Introduction
Method
Eligibility criteria
Search strategy
Study selection
Data extraction
Methodological review
Outcomes
Results
Study selection
Risk of Bias
Author | Selection bias | Design | Confounders | Blinding | Withdrawals | Data collection methods | Global rating |
---|---|---|---|---|---|---|---|
Berry (2013) [36] | Moderate | Strong | Strong | Moderate | Strong | Strong | Strong |
Berry (2017) [37] | Moderate | Strong | Strong | Moderate | Moderate | Strong | Strong |
Cathala (2003) [38] | Weak | Weak | n/a | Moderate | Moderate | Weak | Weak |
Davison (2014) [39] | Strong | Moderate | n/a | Moderate | Weak | Strong | Moderate |
Diefenbach (2012) [40] | Moderate | Strong | Weak | Moderate | Moderate | Strong | Moderate |
Fleisher (2015) [41] | Weak | Strong | n/a | Moderate | Moderate | Weak | Weak |
Johnson (2016) [42] | Strong | Moderate | n/a | Moderate | Weak | Weak | Weak |
Kazer (2011) [43] | Weak | Moderate | n/a | Moderate | Moderate | Strong | Moderate |
Lange (2017) [44] | Weak | Moderate | n/a | Moderate | Weak | Weak | Weak |
Osei (2013) [25] | Weak | Strong | Strong | Moderate | Weak | Strong | Weak |
Ruland (2013) [26] | Weak | Strong | Strong | Moderate | Moderate | Strong | Moderate |
Schover (2012) [45] | Weak | Strong | Moderate | Moderate | Strong | Strong | Moderate |
Song (2015) [46] | Weak | Moderate | n/a | Moderate | Strong | Moderate | Moderate |
Viers (2015) [47] | Weak | Strong | Weak | Moderate | Moderate | Moderate | Weak |
Wootten (2015) [48] | Weak | Strong | Strong | Moderate | Moderate | Strong | Moderate |
Yanez (2015) [35] | Weak | Strong | Strong | Moderate | Strong | Strong | Moderate |
Study characteristics
Source (author and year) | Design | Location | Sample characteristics | Feasibility | |||
---|---|---|---|---|---|---|---|
Sample size; age | Disease stage | Treatment info | Recruitment rates | Retention rates | |||
Cathala (2003) [38] | Single group evaluation, post-test only | France (% rural not reported) | n = 140; median: 63 | Localized PC | 100% radical prostatectomy | 28% recruitment rate (140/508)*np | 79% post-study measure (111/140) |
Davison (2014) [39] | Single group, quasi-experimental design | Canada (57% rural) | n = 49; mean 60.5 | Localized PC | No current treatment | 92% (49/53) of patients referred agreed to participate*np | 94% (46/49) follow-up |
Johnson (2016) [42] | Single group, pre/post-test design | USA (% rural not reported) | n = 109; median: 62.5 | Localized PC | No current treatment | 87% (125/143) of men invited completed baseline surveys*np | 87% (109/125) follow-up 26% (33/125) satisfaction survey |
Kazer (2011) [43] | Single subject design | USA (% rural not reported) | n = 9; median: 72 | Localized PC | 100% active surveillance | 45% (9/20) of sample target recruited^nm | 67% (6/9) post-measures |
Lange (2017) [44] | Two group, quasi-experimental design | Germany (26% village, 21% small town, 19% medium town) | Intervention n = 18; median: 60.5; control: n = 16; median: 62.8 | Not reported | 100% prostatectomy | 11% (44/384) recruitment rate over 17 months (aimed for 120)^nm | 31% (44/143) post-measures |
Song (2015) [46] | Single group, pre/post-test design | USA (% rural not reported) | n = 26 couples; mean: 63 (PC) | Localized PC | 41% surgery (type not specified) 59% radiotherapy | 51% recruitment rate (26/51)*np | 85% (22/26) post-intervention |
Berry (2013) [36] | 2-arm RCT | USA “Urban” (% rural not reported) | Intervention n = 266; median: 63 control: n = 228; median: 62 | Localized PC | No current treatment | 68% response rate (494/724)^nm | 91% intervention vs. 87% control |
Berry (2017) [37] | 2-arm RCT | USA “Urban” (% rural not reported) | Intervention n = 198; 69.6% aged ≥ 60 years control n = 194; 66.7% aged ≥ 60 years | Localized PC | No current treatment | 70.8% response rate (392/554)#m | 76% (152/198) intervention vs. 79% (153/194) control |
Diefenbach (2012) [40] | 3-arm RCT | USA “Urban” (% rural not reported) | Interventions T-PIES: n = 32; mean: 60 NT-PIES: n = 21; mean: 63 control: n = 19; mean: 64 | Localized PC | No current treatment | 75% (91/121) eligible men agreed to participate*np | 79% (72/91) post-measures |
Fleisher (2015) [41] | 2-arm RCT | USA (% rural not reported) | Project 1: (PC only) n = 439; mean: 65 | Localized PC | No current treatment | 61% (n = 439) of accrual target met^nm | 77% (339/439) follow-up |
Osei (2013) [25] | 2-arm RCT | USA (% rural not reported) | Intervention: n = 20; control n = 20; overall mean: 67 | Not reported | Not reported | 5% response rate (51/1000) for expressions of interest*np | 100% post-intervention |
Ruland (2013) [26] | 2-arm RCT | Norway (% rural not reported) | Intervention: n = 162 (96 breast and 66 prostate); mean: 57 control: n = 163 (93 breast and 70 prostate); mean: 56 | 10–12% metastatic disease*not PC specific | 8% prostatectomy 26% radiotherapy 48% hormone therapy | Unknown response rate. 445 people expressed interest and 325 (73%) consented and randomized#m | Overall 77% intervention vs. 84% control group PC only 83% intervention vs. 84% control 81% PC survivors at 12 months |
Schover (2012) [45] | 3-arm RCT | USA “Urban” (% rural not reported) | Interventions FF: n = 60 couples; mean: 64 WEB1: n = 41 couples; mean: 64 WEB2: n = 71 couples; mean: 64 Waitlist control n = 48, then randomized to FF (n = 20) or WEB1 (n = 22) | Localized PC | 74% radical prostatectomy 26% radiotherapy | Unknown response rate, no pre-specified sample size*np | 72% FF vs. 87% WEB1 vs. 83% WEB2 post-intervention 93% FF vs. 83% WEB1 vs. 73% WEB2 follow-up 9% drop-out in WL group during 3 month waiting period. |
Viers (2015) [47] | 2-arm RCT | USA (% rural not reported) | Intervention VV: n = 34; mean: 62.5* OV (control): n = 36; mean: 61.5** those having completed post measures | Not reported | 100% radical prostatectomy | 31% (70/225) of group initially contacted randomized #m | 79% (55/70) follow-up |
Wooten (2015) [48] | 3-arm RCT | Australia (15–18% inner regional) | Interventions MRA only: n = 47; MRA + Forum: n = 48; Forum only (control): n = 47; overall mean: 61 | Localized PC | 86% radical prostatectomy 13% EBRT 6% hormone therapy (in conjunction with RT) | 95% (142/150) of recruitment target met ^nm | 87% midweek follow-up 73% post-intervention 66% 3-month follow-up [60] 51% 6-month follow-up [60] |
Yanez (2015) [35] | 2-arm RCT | USA “Urban” (% rural not reported) | Intervention n = 37; control n = 37 Overall mean: 69 | 49% advanced 51% metastatic | 100% on ADT | 13% (74/240) of recruitment rate target met^nm | 86% intervention vs. 86% control follow-up |
Intervention characteristics
Feasibility and acceptability
Source (author and year) | Objectives and description of intervention | Engagement (usage) | Acceptability (satisfaction) | Conclusions |
---|---|---|---|---|
Cathala (2003) [38] | Objective: test and evaluate online medical file in lieu of face-to-face visit Participants could login to the EHR to view various hospital reports. They could view videos and read information regarding their operation and condition. They could complete sections that allowed them to track their PSA levels and their QoL over time. Any new entries would trigger an email to the chosen physician. | First 6 months tracked by the “connection report system” 95% regularly looked at the site 8 (mean) connections per patient (range 1–22): 2 dialogue zone messages 2 PSA entries 4 QoL surveys | 98% satisfied with various site sections 94% satisfied with medical file 11% had problems accessing the site 14% reported technical problems | The online medical program approach was determined to be useful and acceptable for those patients requiring regular follow up. It overcame geographical barriers and allowed close contact between patients and health professionals, while also allowing physicians access to medical files. |
Davison (2014) [39] | Objective: to prepare and identify treatment preferences and reduce decisional conflict during selection of PC treatment. Participants used an online decisional aid to produce a summary page intended to be presented to a clinician before treatment begins. The summary identified their personal preferences around decisional control, type and amount of information wanted, factors influencing their decision, and their preliminary treatment choice. | 61% shared summary sheet with a health care worker involved in care: 35% with urologist 14% radiation oncologist 12% with family doctor 47% with nurse educator | Patients satisfied with amount of information (96%), type of information (93%), way delivered (89%), involvement in decision (91%), and treatment choice (96%) Participants that shared summary with their HCP were significantly more satisfied with the usefulness of the sheet. | The use of this support aid was found to be acceptable to patients, for use at home or in clinic. This can assist men with localized PC to identify the factors having an influence on their treatment decision and provides a means for these men to share these preferences and values with their physician at the time of treatment discussions. This simple tool could also easily be incorporated into clinical practice in order to guide treatment discussions provided by oncology nurses to the patient group. |
Johnson (2016) [42] | Objective: to support patients with shared decision-making and reduce decisional conflict for men with newly diagnosed LPC prior to treatment decision. WiserCare was a web-based application that provides education, preference measurement and personalized decision analysis. A report was generated that was included in the patient file to be reviewed by clinicians before consultation. | 76% of men invited voluntarily completed the decision support module 125 patients who clicked on the link completed the module. 109 (87%) completed the module and the follow-up survey | 82% mostly satisfied or delighted with quality of care 97% mostly satisfied or delighted with explanations of treatment and procedures 97% mostly satisfied or delighted with helpfulness of information | Implementation of the WiserCare application was found to be feasible and improved several important components of decision quality for men deciding on treatment for newly diagnosed LPC. Compared to similar patients who did not participate in WiserCare, patients who completed this decision aid felt more included in and jointly responsible for their treatment decisions, and strongly agreed that treatment decisions were discussed in detail by their provider. |
Kazer (2011) [43] | Objective: to support patients to improve knowledge and self-efficacy, and reduce uncertainty during AS for PC. Intervention delivered (a) general information about PC and AS; (b) cognitive reframing strategies; (c) self-care management strategies; and (d) tailored email-based interventions specific to the needs of each participant. | Average 20 website views per participant (range 2–40). | 4.2 out of 5 for overall satisfaction of website and information | The study findings showed positive trends in acceptability of the trial. A larger clinical trial is planned to follow this pilot. |
Lange (2017) [44] | Objective: to support mental health (e.g. reduce distress and improve QoL) in PC survivors. Participated in 5 group-based online chat sessions (60–90 min each, once per week over 5 weeks) led by a certified psychotherapist with experience in psycho-oncology. Each session had a theme proposed by the therapist but open interaction among participants was also encouraged. | 100% of intervention group completed the evaluation session No report of participant engagement with chat groups The frequency and duration of sessions was “sufficient” (scores of 2.06 each). “Lack of interest” (31%) and “doubting that it could help me” (31%) were the most frequent reasons for non-participation | Overall positive evaluation of program (1 = strongly agree; 5 = strongly disagree) 2.44/5 – overall satisfaction with chat program 2.61/5 – therapist helpful 4.39/5 – had problems with chat program 3.95/5 – had computer problems during chat | The study findings indicate that web based chat groups may not be an effective way to decrease PC perceived distress despite apparent user acceptance of the intervention. Study highlighted the difficulty in recruitment and engagement of patients even in a major prostate cancer center. |
Song (2015) [46] | Objective: to support patients’ knowledge of symptom management, communication skills, and improve QoL in LPC post-treatment patients. Couples were provided seven education modules to review (two were mandatory, and five were optional). Mandatory modules provided information about how couples can work as a team (e.g., communication) and survivorship issues. Optional modules focused on the management of PC-specific symptoms and general symptoms. | No report of participant engagement in mandatory modules. Average number of logins: 2.73 per patient Average total time spent on PERC intervention was 41.99 min Optional modules completed: 77% sexual dysfunction 77% fatigue 76% urinary dysfunction | Overall positive evaluation of program (1 = strongly disagree; 5 = strongly agree) 4.41/5 website easy to use 4.14/5 website was interesting and engaging 3.09/5 satisfied with quality of information | The study found the intervention (PERC) was a feasible and acceptable method of reducing side effects of PC treatment-related symptoms and improving QoL. Addition, participants rated PERC as easy to use and understand, and they found it to be engaging, high quality, and relevant. High usage rates were encouraging, particularly as PERC targeted older adults (with traditionally poor technology literacy). This method may be useful for overcoming geographical barriers and improving the convenience of information access for patients. |
Berry (2013) [36] | Objective: reduce uncertainty and decisional conflict during selection of PC treatment. The intervention was a treatment decision aid tool with tailored information based on important identified personal factors, age, race and ethnicity, decisional control preferences, and symptoms. Participants spend time on the site, engaging with the education and assessments. Pre- and post-questionnaires are minimal. Baseline session involved surveys to determine personal preferences, factors, symptoms, decisional conflict, etc. Once complete, participants were randomized to one of two groups by an algorithm embedded in the software. P3P is composed of education and communication coaching. This takes the form of text, graphs, video clips, infographics, etc. Tailored to personally relevant factors assessed at baseline. For example, if a participant indicated sexual health a priority then this would be one of the first topics discussed. Post-measures 1-month later were completed via email or mail; whichever was preferred. DC was assessed again. | Time to complete average 46 min (range 16 to 69 min) [50] | (Higher score = more positive) [50] 4.1/5 overall satisfaction 4.8/5 easy to use 4.7/5 understandability 4.0/5 helpfulness of program 4.0/5 enjoy program 3.7/5 value of information Current study: 3.7/5 average usefulness | P3P is a useable and acceptable decision support system that can be deployed in a clinical setting [50] P3P did not result in higher preparation for decision making at 1 month. Satisfaction with decision was not associated with intervention use at 6 months [51]. |
Berry (2017) [37] | Objective: reduce uncertainty and decisional conflict during selection of PC treatment. Updated from Berry (2013) [36] to be more appropriate for lower literacy levels. | Pilot study [59] used eye tracking to determine “time to first fixation” and “total visit duration” in mean seconds on various aspects of the page (n = 12). Time to first fixation: M (SD) Text “understanding statistics” 8.9 (19.5) Text: YTL 24.1 (19.4) Infographic 41 (97.9) Total visit duration: M (SD) Text “understanding statistics” 39.7 (32.9) Text: YTL 53.8 (31.7) Infographic 21.7 (13.7) | (Higher score = more positive) [59] 4.8/5 ease of use 4.5/5 enjoyment 4.7/5 helpfulness 4.7/5 satisfaction 4.6/5 amount of time acceptable 4.9/5 understandable 4.5/5 usefulness of info | This aid to shared decision-making may be helpful to support men recently diagnosed with LPC. |
Diefenbach (2012) [40] | Objective: to support patients to improve knowledge of treatments, side effects, self-efficacy, and QoL, and reduce uncertainty during AS for PC. T-PIES: participants were presented information according to their preferred monitoring style (high vs. low). Education was available via the library, and they could ask questions to a clinician and participate in a support group. They could also fill out a decision-making assessment if they wanted. NT-PIES: participants had access to the PIES system as above but written information was not tailored to the monitoring preferences of the user. | 79% (72/91) completed post measures | Total sample (higher score = more positive) 4.15/5 useful information 4.15/5 satisfactory information 1.48/5 confusing information UC more likely to report: information was confusing (p = .05) too voluminous (p = .01), made them more anxious (less helpful p = .01; calmed nerves p = .04). Intervention groups only (no sig differences between intervention groups) (5 = strongly agree) 3.76/5 information clearly presented 3.46/5 includes everything I need 2.57/5 more information than I want 4.04/5 graphics clear 3.87/5 glossary helpful 3.80/5 library easy to understand 3.98/5 library useful | The implementation of PIES within a clinical practice was found to be feasible and acceptable to patients recently diagnosed with prostate cancer. |
Fleisher (2015) [41] | Objective: to support patients to improve knowledge of treatments, side effects, and promote informed decision-making for newly-diagnosed PC patients. The intervention consisted of four modules: Library – text-based information on a variety of relevant topics (e.g., what is prostate cancer, treatment options, clinical trials). Patient stories – multi-media testimonials with actual patients were used and presented either with video or still photographs with voice-overs focusing on relevant issues, including treatment choices, side-effects, and emotional reactions. Doctor’s office – video-based and text-based information on cancer specific topics and FAQs as well as video demonstrations of how to communicate with providers using an evidence-based communication approach. Notebook – interactive values clarification tool where patients could list the pros and cons of each treatment approach and rank in terms of personal values. | 96% in intervention group read the print materials 57% used the website and/or CD-ROM, of which: 54% used the website only 24% used CD-ROM only 22% used both 79% of website/CD-ROM users, reported using the V-CIS for an hour or more Participants who reported not using the V-CIS: 21% reported “no time” or “too busy” 25% said it was “not needed” 41% had technical problems Objective usage n = 32 (44%) 59% logged on more than once 96% accessed the library 50% accessed the patient story 59% accessed the doctors’ office 40.6% accessed the notebook Average overall time spent was 70.9 min (SD = 67.6) | Overall satisfaction (1 = strongly agree; 4 = strongly disagree) * significant differences across projects 1.69/5 increased knowledge⁎ 1.80/5 helped me talk to my doctor⁎ 2.01/5 helped with emotional concerns 2.98/5 made me feel more anxious⁎ 1.84/5 made me feel more confident⁎ 1.87/5 helped make treatment decisions⁎ 1.76/5 information helped me deal with cancer treatment⁎ 1.99/5 information helped me deal with side effects 2.25/5 helped me deal with emotional concerns of recurrence 2.18/5 helped me adjust to life after treatment 2.06/5 helped me understand my follow-up care | Feedback from VCIS users indicated that it significantly increased their self-reported knowledge, helped them to talk with their doctor, lower anxiety and increase confidence, and helped make treatment decisions. Cancer patients value both print and eHealth interventions. Barriers to adoption and usage remain, such as lack of perceived need and issues with technology. |
Osei (2013) [25] | Objective: to support and improve patients’ knowledge (of treatments and side effects) and QoL in patients diagnosed with PC. Intervention utilized the online education and support group - Us TOO International Web site. Participants were asked to participate in the group at least three times per week for 6 weeks. | Study did not report actual usage. Participation was not defined therefore it is unclear whether men had to comment, post, or just read/view educational material to be considered participating. | Overall program satisfaction (4-point scale) Quality of services 75% good or excellent Received type of services wanted 89% generally/definitely Needs were met 21% all needs met, 37% most needs met 3.01/4 overall satisfaction Four men made statements about the need for other prostate cancer patients to get this information. | It is unknown as to the effectiveness of online vs. face-to-face groups, whether online support is contraindicated based on specific patient psychosocial characteristics, and the role that physicians play in effectiveness based on their recommendation. |
Ruland (2013) [26] | Objective: to support and improve patients’ knowledge and QoL, and lower symptom distress in patients diagnosed with PC. Participants were given access to WebChoice online intervention which included: - assessment component - tailored symptom self- management support - information section - communication section (forum and Q&A with nurse) - personal diary Participants were told that they could use WebChoice as often they liked during their 1-year study participation and that use of the system was entirely voluntary. | Activity log tracked server details by ID for participants. 2 reports were generated; usage and user report. Usage – within specific period of time: logins, section visits, total visit duration, messages sent, and forum posts. User – patient use of the system: section visits, number of assessments, number of messages sent, posts, and diary notes. PCS (n = 47/66) logged on at least twice were categorized as “users” [57] Users used the site 2018 times (median = 10.0; range 2–593 logons). Number of visits to sections (median) Discussion forum: 1409 (4.0) Message to nurse: 624 (4.0) Assessments: 622 (5.0) Self-management support: 348 (5.0) Information section: 271 (3.0) Diary: 308 (2.0) | A Likert scale from 1 (not at all useful) to 9 (highly useful) was used to evaluate the usefulness of information given to patients. PC specific data was not provided. [57] How useful Self-management interventions 6.1 (1.9) General information 6.5 (1.7) Discussion forum 6.4 (1.7) Answer from nurse 7.6 (1.6) Of what quality Self-management interventions 6.5 (1.6) General information 6.8 (1.6) Discussion forum 6.7 (1.5) Answer from nurse 7.6 (1.6) How easy to understand Self-management interventions 7.3 (1.5) General information 7.2 (1.4) Discussion forum 7.6 (1.4) Answer from nurse 8.1 (1.3) | The study found WebChoice to be a promising tool to help cancer patients better manage their illness and reduce symptom distress. |
Schover (2012) [45] | Objective: to support and improve patients’ knowledge of and manage symptoms of erectile dysfunction, and improve sexual satisfaction in PC survivors. The intervention consisted of sexual counseling. Couples were randomized adaptively to a 3-month WL, a 3-session face-to-face format (FF), or an Internet-based format (WEB1). A second Internet-based group (WEB2) was added to examine the relation between web site use and outcomes. 3 homework reports required in each condition. | 52% of men and 44% of partners completed > 75% of the web site Participants asked to engage in the site or attend 3 FF sessions over 12 weeks. Unknown homework report completion rate. | No measures of satisfaction were included. | The study found the Internet-based sexual counseling program for couples to be as effective as a brief traditional sex therapy format in producing persistent improvements in sexual outcomes after prostate cancer. The time required for therapists to respond to emails was significantly shorter than time required to conduct traditional therapy sessions, suggesting Internet-based interventions may be more time- and cost-effective as well as accessible to patients. |
