Cervical CancersNCT06874985
Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Screening Participation
A study testing Lived experience video campaign in people with Cervical Cancers and Breast Cancer, run by International Agency for Research on Cancer at 1 site in India.
Trial summary
This study will be conducted as a parallel-arm, open-label, randomized controlled trial (RCT) to evaluate the effectiveness and impact of the Lived Experience Communication Campaign (LECC) on cancer screening participation rates [oral, breast and cervical cancer] compared to the usual standard awareness campaign… Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancers, Breast Cancer, Oral Cancer
- What is being tested?
- Lived experience video campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,264 participants
- Where
- 1 siteIndia
- Study dates
- 5 May 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 30-59 years
- No prior diagnosis of cervical, breast, or oral cancer.
- Have not undergone screening for the above cancers in the last 1 year
- Provide informed consent to participate
Who cannot join
- Individuals with a previous history of any cancer
- Individuals with severe cognitive impairments that prevent comprehension of study materials
- Participants unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Participation in the Existing Cancer Screening Programs [Oral, Breast and Cervical] Among the Rural Population in Villupuram District, Tamil Nadu
This study will be conducted as a parallel-arm, open-label, randomized controlled trial (RCT) to evaluate the effectiveness and impact of the Lived Experience Communication Campaign (LECC) on cancer screening participation rates [oral, breast and cervical cancer] compared to the usual standard awareness campaign across selected rural population in Villupuram district, Tamil Nadu.
Read the detailed description
The Access Cancer Care India (ACCI) project is aimed at designing and evaluating an evidence-based multi-level strategy tailored to the local health system to enhance access to early detection and care continuum for oral, breast, and cervical cancers among rural populations in India, who are socioeconomically disadvantaged and vulnerable to huge inequity in cancer care.
Pre-intervention phase:
The pre-intervention assessment was conducted in four blocks (Vanur, Mailam, Vikravandi, Kanai) in Viluppuram District, Tamil Nadu, between August 2023 and July 2024 to understand the barriers and challenges rural men and women face in accessing cancer early detection care continuum using various methods.
- Questionnaire survey of breast, cervical, and oral cancer patients and the general population
- Focus group discussions with the general population and community health workers
- In-depth interviews with key informants
- Capacity assessment The results of the preintervention highlighted that fear, stigma, limited accessibility to screening, miscommunication and lack of family support were vital barriers that influenced cancer care access in Tamil Nadu. Thus, we decided to design and implement evidence based cultural relevant intervention, pilot test and evaluate them. In order to target the component of fear, stigma and accessibility issues, we decided to design and implement a Lived life communication campaign and test it as an RCT across selected blocks of Tamil Nadu. The rationale for proposing a parallel-arm RCT for this intervention is to assess its effectiveness specifically within the Indian context. While the "lived experience" campaign has been successfully implemented in other Asian populations, its impact in India remains untested. A parallel-arm RCT design enables comparison across the intervention and control arm on specific screening program outcomes. This approach ensures a comprehensive assessment of the intervention's effectiveness in improving screening uptake among the target population. The findings will provide robust evidence to either validate or improve the intervention, tailoring it to the unique needs of the Indian setting. This study evaluates the effectiveness of the Lived Experience Communication Campaign (LECC) in increasing participation in cancer screening programs for oral, breast, and cervical cancer among rural populations in Villupuram district, Tamil Nadu. Conducted as a parallel-arm, open-label, randomized controlled trial (RCT), the study compares LECC to standard awareness campaigns. Randomisation was at the level of the block using cointoss, where Mailam block serves as the intervention site, while Vanur block serves as the control. Eligible participants (men and women aged 30-59 years without prior cancer diagnoses or recent screenings) will be randomly selected using systematic sampling. The intervention comprises a culturally relevant two-minute awareness video featuring personal survivor narratives, delivered door-to-door by community health workers. Standard awareness campaigns are conducted in the control arm. Baseline data on cancer screening participation is collected from healthcare records. Follow-up assessments are conducted monthly for six months, measuring screening participation rates and other program indicators. Evaluation follows the RE-AIM framework, examining effectiveness, feasibility, and acceptability. Results will inform future policy decisions on implementing lived experience campaigns to enhance cancer screening uptake in India.
