Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Technology based cognitive behavioral stress management
* Behavioral: Technology based health promotion group-based attention matched control condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T-CBSM<br>Technology based cognitive behavioral stress management. | Behavioral: Technology based cognitive behavioral stress management<br>* Intervention is delivered through Telecare (web based technology) in a group for 60-90 minutes/session. During each session, participants are taught/discuss a new anxiety/arousal reduction technique and focus on stress management. Efficacy of available treatments, disease course, symptom burden, communication with intimate partner and/or family members and health care provider, impact of stress on physical and mental health and symptoms, and management of APC and HT symptoms are used for educational purposes and as catalysts for discussing TCBSM techniques. We allow participants to describe psychosocial stressors with an emphasis on symptoms and disruption, HRQOL and their coping responses for in-session role-plays. Participants are able to access the system at any time to retrieve relaxation and stress management didactics, and contact community resources and other participants in their group.<br>* Other names: T-CBSM;|
| Active Comparator: T-HP<br>Technology based health promotion (control condition) | Behavioral: Technology based health promotion group-based attention matched control condition<br>* Sessions include content from relevant NCI, ACS and other resources developed to address the needs of advanced cancer populations into each topic session. All sessions address APC-specific issues. While men receiving treatment for APC remain interested in general health issues and as they become increasingly aware of the end-of-life issues raised by facing advanced disease, they seem to be interested in making life changes in areas in which they do exercise control (e.g., nutrition), and as such have been integrated into the T-HP modules in addition to general recommendations from sources such as American Heart Association, the NIA and the ACS. T-HP participants are scheduled for weekly group-based health information and promotion sessions (60-90 mins.), which are delivered via our videophones by our T-HP facilitators.<br>* Other names: T-HP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptom burden from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control). | Symptom burden will be measured with the Expanded PC Index Composite (EPIC) | baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3) | 
| Change in HRQOL from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control). | SF-12, a short form version of the commonly used SF-36, a health survey designed to assess multiple dimensions of HRQOL | baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, advanced prostate cancer, technology based