An interventional study of SMS invitation and Phone call invitation in Cervical Cancer and Human Papilloma Virus, sponsored by Institut Català d'Oncologia. Status unknown at 1 site in Spain. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Institut Català d'Oncologia · Not applicable, Interventional, and Other
A study on two different methods of invitation to participate to the cervical cancer screening programme will be conducted within a demonstration project to switch from cytology-based screening to HPV-based screening using self-sampling delivered through the network of pharmacy offices among regular screening attendants in the Barcelona Metropolitana Sud Area, in Catalonia.
At the moment, eligible women are invited to participate to cervical cancer screening via a telephone call invitation explaining the new self-sampling method. Invitation via SMS containing a link to a webpage with information on most frequent questions might be an adequate alternative method that would save costs and workload on human resources.
The aim of this study is to assess the impact on cervical cancer screening participation of an invitation method based on text messaging (SMS).
The invitation method will be evaluated through an interventional trial, in which we will compare the invitation to cervical cancer screening using SMS versus a telephone call invitation explaining the new self-sampling method.
Main Hypothesis:
The use of direct SMS without an explanatory call for cervical cancer screening invitation is an acceptable option to invite women if the participation obtained is more than 70% and not less than 15% of the call (current practice).
Specific Hypothesis:
Sample size calculation:
A one-sample non-inferiority test for calculating sample size was performed, assuming a participation rate of 80% using SMS invitation and 85% using telephone call invitation in the cervical cancer screening programme. To detect a participation rate using SMS or telephone call invitation non-inferior to 70%, with a margin of 5%, accepting an alpha risk of 0.025 and a beta risk of 0.2, and 5% of loses of follow-up, we will need 27 women in the telephone call group and 59 women in the SMS group. To observe this non-inferiority by age group (≤40 years, 41-54 years, ≥55 years), 27 and 59 women will be needed for each age group.
To compare both study arms, a two-sample non-inferiority test was performed assuming that using SMS messages to invite women to participate in cervical cancer screening programme will be 5% lower compared to participation when invitation is performed by a phone call (80% versus 85% respectively), although this difference will be non-inferior to 15-15.5%. Thus, if there is a true difference in favor of the telephone call group of 5%, assuming 5% of loses of follow-up, then 450 women will be required (225 in each arm) to be 80% sure that the upper limit of a one-sided 97.5% confidence interval will exclude a difference in favor of the SMS group of more than 15-15.5%.
Randomization procedure:
Women will be randomized in two study arms: intervention (SMS message invitation) and control (telephone call invitation). Randomization will be performed based on permuted blocks of 6 women to ensure equal distribution among age groups.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 450 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Institut Català d'Oncologia is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SMS invitation to participate in cervical cancer screening using HPV self-sampling.
Behavioral: SMS invitation
Phone call invitation to participate in cervical cancer screening using HPV self-sampling.
Behavioral: Phone call invitation
Behavioral: SMS to invite to cervical cancer screening using HPV self-sampling.
Behavioral: Phone call to invite to cervical cancer screening using HPV self-sampling.
Participation in cervical cancer screening program
Participation (no/yes) in cervical cancer screening program will be gathered prospectively 12 weeks after sending the screening invitation (day 0).
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Institut Català d'Oncologia