Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

Abstract Background The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. Methods The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. Results After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. Conclusions Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

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Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

10.21203/rs.3.rs-19034/v1 ◽

2020 ◽

Author(s):

Yukari Isaka ◽

Ai Hori ◽

Rie Tanaka ◽

Masao Ichikawa

Keyword(s):

Cervical Cancer ◽

Psychological Distress ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

And Control ◽

Screening Result

Abstract Background: The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress.Methods: This study design was a simple randomized controlled trial that randomly assigned individual participants to the intervention and control groups and measured outcomes before and after the intervention. The analysis included 972 women. Women received hypothetical cervical cancer screening results, with a leaflet (intervention group) or without it (control group), randomly. Outcomes were psychological distress and intention to undergo further examination.Results: After the intervention, psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.Conclusions: Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer.Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

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Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

10.21203/rs.3.rs-19034/v2 ◽

2020 ◽

Author(s):

Yukari Isaka ◽

Ai Hori ◽

Rie Tanaka ◽

Masao Ichikawa

Keyword(s):

Cervical Cancer ◽

Psychological Distress ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Control Groups ◽

And Control ◽

Screening Result

Abstract Background: The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial.Methods: The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups.Results: After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.Conclusions: Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer.Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

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Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus–Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial (Preprint)

10.2196/preprints.15863 ◽

2019 ◽

Author(s):

Ditte S Linde ◽

Marianne S Andersen ◽

Julius Mwaiselage ◽

Rachel Manongi ◽

Susanne K Kjaer ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Intervention Group ◽

Text Messages ◽

Control Group ◽

Randomized Controlled ◽

Parallel Group

BACKGROUND Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive. OBJECTIVE This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. METHODS This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. RESULTS Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial—358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). CONCLUSIONS Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. CLINICALTRIAL ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10.2196/15863

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SMS behaviour change communication and eVoucher interventions to increase uptake of cervical cancer screening in the Kilimanjaro and Arusha regions of Tanzania: a randomised, double-blind, controlled trial of effectiveness

BMJ Innovations ◽

10.1136/bmjinnov-2018-000276 ◽

2019 ◽

Vol 5 (1) ◽

pp. 28-34 ◽

Cited By ~ 8

Author(s):

Erica Erwin ◽

Kristan J Aronson ◽

Andrew Day ◽

Ophira Ginsburg ◽

Godwin Macheku ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Behaviour Change ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Behaviour Change Communication ◽

Change Communication ◽

Catchment Areas

BackgroundCervical cancer, although almost entirely preventable through cervical cancer screening (CCS) and human papillomavirus vaccination, is the leading cause of cancer deaths among women in Tanzania. Barriers to attending CCS include lack of awareness of CCS, affordability concerns regarding screening and travel cost. We aimed to compare the effectiveness of SMS (short message service) behaviour change communication (BCC) messages and of SMS BCC messages delivered with a transportation electronic voucher (eVoucher) on increasing uptake of CCS versus the control group.MethodsDoor-to-door recruitment was conducted between 1 February and 13 March 2016 in randomly selected enumeration areas in the catchment areas of two hospitals, one urban and one rural, in Northern Tanzania. Women aged 25–49 able to access a mobile phone were randomised using a computer-generated 1:1:1 sequence stratified by urban/rural to receive either (1) 15 SMS, (2) an eVoucher for return transportation to CCS plus the same SMS, or (3) one SMS informing about the nearest CCS clinic. Fieldworkers and participants were masked to allocation. All areas received standard sensitisation including posters, community announcements and sensitisation similar to community health worker (CHW) sensitisation. The primary outcome was attendance at CCS within 60 days of randomisation.FindingsParticipants (n=866) were randomly allocated to the BCC SMS group (n=272), SMS + eVoucher group (n=313), or control group (n=281), with 851 included in the analysis (BCC SMS n=272, SMS + eVoucher n=298, control group n=281). By day 60 of follow-up, 101 women (11.9%) attended CCS. Intervention group participants were more likely to attend than control group participants (SMS + eVoucher OR: 4.7, 95% CI 2.9 to 7.4; SMS OR: 3.0, 95% CI 1.5 to 6.2).Trial registration numberNCT02680613.