Viers (2015) [47] | Objective: to replace traditional patient visits and improve cost, efficiency and patient satisfaction in PC patients post-prostatectomy. VV from home or work with urologist. A mail-in PSA test was completed locally before the appointment. Patients were evaluated by a resident or midlevel provider and a staff urologist. If a physical examination was indicated, a follow-up clinic appointment was provided. | 82% of those randomized to video appointment completed it. | No significant difference in patient satisfaction between the intervention (remote visits) and control (office visits) groups. “I was pleased with the quality of the medical encounter” 83%/91% strongly agree intervention/control (p = .41) “I believe that the medical encounter was conducted in a confidential manner” 88%/100% strongly agree intervention/control (p = .09) “I was overall satisfied with appointment today” 88%/91% strongly agree intervention/control (p = .70) | The majority (96%) of patients undergoing VV would participate in this type of encounter again. For established patients, this model could be applied across multiple urologic indications and clinical scenarios. VV timings improved across all measures throughout the course of the trial, with only two technical failures early in the study. Funding and credentialing limited the size of the study population. ~70% of physicians reported that credentialing is a significant setback to the implementation of telemedicine. |
Wooten (2015) [48] | Objective: to support patients to improve their knowledge and reduce psychological distress in LPC patients undergoing treatment. Self-directed CBT-based intervention provided psycho-education, a series of interactive exercises and regular feedback. Intervention was a 6-module online program for participants to work through at their own pace over 10 weeks. The six modules focused on: 1. The emotional impact of prostate cancer 2. Cognitive strategies and effective communication 3. Coping with the physical challenges relating to prostate cancer 4. Sexuality and masculinity 5. Sexuality and intimacy 6. Planning for the future | 59% (mean) content completed MRA only group = 60% MRA + forum group = 57% Completion rates dropped as participants moved through modules. On average participants completed: 87% module 1, 72% module 2, 60% module 3, 56% module 4, 41% module 5, 36% of module 6 Forum participation was higher for Forum alone group (avg. 2–3 posts per user) than MRA + forum (avg. 1–2 post per user) 69% of participants reported spending < 30 min per week on the forum. | Overall satisfaction n = 26 [61] 48% satisfied with intervention 78% would recommend Forum satisfaction 41% satisfied with forum 66% said easy to use 38% said other men’s posts were helpful 31% said moderator posts were useful As a result of these findings and qualitative feedback from users and technical consultants, changes were implemented in the larger included study. However, satisfaction results have yet to be published. | The intervention was received positively by participants in the pilot study. Feedback indicated good acceptability of the intervention. Some technical and participant engagement issues were identified and changes were implemented as a result of the pilot testing. The included study highlights the potential to deliver support for men with PC. |
Yanez (2015) [35] | Objective: to support patients to ease their symptom burden and improve QoL in advanced PC patients. Intervention delivered via a web-based platform on a tablet by a group facilitator with video conferencing software. Intervention aims included developing stress awareness, learning stress reduction skills, changing negative stressor appraisals, developing coping skills, building interpersonal skills, and building or enhancing social networks. The website contained review materials of the principles of cognitive behavioral stress management (discussed during the weekly group meetings), as well as audio recording of relaxation strategies (e.g., guided imagery) that participants were encouraged to review and practice on a weekly basis. | CBSM-intervention group attended 6.59/10 sessions (SD = 3.35) HP-control group completed 8.22/10 (2.75) sessions CBSM-intervention group completed 4.84 (3.35) weekly assessments HP-control group completed 7.05 (3.14) weekly assessments During the first 30 min of each group session, CBSM participants practiced a new stress reduction/relaxation technique. During the last 60 min, the focus was on stress management. | No between group difference in exit survey scores (4-items). 4-point scale (higher numbers = more positive) Questions: mean (SD) In general, how much did you like the information presented in the weekly online reviews? CBSM: 3.65 (0.49) HP: 3.40 (0.76) In general, how much did you like the information presented in the online expert videos? CBSM: 3.66 (0.50) HP: 3.46 (0.52) In general, how much did you like the weekly online groups? CBSM: 3.40 (0.83) HP: 3.68 (0.69) In general, how much did you like the online relaxation exercises? CBSM: 3.81 (0.40) HP: N/A | Findings generally support the feasibility, acceptability and preliminary efficacy of this CBSM psychosocial intervention for men with advanced prostate cancer. Participants in HP condition were more likely to attend study sessions than participants in the CBSM condition. |
Efficacy
Source | Design | Outcomes measured | Efficacy results | Conclusions |
---|---|---|---|---|
