Prostate CancerPC-CHIPNCT03149185
Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
A study testing Technology based cognitive behavioral stress management in people with Prostate Cancer, run by Northwestern University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Technology based cognitive behavioral stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2012to 22 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jesse Brown VA Medical Center
Chicago, Illinois
Rush University Medical Center
Chicago, Illinois
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Technology based cognitive behavioral stress management, Technology based health promotion group-based attention matched control condition
- Keywords
- prostate cancer, advanced prostate cancer, technology based
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology based cognitive behavioral stress managementBehavioural
Also called T-CBSM
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.
Technology based health promotion group-based attention matched control conditionBehavioural
Also called T-HP
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.
| Study group | Role | What they receive |
|---|---|---|
| T-CBSM | Active comparator | Technology based cognitive behavioral stress management. Receives: Behavioral: Technology based cognitive behavioral stress management |
| T-HP | Active comparator | Technology based health promotion (control condition) Receives: Behavioral: Technology based health promotion group-based attention matched control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start25 May 2012
- Primary completion22 Apr 2018
- Study completion22 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149185
- Sponsor's protocol ID
- STU00064136
- Acronym
- PC-CHIP
- Status last verified
- May 2017
- First submitted
- 19 Apr 2017
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benzo RM, Moreno PI, Fox RS, Silvera CA, Walsh EA, Yanez B, Balise RR, Oswald LB, Penedo FJ. Comorbidity burden and health-related quality of life in men with advanced prostate cancer. Support Care Cancer. 2023 Jul 28;31(8):496. doi: 10.1007/s00520-023-07962-6.
PubMed 37501020Walsh EA, Boland CL, Popok PJ, Pedreira PB, Fox RS, Moreno PI, Yanez B, Penedo FJ. Marital status and perceived stress in men with advanced prostate cancer: A randomized-controlled trial of cognitive behavioral stress management. J Psychosom Res. 2023 Apr;167:111198. doi: 10.1016/j.jpsychores.2023.111198. Epub 2023 Feb 16.
PubMed 36812663Walsh EA, Pedreira PB, Moreno PI, Popok PJ, Fox RS, Yanez B, Antoni MH, Penedo FJ. Pain, cancer-related distress, and physical and functional well-being among men with advanced prostate cancer. Support Care Cancer. 2022 Dec 14;31(1):28. doi: 10.1007/s00520-022-07453-0.
PubMed 36515785Penedo 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.
PubMed 31898309Fox 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.
PubMed 31045423
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT03149185
- Acronym / sponsor ID
- PC-CHIP / STU00064136
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, advanced prostate cancer, technology based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 May 2012 (actual)
- Primary completion
- 22 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| T-CBSM | Active comparator | Behavioral: Technology based cognitive behavioral stress managementTechnology based cognitive behavioral stress management. |
| T-HP | Active comparator | Behavioral: Technology based health promotion group-based attention matched control conditionTechnology based health promotion (control condition) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology based cognitive behavioral stress managementAlso: T-CBSMIntervention 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. | Behavioural | T-CBSM |
| Technology based health promotion group-based attention matched control conditionAlso: T-HPSessions 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. | Behavioural | T-HP |
Primary outcome
Change in symptom burden from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).
Time frame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
Symptom burden will be measured with the Expanded PC Index Composite (EPIC)
Change in HRQOL from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).
Time frame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)
SF-12, a short form version of the commonly used SF-36, a health survey designed to assess multiple dimensions of HRQOL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 37501020Benzo RM, Moreno PI, Fox RS, Silvera CA, Walsh EA, Yanez B, Balise RR, Oswald LB, Penedo FJ. Comorbidity burden and health-related quality of life in men with advanced prostate cancer. Support Care Cancer. 2023 Jul 28;31(8):496. doi: 10.1007/s00520-023-07962-6.
- Derived from this study: PubMed 36812663Walsh EA, Boland CL, Popok PJ, Pedreira PB, Fox RS, Moreno PI, Yanez B, Penedo FJ. Marital status and perceived stress in men with advanced prostate cancer: A randomized-controlled trial of cognitive behavioral stress management. J Psychosom Res. 2023 Apr;167:111198. doi: 10.1016/j.jpsychores.2023.111198. Epub 2023 Feb 16.
- Derived from this study: PubMed 36515785Walsh EA, Pedreira PB, Moreno PI, Popok PJ, Fox RS, Yanez B, Antoni MH, Penedo FJ. Pain, cancer-related distress, and physical and functional well-being among men with advanced prostate cancer. Support Care Cancer. 2022 Dec 14;31(1):28. doi: 10.1007/s00520-022-07453-0.
- Derived from this study: PubMed 31898309Penedo 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.
- Derived from this study: PubMed 31045423Fox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology based cognitive behavioral stress management in people with Prostate Cancer, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149185, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.