HT and RT
* Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review
* Willingness to be randomized and followed for 12 months

Exclusion Criteria:

* Received treatment for a type of cancer other than prostate or skin cancer within the past 5 years or is currently receiving treatment for a cancer other than prostate or skin
* Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis), as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review
* Active alcohol abuse or dependence OR inpatient treatment for alcohol abuse within the last 6 months may be exclusionary, per P.I. discretion
* Active substance abuse or dependence OR inpatient treatment for substance abuse within the last 6 months may be exclusionary, per P.I. discretion
* Acute or chronic immune system medical conditions, medications or other conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Sjogren's disease, SLE, Hepatitis C, or any immunosuppressive treatment requiring conditions)
* Life expectancy \<12 months.

Primary outcomes:
measure: Change in symptom burden from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).
timeFrame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
measure: Change in HRQOL from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).
timeFrame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
Secondary outcomes:
Other outcomes:
measure: Distress & Positive/Negative Affect
timeFrame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
measure: Interpersonal Disruption
timeFrame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
measure: Stress Management Skills
timeFrame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
measure: Neuroimmune Regulation
timeFrame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Penedo FJ, Fox RS, Oswald LB, Moreno PI, Boland CL, Estabrook R, McGinty HL, Mohr DC, Begale MJ, Dahn JR, Flury SC, Perry KT, Kundu SD, Yanez B. Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial. Int J Behav Med. 2020 Oct;27(5):490-505. doi: 10.1007/s12529-019-09839-7.
citation: Fox RS, Moreno PI, Yanez B, Estabrook R, Thomas J, Bouchard LC, McGinty HL, Mohr DC, Begale MJ, Flury SC, Perry KT, Kundu SD, Penedo FJ. Integrating PROMIS(R) computerized adaptive tests into a web-based intervention for prostate cancer. Health Psychol. 2019 May;38(5):403-409. doi: 10.1037/hea0000672.