Table 2.

Interventions Evaluated using Randomized Controlled Trial/Quasi-Experimental Methods Included in Review.

Author	Cancer type	Domain	Sample size	Brief Description	Primary Outcomes	Significance
Quasi-Experimental Design
Kushalnagar, 2018[12]	Breast cancer	Prevention	74	Computer-assisted text simplification for breast cancer information compared to original (unsimplified) text	Knowledge	(ns) Simplified messages μ=91.4 [SE=1.4] vs. original text condition μ=88.6 [SE=1.8], adjusting for HL
Davis, 2014[13]	Breast cancer	Screening	1,181	3 study conditions: (1) Enhanced mammography care; (2) Enhanced care plus health-literacy informed education; (3) Enhanced care plus health-literacy informed education plus nurse support	Completion of Mammography (6 months; nurse-documented)	(ns) Education and enhanced care arm screening ratio=0.87, 95 % CI= 0.62,1.22, p = 0.42; (ns) Nurse and enhanced care screening ratio=1.19; 95 % CI=0.85, 1.65, p=0.31
Love, 2012[14]	Cervical cancer	Screening	498	Entertainment-education video compared to print handouts among Southeast Asian women	Stage of Readiness to complete Pap Testing	(ns) Change in Stage of Readiness
Arnold, 2016[15]; Arnold, 2016[52]; Davis, 2014[51 ]; Davis, 2013[50]	Colorectal Cancer	Screening	961	3 study conditions: (1) Enhanced care (screening recommendation and fecal occult blood testing kit mailed annually); (2) Enhanced care + education (health literacy-appropriate pamphlet and simplified testing instructions); (3) Enhanced care + education + nurse support	Completion of three FOBTs or positive FOBT with Colonoscopy	(ns) For all three nurse arm screening ratio=1.11; 95 % CI 0.76-1.62; p=0.59
Randomized Between Subject Design
Meppelink, 2015[16]	Colorectal Cancer	Screening	559	Computer based evaluation of a two (illustrated vs. text-only) by two (non-difficult vs. difficult text) design	Recall (NPIQR), attitudes, intention to screen	(+) Recall for non-difficult text in low HL group vs. the difficult-high HL group; Illustrations added to difficult text for LHL group improved recall (8.49 to 10.88 for LHL vs. 13.25 to 14.77 for HHL illustration addition); (+) Effect of adding illustrations for attitude toward screening; (ns) Impact on intentions
Meppelink, 2015[17]	Colorectal Cancer	Screening	231	Computer based evaluation to assess spoken vs. written and animated vs. illustrated in a two by two design	Recall	(+) Spoken better recall: μ=13.6, but driven by LHL group (EM) vs. 11.97; (+) Animation has better recall only among LHL group compared with illustrations; (ns) Interaction between text and visual format modalities on recall
Cluster-Randomized Controlled Trial Design
Smith, 2017[18]	Colorectal Cancer	Screening	163,525	Evaluated a standard information booklet compared to a booklet and gist information leaflet	Completed FOBT screen (18-weeks)	(ns) Overall screening uptake OR=1.02, 95% CI: 0.92, 1.13, p=0.77)
Han, 2017[19]	Breast and Cervical Cancer	Screening	560	Individually tailored cancerscreening brochure, community health worker health literacy training, and counseling among Korean American women versus usual care	Adherence to cancer screening guidelines (Mammography & Pap; self-report, 6-months)	(+) Mammography OR: 18.5, 95% CI=9.2, 37.4; (+) Pap OR: 13.3, 95% CI= 7.9, 22.3; (+) Both tests OR: 17.4, 95% CI= 7.5, 40.3
