| Literature DB >> 30610736 |
Cynthia C Forbes1,2, Amy Finlay3, Megan McIntosh3, Shihab Siddiquee4, Camille E Short3.
Abstract
PURPOSE: To examine the feasibility, acceptability, and efficacy of online supportive care interventions targeting prostate cancer survivors (PCS).Entities:
Keywords: Cancer care; Cancer services; Digital health; Men’s health; Well-being
Mesh:
Year: 2019 PMID: 30610736 PMCID: PMC6394465 DOI: 10.1007/s11764-018-0729-1
Source DB: PubMed Journal: J Cancer Surviv ISSN: 1932-2259 Impact factor: 4.442
Fig. 1Prisma flow diagram
Risk of bias assessment summary
| Author | Selection bias | Design | Confounders | Blinding | Withdrawals | Data collection methods | Global rating |
|---|---|---|---|---|---|---|---|
| Berry (2013) [ | Moderate | Strong | Strong | Moderate | Strong | Strong | Strong |
| Berry (2017) [ | Moderate | Strong | Strong | Moderate | Moderate | Strong | Strong |
| Cathala (2003) [ | Weak | Weak | n/a | Moderate | Moderate | Weak | Weak |
| Davison (2014) [ | Strong | Moderate | n/a | Moderate | Weak | Strong | Moderate |
| Diefenbach (2012) [ | Moderate | Strong | Weak | Moderate | Moderate | Strong | Moderate |
| Fleisher (2015) [ | Weak | Strong | n/a | Moderate | Moderate | Weak | Weak |
| Johnson (2016) [ | Strong | Moderate | n/a | Moderate | Weak | Weak | Weak |
| Kazer (2011) [ | Weak | Moderate | n/a | Moderate | Moderate | Strong | Moderate |
| Lange (2017) [ | Weak | Moderate | n/a | Moderate | Weak | Weak | Weak |
| Osei (2013) [ | Weak | Strong | Strong | Moderate | Weak | Strong | Weak |
| Ruland (2013) [ | Weak | Strong | Strong | Moderate | Moderate | Strong | Moderate |
| Schover (2012) [ | Weak | Strong | Moderate | Moderate | Strong | Strong | Moderate |
| Song (2015) [ | Weak | Moderate | n/a | Moderate | Strong | Moderate | Moderate |
| Viers (2015) [ | Weak | Strong | Weak | Moderate | Moderate | Moderate | Weak |
| Wootten (2015) [ | Weak | Strong | Strong | Moderate | Moderate | Strong | Moderate |
| Yanez (2015) [ | Weak | Strong | Strong | Moderate | Strong | Strong | Moderate |
Description of study characteristics
| Source (author and year) | Design | Location | Sample characteristics | Feasibility | |||
|---|---|---|---|---|---|---|---|
| Sample size; age | Disease stage | Treatment info | Recruitment rates | Retention rates | |||
| Cathala (2003) [ | Single group evaluation, post-test only | France (% rural not reported) | Localized PC | 100% radical prostatectomy | 28% recruitment rate (140/508)*np | 79% post-study measure (111/140) | |
| Davison (2014) [ | Single group, quasi-experimental design | Canada (57% rural) | Localized PC | No current treatment | 92% (49/53) of patients referred agreed to participate*np | 94% (46/49) follow-up | |
| Johnson (2016) [ | Single group, pre/post-test design | USA (% rural not reported) | 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) [ | Single subject design | USA (% rural not reported) | Localized PC | 100% active surveillance | 45% (9/20) of sample target recruited^nm | 67% (6/9) post-measures | |
| Lange (2017) [ | Two group, quasi-experimental design | Germany (26% village, 21% small town, 19% medium town) | Intervention | Not reported | 100% prostatectomy | 11% (44/384) recruitment rate over 17 months (aimed for 120)^nm | 31% (44/143) post-measures |
| Song (2015) [ | Single group, pre/post-test design | USA (% rural not reported) | Localized PC | 41% surgery (type not specified) 59% radiotherapy | 51% recruitment rate (26/51)*np | 85% (22/26) post-intervention | |
| Berry (2013) [ | 2-arm RCT | USA “Urban” (% rural not reported) | Intervention | Localized PC | No current treatment | 68% response rate (494/724)^nm | 91% intervention vs. 87% control |
| Berry (2017) [ | 2-arm RCT | USA “Urban” (% rural not reported) | Intervention | Localized PC | No current treatment | 70.8% response rate (392/554)#m | 76% (152/198) intervention vs. 79% (153/194) control |
| Diefenbach (2012) [ | 3-arm RCT | USA “Urban” (% rural not reported) | Interventions T-PIES: | Localized PC | No current treatment | 75% (91/121) eligible men agreed to participate*np | 79% (72/91) post-measures |
| Fleisher (2015) [ | 2-arm RCT | USA (% rural not reported) | Project 1: (PC only) | Localized PC | No current treatment | 61% ( | 77% (339/439) follow-up |
| Osei (2013) [ | 2-arm RCT | USA (% rural not reported) | Intervention: | Not reported | Not reported | 5% response rate (51/1000) for expressions of interest*np | 100% post-intervention |
| Ruland (2013) [ | 2-arm RCT | Norway (% rural not reported) | Intervention: | 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) [ | 3-arm RCT | USA “Urban” (% rural not reported) | Interventions FF: | Localized PC | 74% radical prostatectomy | 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) [ | 2-arm RCT | USA (% rural not reported) | Intervention VV: | Not reported | 100% radical prostatectomy | 31% (70/225) of group initially contacted randomized #m | 79% (55/70) follow-up |
| Wooten (2015) [ | 3-arm RCT | Australia (15–18% inner regional) | Interventions MRA only: | Localized PC | 86% radical prostatectomy | 95% (142/150) of recruitment target met ^nm | 87% midweek follow-up |
