Brief report of a tablet-delivered psychosocial intervention for men with advanced prostate cancer: Acceptability and efficacy by race

Probably not a substantial claim: may not pass S3 (load-bearing).

Across time, men in both conditions reported MAX-PC scores that remained within 1 SD of scores reported in other samples of APC.

“Across time, men in both conditions reported MAX-PC scores that remained within 1 SD of scores reported in other samples of APC [20].”

• cites [20] Johanes, 2013, Anxiety level of early- and late-stage prostate cancer patients, Prostate Int sourcePartly supported

  The Results report mean MAX-PC scores of 8.32 and 12.61 for early- and advanced-stage patients. The Discussion compares this study’s overall mean with another sample’s mean of 9.3 ± 6.8; both group means fall within one standard deviation of that figure. But this was a cross-sectional comparison of disease stages, not a study of two conditions followed across time, so the longitudinal claim is unsupported. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Elevated distress is reported in 16-31% of PC patients.

“Elevated distress is reported in 16-31% of PC patients, and approximately 6% of patients meet criteria for a psychiatric disorder (e.g., mood disorders) [2,3].”

• cites [2] Roth, 1998, Rapid screening for psychologic distress in men with prostate carcinoma: a pilot study, Cancer sourceNot checked — no full text of the source
• cites [3] Mehnert, 2010, Depression, anxiety, post-traumatic stress disorder and health-related quality of life and its association with social support in ambulatory prostate cancer patients, Eur J Cancer Care (Engl) sourcePartly supported

  The Psychological co-morbidity and HRQOL section reports increased psychological distress or a probable psychiatric disorder in 16.2% of the study's ambulatory prostate cancer patients. The Introduction reports a wider 13–53% range across studies, but the paper does not report the claimed 16–31% range; only its lower end is supported. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Black men are more likely to be diagnosed with metastatic disease (stage IV).

“Black men are also more likely to be diagnosed with metastatic disease (stage IV) [5] for which the 5-year survival rate drops to 30% [1], and black men are 2.4 times more likely to die from PC compared with NHW men [3].”

• cites [5] Anai, 2006, Prostate cancer screening and detection in inner-city and underserved men, J Natl Med Assoc sourcePartly supported

  The Results (abstract; page unavailable) report that African American men in this inner-city cohort more often had advanced disease or distant metastasis than the comparison groups (16.1% versus 3.8% and 0%). The paper combines T3/T4, N1, and M1 cases, so it does not establish a higher rate specifically of metastatic (stage IV) diagnoses. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Another study found evidence of protective resiliency among black PC patients.

“Two studies found lower health-related quality of life (HRQoL) in black PC patients relative to NHW patients [6,7], whereas another study found evidence of protective resiliency among black PC patients [8].”

• cites [8] Nelson, 2010, Distress, anxiety, depression, and emotional well-being in African-American men with prostate cancer, Psychooncology sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Black men are 2.4 times more likely to die from PC compared with NHW men.

“Black men are also more likely to be diagnosed with metastatic disease (stage IV) [5] for which the 5-year survival rate drops to 30% [1], and black men are 2.4 times more likely to die from PC compared with NHW men [3].”

• cites [3] Mehnert, 2010, Depression, anxiety, post-traumatic stress disorder and health-related quality of life and its association with social support in ambulatory prostate cancer patients, Eur J Cancer Care (Engl) sourceCould not verify

  The Introduction discusses prostate cancer incidence and psychosocial distress, while the results address psychological outcomes in ambulatory patients; neither reports mortality by race. Searches for the 2.4-fold mortality figure and Black-versus-non-Hispanic-White comparisons found no supporting passage in our copy. (LLM, conf=0.78)

  Experimental — accuracy not yet measured

May combine two claims.

We used a measure validated specifically with black and APC patients to assess preliminary efficacy, increasing the validity of our findings.

“We also used a measure validated specifically with black and APC patients to assess preliminary efficacy, increasing the validity of our findings.”

• cites [19] Nelson, 2016, Assessing anxiety in Black men with prostate cancer: further data on the reliability and validity of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), Support Care Cancer sourcePartly supported

  The Discussion reports that the MAX-PC was reliable and valid in a sample of Black men with prostate cancer. The Methods (Participants) say the sample included both early- and late-stage disease, but the paper does not establish validation specifically for advanced prostate cancer patients as a separate group. The statement that using the measure increased the citing study’s validity is the citing authors’ own conclusion. (LLM, conf=0.82)

  Experimental — accuracy not yet measured
• cites [20] Johanes, 2013, Anxiety level of early- and late-stage prostate cancer patients, Prostate Int sourcePartly supported

  The Data collection section (page unavailable) says the study used the MAX-PC anxiety questionnaire and reports that it had been validated in studies in New York and Rotterdam. It does not say the measure was validated specifically with Black and APC patients or used to assess preliminary efficacy; this study assessed anxiety in early- and advanced-stage prostate cancer patients. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

May combine two claims.