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Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus–Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15863 ◽

2020 ◽

Vol 22 (4) ◽

pp. e15863 ◽

Cited By ~ 1

Author(s):

Ditte S Linde ◽

Marianne S Andersen ◽

Julius Mwaiselage ◽

Rachel Manongi ◽

Susanne K Kjaer ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Intervention Group ◽

Text Messages ◽

Control Group ◽

Randomized Controlled ◽

Parallel Group

Background Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive. Objective This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. Methods This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. Results Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial—358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). Conclusions Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. Trial Registration ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702. International Registered Report Identifier (IRRID) RR2-10.2196/10.2196/15863

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Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

Clinical Rehabilitation ◽

10.1177/02692155211041104 ◽

2021 ◽

pp. 026921552110411

Author(s):

Hiromichi Takeda ◽

Katsuhiko Takatori

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Adherence ◽

Control Group ◽

Adult Day Care ◽

Control Groups ◽

Randomized Controlled ◽

And Control ◽

Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

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Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017730 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017730 ◽

Cited By ~ 5

Author(s):

João Firmino-Machado ◽

Romeu Mendes ◽

Amélia Moreira ◽

Nuno Lunet

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Population Based ◽

Text Messages ◽

Phone Call ◽

Face To Face ◽

Phone Calls ◽

And Control

IntroductionScreening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a—customised text message invitation; step 1b—customised automated phone call invitation; step 2—secretary phone call; step 3—family health professional phone call and face-to-face appointment.MethodsA population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses.Ethics and disseminationThe study was approved by the Ethics Committee of the Northern Health Region Administration and National Data Protection Committee. Results will be disseminated through communications in scientific meetings and peer-reviewed journals.Trial numberNCT03122275

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Outcomes of a Multicomponent Culturally Tailored Cervical Cancer Screening Intervention Among Underserved Hispanic Women (De Casa en Casa)

Health Promotion Practice ◽

10.1177/1524839919893309 ◽

2019 ◽

Vol 22 (1) ◽

pp. 112-121 ◽

Cited By ~ 2

Author(s):

Navkiran K. Shokar ◽

Jessica Calderon-Mora ◽

Jennifer Molokwu ◽

Theresa Byrd ◽

Adam Alomari ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

White Women ◽

Health Workers ◽

Hispanic Women ◽

Intervention Group ◽

Control Group ◽

Culturally Tailored ◽

Multiple Component

Hispanic women have almost double the cervical cancer incidence and are twice as likely to die from cervical cancer compared with non-Hispanic White women. Cervical cancer is preventable with screening, and based on available data, multiple component screening interventions have been proposed as a strategy to maximize screening, but such studies are lacking. We sought to test the effectiveness of a multicomponent screening intervention for primary prevention and early detection of cervical cancer among underserved Hispanic women. We conducted a prospective community-based cervical cancer screening intervention utilizing a quasi-experimental design. The intervention was theory based, delivered by bilingual community health workers, combined education and reduction of noneconomic barriers, and addressed economic barriers. Components included outreach, education, provision of no-cost Papanicolaou and human papillomavirus screening, on-site diagnostic and treatment colposcopy, and patient navigation with tracking to facilitate screening, diagnosis, and treatment. The main outcome was self-reported screening. We recruited 300 intervention group and 299 control group participants. Mean age of the sample was 44.7 years. The majority were Hispanic (98%), born in Mexico (79%), and had a Spanish-language preference (86%). In intention-to-treat analyses, the intervention group had a relative risk of screening of 14.58 (95% confidence interval = 8.57-24.80, p < .001) compared with the control group. A multilevel, multiple component culturally tailored bilingual cervical cancer screening intervention combining education, navigation, and no-cost screening can significantly increase cervical cancer screening uptake in a high-risk, underscreened population and has the potential to affect cervical cancer health disparities.