| Yanez (2015) [ | 2-arm RCT | USA | Intervention | 49% advanced | 100% on ADT | 13% (74/240) of recruitment rate target met^nm | 86% intervention vs. 86% control follow-up |
ADT androgen deprivation therapy, PC prostate cancer, RCT randomized controlled trial, FF face-to-face, PIES prostate interactive education system, T-PIES tailored PIES, NT-PIES non-tailored-PIES, UC usual care, V-CIS virtual cancer information service, WL wait-list, FF face-to-face, OV office visits, VV video visits, EBRT external beam radiation therapy
*npRecruitment target not provided
^nmRecruitment target not met
#mRecruitment target met
Intervention overview and engagement and acceptability outcomes
| Source (author and year) | Objectives and description of intervention | Engagement (usage) | Acceptability (satisfaction) | Conclusions |
|---|---|---|---|---|
| Cathala (2003) [ | Objective: test and evaluate online medical file in lieu of face-to-face visit | First 6 months tracked by the “connection report system” | 98% satisfied with various site sections | The online medical program approach was determined to be useful and acceptable for those patients requiring regular follow up. |
| Davison (2014) [ | Objective: to prepare and identify treatment preferences and reduce decisional conflict during selection of PC treatment. | 61% shared summary sheet with a health care worker involved in care: 35% with urologist | Patients satisfied with amount of information (96%), type of information (93%), way delivered (89%), involvement in decision (91%), and treatment choice (96%) | The use of this support aid was found to be acceptable to patients, for use at home or in clinic. |
| Johnson (2016) [ | Objective: to support patients with shared decision-making and reduce decisional conflict for men with newly diagnosed LPC prior to treatment decision. | 76% of men invited voluntarily completed the decision support module | 82% mostly satisfied or delighted with quality of care | 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. |
| Kazer (2011) [ | Objective: to support patients to improve knowledge and self-efficacy, and reduce uncertainty during AS for PC. | 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) [ | Objective: to support mental health (e.g. reduce distress and improve QoL) in PC survivors. | 100% of intervention group completed the evaluation session | Overall positive evaluation of program (1 = strongly agree; 5 = strongly disagree) | 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. |
| Song (2015) [ | Objective: to support patients’ knowledge of symptom management, communication skills, and improve QoL in LPC post-treatment patients. | No report of participant engagement in mandatory modules. | Overall positive evaluation of program (1 = strongly disagree; 5 = strongly agree) | The study found the intervention (PERC) was a feasible and acceptable method of reducing side effects of PC treatment-related symptoms and improving QoL. |
| Berry (2013) [ | Objective: reduce uncertainty and decisional conflict during selection of PC treatment. | Time to complete average 46 min (range 16 to 69 min) [ | (Higher score = more positive) [ | P3P is a useable and acceptable decision support system that can be deployed in a clinical setting [ |
| Berry (2017) [ | Objective: reduce uncertainty and decisional conflict during selection of PC treatment. | Pilot study [ | (Higher score = more positive) [ | This aid to shared decision-making may be helpful to support men recently diagnosed with LPC. |
| Diefenbach (2012) [ | Objective: to support patients to improve knowledge of treatments, side effects, self-efficacy, and QoL, and reduce uncertainty during AS for PC. | 79% (72/91) completed post measures | Total sample (higher score = more positive) | The implementation of PIES within a clinical practice was found to be feasible and acceptable to patients recently diagnosed with prostate cancer. |
| Fleisher (2015) [ | Objective: to support patients to improve knowledge of treatments, side effects, and promote informed decision-making for newly-diagnosed PC patients. | 96% in intervention group read the print materials | Overall satisfaction | 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. |
| Osei (2013) [ | Objective: to support and improve patients’ knowledge (of treatments and side effects) and QoL in patients diagnosed with PC. | Study did not report actual usage. | Overall program satisfaction | 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) [ | Objective: to support and improve patients’ knowledge and QoL, and lower symptom distress in patients diagnosed with PC. | Activity log tracked server details by ID for participants. 2 reports were generated; usage and user report. | 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. [ | The study found WebChoice to be a promising tool to help cancer patients better manage their illness and reduce symptom distress. |
