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| ID | Type | Description | Link |
|---|---|---|---|
| MR/W023903/1 | Other Grant/Funding Number | Medical Research Council (MRC) |
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| Name | Class |
|---|---|
| Adyar Cancer Institute, WIA, Chenni, India | UNKNOWN |
| Department of Public Health and Preventive Medicine (DPH & PM), Chennai, India | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lived experience video campaign | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 6 months |
| Examination coverage in both arms | The proportion of individuals eligible for screening who participated in the screening program. | 6 months |
| Further assessment coverage in both arm | The proportion of individuals who participated in the cancer screening program requiring further assessment. | 6 months |
| Detection of cancers in both arms | The proportion of individuals eligible for screening who are diagnosed with cancers. | 6 months |
| Treatment referral in both arms | The proportion of individuals eligible for screening who are referred for treatment to higher centres. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation research outcomes - Reach | Proportion of eligible men and women who received the intervention. | 6 months |
| Implementation research outcomes - Effectiveness | Proportion of eligible men and women who agreed to participate in the existing cancer screening program. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T.S. Selvavinayagam, MD | Department of Public Health and Preventive Medicine | Principal Investigator |
| Jerard Maria Selvam | National Health Mission-Tamil Nadu | Principal Investigator |
| K. Krishnaraj | Department of Public Health and Preventive Medicine | Principal Investigator |
| Vidhya Viswanathan | Department of Public Health and Preventive Medicine | Principal Investigator |
| N.V. Vani, PhD | Cancer Institute (WIA), Chennai | Principal Investigator |
| R. Swaminathan, PhD | Cancer Institute (WIA), Chennai, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adyar cancer institute | Chennai | Tamil Nadu | 600020 | India |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D001943 | Breast Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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
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| 6 months |
| Implementation research outcomes - Acceptability | Proportion of eligible men and women who find the intervention (Lived experience campaign video) to be acceptable. | 6 months |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006258 | Head and Neck Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |