A study protocol for a randomised controlled community trial assessing efficacy of the AWACAN-ED public toolkit to improve cancer symptom awareness and intention to seek help in South Africa and Zimbabwe

Advancing Early Diagnosis of Cancer in Southern Africa - the African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) program – evaluation of public interventions

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202505475803308

Enrollment

432

Registered

2025-05-28

Start date

2025-05-12

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Alternative intervention

Breast cancer intervention group

Cervical cancer intervention group

Colorectal cancer intervention group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 years old or over - Reside in the selected study areas.

Exclusion criteria

Exclusion criteria: - Previous self-reported diagnosis of breast, cervical or colorectal cancer. - Unable to communicate in English, Afrikaans, isiXhosa, Ndebele or Shona. - Unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Recall of symptoms. To assess recall of symptoms, an open-ended question will be used: “Please would you name as many symptoms or signs of [breast, cervical, or colorectal] cancer as you can think of?”. Responses will be recorded verbatim and will be coded by two researchers in each country against the list of agreed symptoms in the AWACAN-ED survey instruments. Participants will score ‘1’ if they mention a symptom that corresponds to the list of symptoms, and ‘0’ if they do not mention it and summed to produce total score of the number of recalled symptoms.	—

Measure

Time frame

Recall of symptoms. To assess recall of symptoms, an open-ended question will be used: “Please would you name as many symptoms or signs of [breast, cervical, or colorectal] cancer as you can think of?”. Responses will be recorded verbatim and will be coded by two researchers in each country against the list of agreed symptoms in the AWACAN-ED survey instruments. Participants will score ‘1’ if they mention a symptom that corresponds to the list of symptoms, and ‘0’ if they do not mention it and summed to produce total score of the number of recalled symptoms.

—

Secondary

Measure	Time frame
Intention to seek help. It will be measured by asking participants to report how soon they would visit the pharmacy or clinic or health centre or hospital, if they noticed symptoms of possible breast, cervical and colorectal cancer with 5 response options (“never”, “less than one week,”, “between a week and one month”, “between a month and three months”, and “three months or more”). Only women will be asked the items about seeking help for breast or cervical symptoms. For analysis, responses will be dichotomised to ‘less than one week’ and ‘more than one week’. ;Emotional impact. To assess the emotional impact of the AWACAN-ED public tools, we will measure state anxiety which is defined as a transitory emotional response to a specific situation. A measure of emotional response to cancer symptoms that has previously been used in the African context was adapted for this study. The scale contains four items on feeling anxious, distressed, concerned, and afraid. The participants select from three response options (“No, not at all”, “Yes, a bit”, “Yes a lot”) which are assigned numerical values (1-3). These values are summed to calculate an anxiety score. Higher scores indicate higher levels of state anxiety. This state anxiety measure will be administered prior to the intervention (T0) and in the first post-intervention questionnaire (T1).;Acceptability of the tools. Participants will be asked how engaging they found the AWACAN-ED tool across five aspects of engagement (appealing, unpleasant, interesting, hard to understand, informative) adapted from previous studies. Response options will include “Agree”; “disagree” and “Don’t know”. Participants will have the opportunity to add further comments or suggestions regarding the AWACAN-ED tool. Responses will be recorded verbatim. These items will only be asked in the first post-intervention questionnaire (T1).	—

Measure

Time frame

Intention to seek help. It will be measured by asking participants to report how soon they would visit the pharmacy or clinic or health centre or hospital, if they noticed symptoms of possible breast, cervical and colorectal cancer with 5 response options (“never”, “less than one week,”, “between a week and one month”, “between a month and three months”, and “three months or more”). Only women will be asked the items about seeking help for breast or cervical symptoms. For analysis, responses will be dichotomised to ‘less than one week’ and ‘more than one week’. ;Emotional impact. To assess the emotional impact of the AWACAN-ED public tools, we will measure state anxiety which is defined as a transitory emotional response to a specific situation. A measure of emotional response to cancer symptoms that has previously been used in the African context was adapted for this study. The scale contains four items on feeling anxious, distressed, concerned, and afraid. The participants select from three response options (“No, not at all”, “Yes, a bit”, “Yes a lot”) which are assigned numerical values (1-3). These values are summed to calculate an anxiety score. Higher scores indicate higher levels of state anxiety. This state anxiety measure will be administered prior to the intervention (T0) and in the first post-intervention questionnaire (T1).;Acceptability of the tools. Participants will be asked how engaging they found the AWACAN-ED tool across five aspects of engagement (appealing, unpleasant, interesting, hard to understand, informative) adapted from previous studies. Response options will include “Agree”; “disagree” and “Don’t know”. Participants will have the opportunity to add further comments or suggestions regarding the AWACAN-ED tool. Responses will be recorded verbatim. These items will only be asked in the first post-intervention questionnaire (T1).

—

Countries

South Africa, Zimbabwe

Contacts

Public ContactBothwell Takaingofa Guzha

Lecturer Department of Obstetrics and Gynaecology University of Harare

bguzha@uz-ctrc.org+263772287143

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026