Our team has adapted CBSM for older men with APC, and we have shown preliminary feasibility and acceptability in a small sample.

“Our team has adapted a psychosocial intervention (Cognitive Behavioral Stress Management [CBSM]) [11] for older men with advanced PC (APC; stages III-IV), and we have shown preliminary feasibility and acceptability in a small sample [12].”

• cites [11] Penedo, 2008 sourceNot checked — no full text of the source
• cites [12] Yanez, 2015, Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer, Cancer sourceSupported

May combine two claims.

The following rates were deemed acceptable based on prior studies of advanced or metastatic cancer patients: 70% retention and 70% average session attendance.

“We tracked study retention and attendance, and the following rates were deemed acceptable based on prior studies of advanced or metastatic cancer patients: 70% retention and 70% average session attendance [16,17].”

• cites [16] Campbell, 2007, Facilitating research participation and improving quality of life for African American prostate cancer survivors and their intimate partners. A pilot study of telephone-based coping skills training, Cancer sourceCould not verify

  The Recruitment and retention section (page not available) reports that 15 of 20 treatment couples completed treatment and describes session adherence, but gives no 70% acceptability threshold. Searches for 70% retention, 70% average session attendance, and prior studies of advanced or metastatic cancer patients found no passage establishing those criteria. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites [17] Kissane, 2007, Supportive-expressive group therapy for women with metastatic breast cancer: survival and psychosocial outcome from a randomized controlled trial, Psychooncology sourceNot checked — no full text of the source

May combine two claims.

Men in CBSM versus HP reported greater reductions in PC-anxiety at 6 months, but this benefit was not sustained at 12 months.

“Men in CBSM (vs.HP) reported greater reductions in PC-anxiety at 6 months (not sustained at 12 months).”

• Also stated in: § Efficacy: PC-anxiety · plain

  “From T1 to T2, there was a more negative slope in CBSM vs. HP (b = -2.69,SE = 1.05, p = .011),but this was not sustained at T3 (p > .05).”

• Also stated in: § DISCUSSION · plain

  “Exploratory analyses of efficacy for reducing disease-specific distress in the total sample revealed an overall intervention effect on decreased PC-anxiety at 6 months, but this benefit was not sustained at 12 months.”

May combine two claims.

Men in CBSM versus HP had lower MAX-PC scores at T2, but not at T3.

“Men in CBSM versus HP had lower MAX-PC scores at T2 (p = .025),but not T3 (p > .05).”

May combine two claims.

All other groups (black men in HP, NHW men in CBSM, NHW men in HP) did not report significant changes in MAX-PC scores over time.

“By comparison, all other groups did not report significant changes in MAX-PC scores over time (i.e., black men in HP, NHW men in CBSM, NHW men in HP).”

• Also stated in: § Efficacy: PC-anxiety · plain

  “For black participants in the HP condition, MAX-PC scores did not change from T1 to T2 or T1 to T3 (ps > .05).”

May combine two claims.

Average exit survey responses were favorable and similar for CBSM and HP.

“Average exit survey responses were favorable and similar for CBSM (M = 3.53, SD = 0.55) and HP (M = 3.65, SD = 0.41; p > .05).”

May combine two claims.

Within CBSM, MAX-PC scores were significantly lower at T2 versus T1, and this was maintained at T3.

“Pairwise comparisons showed that, within CBSM, MAX-PC scores were significantly lower at T2 versus T1 (p < .001),and this was maintained at T3 (p = .011).”

May combine two claims.

CBSM and HP were both acceptable among older APC patients.

“CBSM and HP were both acceptable among older APC patients.”

• Also stated in: § DISCUSSION · plain

  “Tablet-delivered CBSM and attention-matched HP were both acceptable to this sample, and participants were engaged with both conditions.”

May combine two claims.

Black men in CBSM reported a significant reduction in PC-anxiety at 6 months, which was maintained at 12 months.

“Black men in CBSM reported a significant reduction in PC-anxiety at 6 months, which was maintained at 12 months.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Black men reported lower SES (e.g., lower education and income) compared to NHW men in this sample.

“There were demographic differences between NHW and black men across study conditions; black men reported lower SES (e.g., lower education and income) compared to NHW men in this sample.”

May combine two claims.

Within HP, MAX-PC scores did not change from T1 to T2 or T1 to T3.

“Within HP, MAX-PC scores did not change from T1 to T2 or T1 to T3 (ps > .05).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Black men were more likely to be recruited from the VA medical center than NHW men.

“Black men were also more likely to be recruited from the VA medical center than NHW men.”

May combine two claims.

There were 24 adverse events during the study (6 hospitalizations, 17 deaths, and 1 new cancer diagnosis).