- Conditions
- Cervical Cancers, Breast Cancer, Oral Cancer
- Being tested
- Lived experience video campaign
- Keywords
- Lived Experience Communication Campaign, Randomised control trial, Cancer screening, Public Health intervention, Access Cancer Care India
- Medical subject headings
- Uterine Cervical Neoplasms, Breast Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lived experience video campaignBehavioural
Participants in the selected villages will be shown a two-minute video developed specifically for the Lived Experience Communication Campaign in addition to usual awareness they receive for cancer screening mobilisation. The video will feature personal narratives from cancer survivors and local leaders emphasizing the importance of early detection and screening.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants in the selected villages will be shown a two-minute video developed specifically for the Lived Experience Communication Campaign in addition to usual awareness they receive for cancer screening mobilisation. The video will feature personal narratives from cancer survivors and local leaders emphasizing the importance of early detection and screening. Receives: Behavioral: Lived experience video campaign |
| Control arm | No intervention | Participants will receive standard cancer awareness campaigns conducted by community health workers as per existing healthcare practices. No additional materials or interventions will be provided beyond routine awareness programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Participation Rate
The proportion of eligible participants who visited a healthcare center for cervical, breast, or oral cancer screening within one month of the intervention (or usual care in the control group).
Measured: 1 month after the participation
Invitation coverage in both arms
The proportion of eligible individuals living in the intervention and control villages covered through invitations for cancer screening.
Measured: 6 months
Examination coverage in both arms
The proportion of individuals eligible for screening who participated in the screening program.
Measured: 6 months
Further assessment coverage in both arm
The proportion of individuals who participated in the cancer screening program requiring further assessment.
Measured: 6 months
Detection of cancers in both arms
The proportion of individuals eligible for screening who are diagnosed with cancers.
Measured: 6 months
Treatment referral in both arms
The proportion of individuals eligible for screening who are referred for treatment to higher centres.
Measured: 6 months
Secondary outcomes (3)
Implementation research outcomes - Reach
Proportion of eligible men and women who received the intervention.
Measured: 6 months
Implementation research outcomes - Effectiveness
Proportion of eligible men and women who agreed to participate in the existing cancer screening program.
Measured: 6 months
Implementation research outcomes - Acceptability
Proportion of eligible men and women who find the intervention (Lived experience campaign video) to be acceptable.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start5 May 2025
- Primary completion31 Jan 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Since cluster or individual randomization was not feasible due to the risk of contamination, a simple randomization strategy was employed at the block-level. A coin flip \[doe by the investigator team at IARC\] identified which block would receive the intervention (Mailam) and which would serve as the control (Vanur). However, all the baseline characteristics and demographics will be collected from both the participants in both villages and would be compared to ensure
- Masking
- None (open label)
- Enrolment
- 1,264 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Adyar Cancer Institute, WIA, Chenni, India, Department of Public Health and Preventive Medicine (DPH & PM), Chennai, India
- Responsible party
- Principal investigator, Partha Basu, International Agency for Research on Cancer
- Investigators
- T.S. Selvavinayagam, MD, Principal investigator, Department of Public Health and Preventive MedicineJerard Maria Selvam, Principal investigator, National Health Mission-Tamil NaduK. Krishnaraj, Principal investigator, Department of Public Health and Preventive MedicineVidhya Viswanathan, Principal investigator, Department of Public Health and Preventive MedicineN.V. Vani, PhD, Principal investigator, Cancer Institute (WIA), ChennaiR. Swaminathan, PhD, Principal investigator, Cancer Institute (WIA), Chennai, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874985
- Sponsor's protocol ID
- IEC 22-05
- Other IDs
- MR/W023903/1
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Participation in the Existing Cancer Screening Programs [Oral, Breast and Cervical] Among the Rural Population in Villupuram District, Tamil Nadu
- ClinicalTrials.gov ID
- NCT06874985
- Acronym / sponsor ID
- IEC 22-05
- Conditions
- Cervical Cancers, Breast Cancer, Oral Cancer
- Keywords
- Lived Experience Communication Campaign, Randomised control trial, Cancer screening, Public Health intervention, Access Cancer Care India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,264 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Adyar Cancer Institute, WIA, Chenni, India, Department of Public Health and Preventive Medicine (DPH & PM), Chennai, India
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted as a parallel-arm, open-label, randomized controlled trial (RCT) to evaluate the effectiveness and impact of the Lived Experience Communication Campaign (LECC) on cancer screening participation rates [oral, breast and cervical cancer] compared to the usual standard awareness campaign across selected rural population in Villupuram district, Tamil Nadu.
Detailed description
The Access Cancer Care India (ACCI) project is aimed at designing and evaluating an evidence-based multi-level strategy tailored to the local health system to enhance access to early detection and care continuum for oral, breast, and cervical cancers among rural populations in India, who are socioeconomically disadvantaged and vulnerable to huge inequity in cancer care.
Pre-intervention phase:
The pre-intervention assessment was conducted in four blocks (Vanur, Mailam, Vikravandi, Kanai) in Viluppuram District, Tamil Nadu, between August 2023 and July 2024 to understand the barriers and challenges rural men and women face in accessing cancer early detection care continuum using various methods.