| Schover (2012) [ | Objective: to support and improve patients’ knowledge of and manage symptoms of erectile dysfunction, and improve sexual satisfaction in PC survivors. | 52% of men and 44% of partners completed > 75% of the web site | 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. |
| Viers (2015) [ | Objective: to replace traditional patient visits and improve cost, efficiency and patient satisfaction in PC patients post-prostatectomy. | 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. | The majority (96%) of patients undergoing VV would participate in this type of encounter again. |
| Wooten (2015) [ | Objective: to support patients to improve their knowledge and reduce psychological distress in LPC patients undergoing treatment. | 59% (mean) content completed | Overall satisfaction | The intervention was received positively by participants in the pilot study. |
| Yanez (2015) [ | Objective: to support patients to ease their symptom burden and improve QoL in advanced PC patients. | CBSM-intervention group attended 6.59/10 sessions (SD = 3.35) | No between group difference in exit survey scores (4-items). 4-point scale (higher numbers = more positive) | Findings generally support the feasibility, acceptability and preliminary efficacy of this CBSM psychosocial intervention for men with advanced prostate cancer. |
EHR electronic health record, PSA prostate specific antigen, PC prostate cancer, HCP health care provider, LPC localized prostate cancer, AS active surveillance, PERC Prostate Cancer Education and Resources for Couples; P3P: Personal Patient Profile – Prostate, DC decisional conflict, YTL years to live, PIES prostate interactive education system, T-PIES tailored PIES, NT-PIES non-tailored-PIES, UC usual care, V-CIS virtual cancer information service, WL wait-list, FF face-to-face, OV office visits, VV video visits, CBT cognitive behavioral therapy, MRA My Road Ahead, CBSM Cognitive Behavioral Stress Management, HP health promotion, QoL Quality of Life
Summary of RCT results reporting study efficacy outcomes
| Source | Design | Outcomes measured | Efficacy results | Conclusions |
|---|---|---|---|---|
| Berry (2013) [ | 2-arm RCT ( | Primary: decisional conflict subscales including: uncertainty, informed, values clarity, and support. | Primary | Findings support efficacy of the P3P intervention for addressing uncertainty and facilitating selection of a treatment. |
| Berry (2017) [ | 2-arm RCT ( | Primary: total score on modified low literacy decisional conflict scale (reported at baseline and 1 month) | Multivariate model: (LS mean (95%CI); | 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. |
| Diefenbach (2012) [ | 3-arm RCT ( | Primary: treatment decisional measures | No difference between T-PIES vs. NT-PIES therefore PIES groups were combined for these comparisons vs control. | 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. |
| Osei (2013) [ | 2-arm RCT ( | Primary: QoL (general and cancer specific, life satisfaction, relationship satisfaction) | MANOVAs mean differences across time | The results suggest that online support groups can have a positive effect on perceived QoL of men. |
| Ruland (2013) [ | 2-arm RCT ( | Primary: symptom distress | Note: efficacy outcomes were not reported separately for breast vs. PC survivors. | That WebChoice is a promising tool to help cancer patients better manage their illness and reduce symptom distress, is partially supported by the data. |
| Schover (2012) [ | 3-arm RCT ( | Primary: erectile function for PC; female sexual function for partners. | No significant changes in outcome measures during WL period | 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) [ | 2-arm RCT ( | Primary: visit efficiency (measured by time) | No difference between groups in (VV mean vs. OV mean; (95% CI); | VVs had equivalent timing efficiency, similar patient satisfaction, and significantly reduced costs when compared to OVs. |
| Wooten (2015) [ | 3-arm RCT ( | Primary: psychological distress (DASS-21) | Pairwise comparisons | 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) [ | 2-arm RCT ( | Acceptability (main outcome detailed in Table | CBSM mean vs. HP mean; | Participants in HP condition were more likely to attend study sessions than participants in the CBSM condition. |
PSA prostate specific antigen, PC prostate cancer, HCP health care provider, LPC localized prostate cancer, AS active surveillance, PERC Prostate Cancer Education and Resources for Couples, P3P Personal Patient Profile – Prostate, DC decisional conflict, EUH Emory University Hospital, YTL years to live, PIES prostate interactive education system, T-PIES tailored PIES, NT-PIES non-tailored-PIES, QoL Quality of Life, NCI National Cancer Institute, MSAS-SF Memorial Symptom Assessment Scale-Short Form, GDI global distress index, UC usual care, V-CIS virtual cancer information service, WL wait-list, FF face-to-face, IIEF International Index of Erectile Function, FSFI Female sexual function index, OV office visits, VV video visits, CBT cognitive behavioral therapy, MRA My Road Ahead, CBSM Cognitive Behavioral Stress Management, HP health promotion, IES-R Impact of Event Scale–Revised, ANOVA analysis of variance, ANCOVA analysis of covariance, MANOVA multiple ANOVA