“There were 24 adverse events during the study (6 hospitalizations, 17 deaths including men lost to follow up and after the T3 assessment, and 1 new cancer diagnosis).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Baseline MAX-PC scores were higher in CBSM than in HP.

“There were no differences between men randomized to CBSM and HP on demographic or medical variables, but baseline MAX-PC scores were higher in CBSM.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All adverse events were unrelated to the present study's treatment.

“All adverse events were unrelated to the present study's treatment.”

May combine two claims.

Older age and lower socioeconomic status are barriers to recruitment and retention in psychosocial cancer research.

“Older age and lower socioeconomic status (SES) are barriers as well, as they frequently relate to study design barriers (e.g., age restrictions, functional status) [9].”

• cites [9] Ford, 2008, Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review, Cancer sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

All participants gave informed consent, approved by the IRB at each institution.

“All participants gave informed consent (approved by the IRB at each institution).”

Classified as probably not a substantial claim.

We used linear mixed effects modeling to assess three models of change in MAX-PC scores over time controlling for age, comorbidities, and baseline MAX-PC scores.

“We used linear mixed effects modeling to assess three models of change in MAX-PC scores over time controlling for age, comorbidities [22], and baseline MAX-PC scores.”

• cites [22] Chipperfield, 2013, Predictors of depression, anxiety and quality of life in patients with prostate cancer receiving androgen deprivation therapy, Psychooncology sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

We analyzed MAX-PC for normality and Winsorized outliers of >3 SD from the mean.

“We analyzed MAX-PC for normality and Winsorized outliers of >3 SD from the mean [21].”

• cites [21] Wilcox, 1993, Some results on a Winsorized correlation coefficient, Br J Math Stat Psychol sourceNot checked — no full text of the source

May combine two claims.

All participants were provided tablets, which limits generalization to individuals without access to mobile technology.

“All participants were provided tablets, which limits generalization to individuals without access to mobile technology.”

Classified as probably not a substantial claim.

All data available were used to estimate models, so that participants were included at each time point for which they provided data (as opposed to listwise deletion).

“All data available were used to estimate models, so that participants were included at each time point for which they provided data (as opposed to listwise deletion).”

Classified as probably not a substantial claim. May combine two claims.

CBSM integrates cognitive-behavioral stress and self-management skills with relaxation skills training to improve HRQoL and reduce symptoms.

“CBSM integrates cognitive-behavioral stress and self-management skills (e.g., cognitive restructuring) with relaxation skills training (e.g., deep breathing) to improve HRQoL and reduce symptoms [11].”

• cites [11] Penedo, 2008 sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

Participants were randomized (1:1) to CBSM or HP, and groups were stratified by disease status (advanced vs. metastatic disease).

“Participants were randomized (1:1) to CBSM or HP (four to six men per condition), and groups were stratified by disease status (advanced vs. metastatic disease).”

Probably not a substantial claim: may not pass S3 (load-bearing).

We adjusted pairwise comparisons with Sidak correction for multiple comparisons.

“We adjusted pairwise comparisons with Sidak correction for multiple comparisons [23].”

• cites [23] Sidak, 1967, Rectangular confidence regions for the means of multivariate normal distributions, J Am Stat AssocNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Black men face unique barriers limiting their involvement in clinical trials, such as limited awareness of trials and lower acceptance into trials.

“Black men face unique barriers limiting their involvement in clinical trials such as limited awareness of trials and lower acceptance into trials [9,10].”

• cites [9] Ford, 2008, Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review, Cancer sourceNot checked — no full text of the source
• cites [10] Rivers, 2013, A systematic review of the factors influencing African Americans’ participation in cancer clinical trials, Contemp Clin Trials sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

PC disproportionately affects black men, with 70% higher incidence than NHW men.

“PC disproportionately affects black men, with 70% higher incidence than non-Hispanic white (NHW) men [4].”

• cites [4] American Cancer SocietyNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

Sessions were recorded and reviewed in weekly supervision with licensed clinical psychologists trained in both protocols to ensure intervention fidelity.

“Sessions were recorded and reviewed in weekly supervision with licensed clinical psychologists trained in both protocols to ensure intervention fidelity.”

Probably not a substantial claim: may not pass S3 (load-bearing).

We projected that with 150 participants retained at T3 and a .05 alpha level, we would have a power of 0.86 for detecting intervention effects on HRQoL.

“We projected that with 150 participants retained at T3 and a .05alpha level, we would have a power of 0.86 for detecting intervention effects on HRQoL.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

We did not collect information about race prior to study enrollment because race was not part of our eligibility criteria; consequently, differences in recruitment by race could not be assessed.

“We did not collect information about race prior to study enrollment because race was not part of our eligibility criteria; consequently, differences in recruitment by race could not be assessed.”