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Does the consumption of amylase-containing gruels impact on the energy intake and growth of Congolese infants?

Public Health Nutrition ◽

10.1079/phn2002428 ◽

2003 ◽

Vol 6 (3) ◽

pp. 249-257 ◽

Cited By ~ 26

Author(s):

M Moursi ◽

F Mbemba ◽

S Trèche

Keyword(s):

Breast Milk ◽

Energy Intake ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Milk Consumption ◽

Control Groups ◽

Daily Energy ◽

Randomised Controlled ◽

And Control

AbstractObjective:To assess the effect of the incorporation of amylase in maize-based flours prepared as gruels on the energy intake and growth of Congolese infants.Design:A randomised controlled trial. At 18 weeks of age, infants were randomised into either an intervention group, where they were provided with a maize/soya-based flour that contained amylase, or a control group, where they were provided with a similar flour that did not contain amylase.Setting:Urban borough of Poto-Poto in Brazzaville, The Congo.Subjects:Eighty infants (40 in each group) were randomised into intervention and control groups. Three infants in the intervention group and two controls subsequently dropped out.Results:At 24 weeks, the addition of amylase resulted in a significant increase in energy intake (in kJ kg-1day-1) from gruels (P=0.02) without affecting breast milk consumption. In contrast, total energy intake (in kJ kg-1day-1) did not differ significantly between groups (P=0.08). After adjustment for morbidity and previous growth, infants in the intervention group showed better growth in length during the trial (+0.22 cm month-1;P=0.04), especially between 24 and 31 weeks of age (+0.51 cm month-1;P>0.01). There were no differences in weight velocity between groups.Conclusions:The findings of this study suggest that the consumption of amylase-treated gruels allows an increase in energy intake from these gruels without affecting breast milk consumption but has no impact on total daily energy intake. However, if started after 6 months, it could be effective in preventing faltering of infant linear growth.

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The Effect of Interventional Program on Breastfeeding Self-Efficacy and Duration of Exclusive Breastfeeding in Pregnant Women in Ahvaz, Iran

International Scholarly Research Notices ◽

10.1155/2014/510793 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 6

Author(s):

Somayeh Ansari ◽

Parvin Abedi ◽

Shirin Hasanpoor ◽

Soheila Bani

Keyword(s):

Pregnant Women ◽

Exclusive Breastfeeding ◽

Self Efficacy ◽

Educational Program ◽

Controlled Trial ◽

Intervention Group ◽

Breastfeeding Duration ◽

Control Group ◽

Control Groups ◽

And Control

Objective. This study aimed to determine the effect of educational program on Breastfeeding self-efficacy and duration of exclusive breastfeeding in pregnant women in Ahvaz, Iran. Methods. This randomized controlled trial was conducted on 120 nulliparous pregnant women who tended to breastfeed. The primary self-efficacy scores of samples were measured using Faux and Dennis breastfeeding self-efficacy questionnaire. Women were randomly recruited into two intervention and control groups. Educational program (two training sessions, each lasted two hours) with two days interval was performed for intervention group. One month after delivery, self-efficacy scores were determined. Six months after child birth, duration of exclusive breastfeeding was assessed. Data were analyzed by means of descriptive and inferential statistics. Findings. The breastfeeding self-efficacy in the intervention group increased significantly compared to the control group one month after delivery (123.6 versus 101.7, P<0.001). The duration of exclusive breastfeeding was significantly higher in the intervention group (5.03 mo versus 2.7 mo, P<0.001). Also, there was a significant relationship between breastfeeding self-efficacy and duration of exclusive breastfeeding (P<0.001). Conclusion. The educational program could increase the self-efficacy and exclusive breastfeeding duration of mothers. These results can draw the attention of authorities to the importance of educational programs for mothers regarding the exclusive breastfeeding.

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