Berry (2013) [36] | 2-arm RCT (n = 494) Decision aid tool vs attention control. Attention control given a list of reputable websites to review in the same time period as the intervention group. | Primary: decisional conflict subscales including: uncertainty, informed, values clarity, and support. Secondary: PC with decision at 6 months completed effective decision and total score. | Primary • Significantly less uncertainty (p = .04) and lack of values clarity (p = .002) in intervention group. • Subscales effect sizes: uncertainty: − 3.61 (− 7.01, − 0.22); lack of values clarity: − 3.57 (− 5.85, − 1.30) Secondary • No difference in total DC score between groups (p = .07). • Estimation of group study effect (coefficient (95%CI)): Total score − 1.75 (− 3.61,0.11); p = .07 | Findings support efficacy of the P3P intervention for addressing uncertainty and facilitating selection of a treatment. P3P did not result in higher preparation for decision making at 1 month. Satisfaction with Decision was not associated with intervention use at 6 months [51]. |
Berry (2017) [37] | 2-arm RCT (n = 392) Decision aid tool vs. attention control. Attention control given a list of reputable websites to review in the same time period as the intervention group. Decision aid updated from Berry (2013) to be more appropriate for lower literacy levels. | Primary: total score on modified low literacy decisional conflict scale (reported at baseline and 1 month) | Multivariate model: (LS mean (95%CI); p) • P3P vs. control: − 5.0 (− 9.40, − 0.59); p = .003 • Lower income: 8.69 (4.43, 12.96); p < .0001 • Having made no decision at 1 month: 20.11 (16.10, 24.13); p < .0001 • Lower D’Amico risk: 4.29 (0.80, 7.78); p = .02 Had ≥ 2 consults: 6.04 (1.83, 10.26); p = .0005 • EUH site: 11.02 (3.49, 18.56); p = .02• Interactions: Marginal significance for group and marital status (p = .06) with single men in P3P having lower DC. Marginal significance for number of consults by group (p = .07) with those in control group having < 2 consults having higher DC scores. | P3P demonstrated a beneficial effect for men with LPC in a multi-institutional sample as they engaged in decision-making for the management of the cancer. Other variables impacted conflict and modified P3P’s effect, notably risk level and men’s resources. |
Diefenbach (2012) [40] | 3-arm RCT (n = 72) T-PIES vs. NT-PIES vs. UC. T-PIES: information given according to preferred style of monitoring, and opportunity to ask clinicians, and a support group. NT-PIES: as above but written information not tailored to monitoring preferences. UC: attention control given NCI brochures to read in the same period as the intervention groups. | Primary: treatment decisional measures Secondary: psychological distress, treatment preferences | No difference between T-PIES vs. NT-PIES therefore PIES groups were combined for these comparisons vs control. PIES groups were significantly more confident in their treatment decision vs control. (Mean (SD): higher score better) UC: 3.22 (1.32) vs. PIES: 3.85 (1.022); p = .02 PIES groups less likely to report needing more information vs control. (Mean (SD): lower score better): UC: 3.44 (1.54) vs. PIES: 2.52 (1.49); p = .02 3 groups analyzed: UC vs. T-PIES vs. NT-PIES Helpful in decision-making (higher is better) UC: 1.79 (0.92) vs. T-PIES: 4.29 (0.64) vs. NT-PIES: 4.10 (1.07); p = .01 Calmed nerves about decision (higher is better) UC: 2.68 (1.06) vs. T-PIES: 3.12 (0.83) vs. NT-PIES: 3.46 (0.89); p = .04 Made more anxious about decision (lower is better) UC: 3.62 (1.05) vs. T-PIES: 2.45 (1.09) vs. NT-PIES: 2.40 (1.27); p = .03 | PIES improved key decision-making process variables (e.g., knowledge of treatments and side effects), as well as increasing confidence in and reducing the emotional impact of a treatment decision making. No additional benefit to tailoring information to delivery style in the two intervention groups. |
Osei (2013) [25] | 2-arm RCT (n = 40) Online education and support group - Us TOO International Web site. Control group was given PC resource kits. Participants were asked to participate in the group at least three times per week for 6 weeks. | Primary: QoL (general and cancer specific, life satisfaction, relationship satisfaction) Secondary: prostate cancer-specific symptoms | MANOVAs mean differences across time No statistically significant effects of age and/or group but there was a significant (p = .036) time*group interaction across all ten measures included in a global QoL measure uniquely constructed for this study. Trend was for a drop in QoL at midpoint measure (6 weeks) with a return to initial levels at post measure. Variables affected included: perceived physical health (p < 0.001) urinary irritation and obstruction health (p < 0.019) sexual health (p < 0.001) hormonal health (p < 0.001) life satisfaction (p < 0.001) spouse negative characteristics (p < 0.030) | The results suggest that online support groups can have a positive effect on perceived QoL of men. |