- Questionnaire survey of breast, cervical, and oral cancer patients and the general population
- Focus group discussions with the general population and community health workers
- In-depth interviews with key informants
- Capacity assessment The results of the preintervention highlighted that fear, stigma, limited accessibility to screening, miscommunication and lack of family support were vital barriers that influenced cancer care access in Tamil Nadu. Thus, we decided to design and implement evidence based cultural relevant intervention, pilot test and evaluate them. In order to target the component of fear, stigma and accessibility issues, we decided to design and implement a Lived life communication campaign and test it as an RCT across selected blocks of Tamil Nadu. The rationale for proposing a parallel-arm RCT for this intervention is to assess its effectiveness specifically within the Indian context. While the "lived experience" campaign has been successfully implemented in other Asian populations, its impact in India remains untested. A parallel-arm RCT design enables comparison across the intervention and control arm on specific screening program outcomes. This approach ensures a comprehensive assessment of the intervention's effectiveness in improving screening uptake among the target population. The findings will provide robust evidence to either validate or improve the intervention, tailoring it to the unique needs of the Indian setting. This study evaluates the effectiveness of the Lived Experience Communication Campaign (LECC) in increasing participation in cancer screening programs for oral, breast, and cervical cancer among rural populations in Villupuram district, Tamil Nadu. Conducted as a parallel-arm, open-label, randomized controlled trial (RCT), the study compares LECC to standard awareness campaigns. Randomisation was at the level of the block using cointoss, where Mailam block serves as the intervention site, while Vanur block serves as the control. Eligible participants (men and women aged 30-59 years without prior cancer diagnoses or recent screenings) will be randomly selected using systematic sampling. The intervention comprises a culturally relevant two-minute awareness video featuring personal survivor narratives, delivered door-to-door by community health workers. Standard awareness campaigns are conducted in the control arm. Baseline data on cancer screening participation is collected from healthcare records. Follow-up assessments are conducted monthly for six months, measuring screening participation rates and other program indicators. Evaluation follows the RE-AIM framework, examining effectiveness, feasibility, and acceptability. Results will inform future policy decisions on implementing lived experience campaigns to enhance cancer screening uptake in India.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Since cluster or individual randomization was not feasible due to the risk of contamination, a simple randomization strategy was employed at the block-level. A coin flip [doe by the investigator team at IARC] identified which block would receive the intervention (Mailam) and which would serve as the control (Vanur). However, all the baseline characteristics and demographics will be collected from both the participants in both villages and would be compared to ensure
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Lived experience video campaignParticipants in the selected villages will be shown a two-minute video developed specifically for the Lived Experience Communication Campaign in addition to usual awareness they receive for cancer screening mobilisation. The video will feature personal narratives from cancer survivors and local leaders emphasizing the importance of early detection and screening. |
| Control arm | No intervention | –Participants will receive standard cancer awareness campaigns conducted by community health workers as per existing healthcare practices. No additional materials or interventions will be provided beyond routine awareness programs. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women aged 30-59 years
- No prior diagnosis of cervical, breast, or oral cancer.
- Have not undergone screening for the above cancers in the last 1 year
- Provide informed consent to participate
Key exclusion criteria (3 listed)
- Individuals with a previous history of any cancer
- Individuals with severe cognitive impairments that prevent comprehension of study materials
- Participants unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lived experience video campaignParticipants in the selected villages will be shown a two-minute video developed specifically for the Lived Experience Communication Campaign in addition to usual awareness they receive for cancer screening mobilisation. The video will feature personal narratives from cancer survivors and local leaders emphasizing the importance of early detection and screening. | Behavioural | Intervention arm |
Primary outcome
Screening Participation Rate
Time frame: 1 month after the participation
The proportion of eligible participants who visited a healthcare center for cervical, breast, or oral cancer screening within one month of the intervention (or usual care in the control group).
Invitation coverage in both arms
Time frame: 6 months
The proportion of eligible individuals living in the intervention and control villages covered through invitations for cancer screening.
Examination coverage in both arms
Time frame: 6 months
The proportion of individuals eligible for screening who participated in the screening program.
Further assessment coverage in both arm
Time frame: 6 months
The proportion of individuals who participated in the cancer screening program requiring further assessment.
Detection of cancers in both arms
Time frame: 6 months
The proportion of individuals eligible for screening who are diagnosed with cancers.
Treatment referral in both arms
Time frame: 6 months
The proportion of individuals eligible for screening who are referred for treatment to higher centres.
3 secondary outcomes
Implementation research outcomes - Reach
Time frame: 6 months
Implementation research outcomes - Effectiveness
Time frame: 6 months
Implementation research outcomes - Acceptability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T.S. Selvavinayagam, MD principal investigator
Department of Public Health and Preventive Medicine
Jerard Maria Selvam principal investigator
National Health Mission-Tamil Nadu
K. Krishnaraj principal investigator
Department of Public Health and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lived experience video campaign in people with Cervical Cancers and Breast Cancer, run by International Agency for Research on Cancer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Participation Rate (time frame: 1 month after the participation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.