Tong, 2017[20]	Colorectal Cancer	Screening	329	Evaluated colorectal cancer education over 3 months delivered by a lay health educator compared to education about nutrition and physical activity delivered by a health educator	CRC screening (ever and up to date at 6 months, self-report)	(+) Ever screen OR: 1.95, 95% CI: 1.4, 2.72; (+) Up to date OR: 1.73, 95% CI: 1.34, 2.21
Epstein, 2017[53]; Duberstein, 2019[41]	All Cancer Types, Caregivers and Providers	Treatment	303 [103]	Evaluated a communication training to improve communication among oncologists, patients, and caregivers at the end-of-life compared to control patients who received no training	Composite communication score	(+) Composite communication score (estimated adjusted intervention effect, 0.34; 95% CI: 0.06,0.62; p=0.02)
Price-Haywood, 2014[21]; Price-Haywood, 2010[22]	Colorectal, Breast, Cervical Cancer Screening and Providers	Screening	168 [18]	Assessed communication training and web-based standardized patient audit and feedback compared to audit and feedback only	Standardized patients’ ratings of provider communication, patient knowledge, patient screening	(+) Standardized patient ratings of physician communication (6-month ratings 4.1 [1.1] vs. 3.1 [1.3]; p<0.05; 12-month ratings 4.1 [1.1] vs. 2.3 [0.8], p<0.05); (+ and ns) Mammography only (other cancer types); (ns) Patient knowledge of cancer screening guidelines
Randomized Controlled Trial Design
Ferreira, 2005[23]; Dolan, 2015[24]	Colorectal Cancer and Providers	Screening	1,978 [503; 270]	Investigated a clinician communication training workshop intervention to improve colorectal cancer screening when compared to usual care	Rates of colorectal cancer screening recommendation by providers; rates of completion of colorectal cancer screening by patients	(+) Provider recommendation 76.0% vs. 69.4%; (+) Patients with limited health literacy completion intervention 55.7% vs. control 30.0%
Bodurtha, 2014[25]	Breast and Colorectal Cancer	Prevention	490	An interactive intervention to communicate cancer risk with family members compared to an informational handout	Family Communication (self-report)	(+) Gather information OR: 2.73, 95% CI: 2.01, 3.71; Communicate with family odds ratio: 1.85; 95% CI: 1.37, 2.48
Kripalani, 2012[27]	Prostate cancer	Screening	250	Employed communication cueing to increase patient-provider prostate cancer screening discussions. This investigation compared: (1) a patient education handout, (2) cueing handout, (3) food pyramid (control)	Discussion of Prostate Cancer Within Visit	(+) Cue vs. Control OR: 2.39, 95% CI:1.26, 4.52; (+) Education vs. Control OR: 1.92, 95% CI: 1.01, 3.65
Reuland, 2017[26]	Colorectal Cancer	Screening	265	A patient decision aid plus navigation with a trained health worker used to improve colorectal cancer screening compared to usual care	Completion of CRC Screening (6 months; HER review)	(+) 40% difference, 95% CI: 29%, 51%)
Gummersbach, 2015[29]	Breast cancer	Screening	353	Comparing a lower information leaflet to a greater information leaflet to assess willingness to complete mammography screening	Intention to screen	(ns) 7.1% difference (−0.9% −14.3%); (new leaflet [greater information] 81.5%, 95% CI: 75.8%, 87.2% vs. old leaflet [less information] 88.6%, 95% CI: 83.9%, 91.3%, p=0.060).