Ruland (2013) [26] | 2-arm RCT (n = 325 overall; 136 PC) Intervention group (WebChoice users) vs. control (URLs of reputable websites) | Primary: symptom distress Secondary: depression, self-efficacy, health-related QoL, social support | Note: efficacy outcomes were not reported separately for breast vs. PC survivors. Reporting when applicable: slope estimate (95%CI); t; p • No between group difference in overall MSAS-SF score (p = .19) • No between group difference in psychological symptoms scale (p = .11) or physical symptoms scale (p = .09) • Significant between group difference in GDI: − 0.059; (− 0.101, − 0.004); t = 4.42; p = .037 • Within-group improvements in depression for intervention group: − 0.41; (− 0.71, − 0.11); t = − 2.71; p = .007 • Within group decrease in self-efficacy for control group: − 3.77; (− 6.38, − 1.15); t = − 2.82; p = .005) • Within group decrease in health-related QoL for control group: − 0.01; (− 0.01, − 0.00); t = − 2.77; p = .006 | That WebChoice is a promising tool to help cancer patients better manage their illness and reduce symptom distress, is partially supported by the data. The secondary outcome measures did not show significant differences between study groups with respect to depression, self-efficacy, health-related QoL, and social support, however the benefits of WebChoice were still quite respectable. High use of symptom assessments, advice, and the discussion forum was associated with high levels of symptom distress [52]. |
Schover (2012) [45] | 3-arm RCT (n = 182) 3-month waitlist (WL) vs. 3-session face-to-face format (FF) vs. 3 session internet-based format (WEB1). A second internet-based group (WEB2) was added. | Primary: erectile function for PC; female sexual function for partners. Secondary: emotional distress, relationship satisfaction | No significant changes in outcome measures during WL period Significant gains in IIEF for all men between baseline and 6 months (p < .0006) and 1-year (p < .0046) follow-up for erectile function. IIEF scores: p value, Cohen d: • FF across time p < .0001, d = 0.35 • WEB1 across time p = .004, d = 0.35 • WEB2 across time p = .0096, d = 0.27 No difference between groups (FF vs. WEB1 vs. WEB2) at follow-up for erectile function. | The internet-based sexual counseling program was found to be as effective as traditional face-to-face counseling for improving sexual outcomes in prostate cancer survivors. |
Viers (2015) [47] | 2-arm RCT (n = 70) Remote video visits (VV) from home or work with urologist vs. traditional office visits (OV). | Primary: visit efficiency (measured by time) Secondary: patient/provider satisfaction, cost of visits | No difference between groups in (VV mean vs. OV mean; (95% CI); p): • Total time in minutes devoted to patient care: 17.9 vs. 17.8; (− 5.9, 5.6); p = .97 • Total patient face time in minutes: 14.5 vs. 14.3; (− 5.4, 5.2); p = .96 • Patient–staff face time in minutes: 12.1 vs. 11.8; (− 4.2, 3.5); p = .85 • Patient waiting time in minutes: 18.4 vs 13.0, (− 13.7, 3.0); p = .20 Linear regression analysis of timing data revealed a downward trend in timing parameters for the VV arm, however, not statistically significant (p = 0.07) VV group had significantly lower estimated costs including (all p < 0.0001): • distance traveled (median 0 vs. 95 miles) • travel time (0 vs. 95 min) • work missed (0 vs. 1 day) • money spent ($0 vs. $48) | VVs had equivalent timing efficiency, similar patient satisfaction, and significantly reduced costs when compared to OVs. Specifically, VVs were associated with reductions in distance traveled, travel time, missed work, and money spent. A learning curve for the use of VV is present, but further investigations are needed. |
Wooten (2015) [48] | 3-arm RCT (n = 142) MRA only vs. MRA+ forum vs. forum only | Primary: psychological distress (DASS-21) Secondary: prostate cancer-related QoL, confidence | Pairwise comparisons • Psychological distress: MRA + forum (↓) vs. forum only (↑): − 8.8 (− 16.7, − 0.9); p = 0.02 • Informed decision: MRA only (↑) vs. MRA + forum (↓):15.3 (0.8, 29.8); p = 0.03 • Regret: MRA + forum (↓) vs. Forum only (↑): − 8.1 (− 16.1, − 0.1); p = 0.04 • Outlook: MRA only (↑) vs. Forum groups (↓): 17.2 (2.9, 31.4); p = 0.01 | A statistically and clinically significant improvement in psychological distress was seen for participants who had access to both the online intervention and moderated forum, while no significant change in psychological distress was seen for the other two intervention conditions. |
Yanez (2015) [35] | 2-arm RCT (n = 74) CBSM (cognitive-behavioral stress management) intervention vs. health promotion attention control | Acceptability (main outcome detailed in Table 3) Secondary: cancer-related distress (IES-R), depressive symptoms, health-related QoL | CBSM mean vs. HP mean; p Completers Cancer-related distress: 8.39 vs. 10.20; p = .48 Depression: 43.37 vs. 47.29; p = .03 FACT total: 88.32 vs. 84.03; p = .17 Intention-to-treat Cancer-related distress: 8.46 vs. 9.86; p = .56 Depression: 44.04 vs. 47.13; p = .06 FACT total: 87.95 vs. 85.39; p = .39 | Participants in HP condition were more likely to attend study sessions than participants in the CBSM condition. Although the sample size was underpowered effect sizes suggest the CBSM may have contributed to reduce depression more and reduce QoL more than control. |