Horne, 2016[28]	Colorectal Cancer	Screening	1220	Comparing patient education to a patient education plus patient navigation intervention to improve up-to-date colorectal cancer screening	Completion of CRC Screening (self-report)	(+) OR 1.56, 95% CI: 1.08, 2.25
Baker, 2014[31 ]	Colorectal Cancer	Screening	450	Usual care included computerized reminders, standing FIT orders, and clinician feedback. The intervention group also received a mailed reminder, a free FIT with low-literacy instructions, and a postage-paid return envelope; an automated telephone and text message reminding them that they were due for screening and that a FIT was being mailed to them; an automated telephone and text reminder 2 weeks later for those who did not return the FIT; and personal telephone outreach by a CRC screening navigator after 3 months.	Completion of FOBT (HER review; 6 months)	(+) 44.9% difference between groups; Intervention 82.2% vs. control 37.3%; p<0 .001
Landrey, 2013[30]	Prostate Cancer	Screening	303	Assessed the impact of a mailed low-literacy informational flyer about the prostate cancer screening compared to usual care	Documented PSA Discussion, patient preference, and PSA testing (chart review)	(ns) For all chart review outcomes (flyer 62.5% vs. usual care 58.5%; p=0.48), shared decision making (documented patient-provider discussion, flyer 17.7% vs. usual care 13.6%; p=0.28), or knowledge (flyer 3.5/5 vs. usual care 3.3/5, p=0.60) over 12-months
Freed, 2013[33]	Colorectal Cancer	Screening	60	Evaluated the use of two texts: one with a low Flesh-Kincaid reading level and a control text	Recognition memory	(+) β=0.42 [0.17, 0.68]
Katz, 2012[32]	Colorectal Cancer	Screening	270	Assessed whether screening information, activating patients to ask for a screening test, and telephone barriers counseling improved colorectal cancer screening when compared to screening information	Completion of CRC screening (2 months; medical record review)	(+) OR: 2.35, 95% CI: 1.14, 5.56; p=0.020
Fiscella, 2011[47]; Hendren, 2014[54]	Breast Cancer and Colorectal Cancer	Screening	469 [366]	A multimodal intervention (e.g., tailored letters, personal phone calls, prompts) to improve cancer screening rates vs. standard of care	Completion of screening (mammography or CRC; 12 months, chart review)	(+) For both Mammography OR: 3.44 (95% CI: 1.91, 6.19) & CRC screening OR: 3.69 (95% CI: 1.93, 7.08)
Valdez, 2018[35]	Cervical Cancer	Screening	943	Assessed an interactive, one-time low-literacy cervical cancer education program through a multimedia kiosk in English or Spanish compared to usual care	Completion or Scheduling of Cervical Cancer Screening (defined as having had a Pap test or made an appointment in the interval between pre- and posttest; screening behavior)	(ns) Screening behavior OR: 1.14, 95% CI: 0.84, 1.55
Miller, 2011[34]	Colorectal Cancer	Screening	264	Evaluated a web-based colorectal cancer screening decision aid compared to a control about prescription drug refills and safety	State a screening test preference; readiness to receive screening	(+) Test preference aOR: 5.3, 95% CI: 2.8, 10.1; Readiness aOR 4.7, 95% CI: 1.9, 11.9
Volk, 2008[36]	Prostate Cancer	Screening	450	Investigated a prostate cancer entertainment education video designed for individuals with limited health literacy compared to an audiobooklet control	Knowledge	(+) Knowledge (magnitude unreported)
Smith, 2010[37]; Smith, 2014[55]	Colorectal Cancer	Screening	572 [21]	Evaluated a colorectal cancer screening patient decision aid and video compared to standard information	Informed choice and preferences for involvement in the screening decision	(+) Knowledge decision aid arm=6.50, 95% CI: 6.15, 6.84; control group arm mean=4.10, 95% CI: 3.85, 4.36; p<0.001; (+) Informed choice 22% difference, 95% CI: 15%, 29%; p<0.001; (+) Preference for involvement in screening decision OR 2.47, 95% CI: 1.07, 5.69
Davis, 2017[49]	Colorectal Cancer	Screening	416	Evaluated a multicomponent intervention incorporating a targeted health literacy enhanced photonovella compared to standard, non-targeted information	Screening with FIT within 180 days of delivery of the intervention	(ns) Screening uptake was 78.1% in the CARES condition and 83.5% in the comparison condition (p=0.17); FIT kit uptake, no difference was observed between the conditions (p=0.32).
Meade, 1994[48]	Colorectal Cancer	Screening	1,100	Assessed a video intervention compared to a booklet to improve knowledge of colorectal cancer screening	Knowledge, recall	(+) Booklet mean score difference 1.7; video mean score difference 1.9; control mean score difference 0.2; p<0.05. No statistically significant difference was noted between the booklet and videotape groups.
Visser, 2019[39]	All Cancer Types	Treatment	217	Investigated the effects of oncologists’ training and utilization of: (1) emotion-oriented speech, (2) emotion-oriented silence, and (3) standard communication	Investigate and compare the effects of oncologists’ emotion-oriented speech and emotion-oriented silence on information recall (free recall and recognition)	(ns) Free recall (F(2, 201)=0.64, p=0.529, effect size partial η2=.01); (+) Recognition (F(2, 201)=0.64, p=0.529, effect size partial η2=.05); (+) Emotion oriented recognition; (ns) Emotional stress mediator; (ns) Health literacy moderator (p=0.136, R2= .041);
Jibaja-Weiss, 2011[40]	Breast Cancer	Treatment	76	Evaluated an entertainment education intervention designed to improve clarity and knowledge of breast cancer treatment surgical options when compared to usual care	Treatment preference, knowledge, satisfaction with decision, satisfaction with decision-making process, decisional conflict	(−) Breast conserving surgery (40.5% vs. 50.0%); (+) radical mastectomy (59.5% vs. 39.5%,p=0.018); (+) Knowledge; (ns) Satisfaction; (mixed) decisional conflict [(+) surgical options and personal values; (ns) uncertainty; (ns) social support]
Dyer, 2019[42]	Breast Cancer	Treatment	64	Investigated a physician-communicated detailed radiation therapy plan, including a visualization, of the patient radiation therapy plan compared to a nondetailed review	Patient Reported Outcomes; Quality of Life (FACIT-TS-PS)	(ns) Patient Reported Outcomes; Quality of Life (p=0.63, .53, 0.52, and 0.71)
Heckel, 2018[43]	All Cancer Types, Caregivers and Providers	Treatment	216	Evaluated a cancer patient and caregivers telephone outcall program compared to an attention control group to address caregiver burden	Self-reported caregiver burden	(ns) Caregiver burden (p=0.921)
Keohane, 2017[44]	Breast cancer	Prevention	84	Evaluated an application to improve risk perception when compared to standard risk counseling among patients attending a high risk breast clinic	Risk perception	(+) Increased risk accuracy (Control group increase from 21% to 48% vs Treatment group increase from 33% to 71%; p=0.003); (ns) Risk perception (<30% difference between groups)
Kusnoor, 2016[45]; Giuse, 2016[56]	Melanoma , lung, and Renal Cancer and Caregivers	Treatment	107 [90]	Assessed an intervention to improve knowledge by translating web-based cancer genomic information into videos compared to professional-level content	Knowledge; knowledge retention	(+) Knowledge [easy to understand (p=0.01), was confusing (p=0.014), and if they were satisfied with the information (p=0.03)]
Chambers, 2014[46]	All Cancer Types and Caregivers	Treatment	690	Assessed a single session of a nurse-led self-management intervention compared to a five-session psychologist cognitive behavioral intervention delivered by telephone	Psychological and cancer-specific distress and post-traumatic growth	(ns) Distress and post-traumatic growth [distress decreased over time in both arms with small to large effect sizes (Cohen’s ds = 0.05-0.82). Post-traumatic growth increased overtime for all participants (Cohen’s ds = 0.6-0.64)]
Hoffman, 2016[57]	Colorectal Cancer	Prevention	89	Assessed a patient decision aid video containing culturally tailored information about colorectal cancer screening options in an entertainment education format compared to an attention control video about hypertension	Decision making, knowledge, colorectal cancer screening behavior	(+) Knowledge (intervention mean increase 2.7 vs. control mean increase 0.4, p< .01); lower (improved) decisional conflict (intervention mean 11.0 vs. control mean 39.6; p< .01); (ns) Screening completion (1-3 weeks; 3 months)