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NCT Number: NCT06710860

ScreenTalk to Improve Colorectal Cancer Screening Uptake Among First-degree Relatives of Patients: a Study Protocol

Participants in intervention group will receive the ScreenTalk intervention consisting of 3 module: measurement module, algorithmic tailoring module, and open dialogue module. The primary outcome, CRC screening uptake will be verified by medical records; and health belief will be measured at baseline, 3, 6, 9 and 12 months.

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Key information

Conditions

Colonoscopy Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms First-degree Relatives Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China

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About this study

This study will follow a hybrid type I effectiveness-implementation trial design. A cluster-randomized controlled trial will be conducted to examine the effectiveness of the intelligent voice-interactive tailored communication system. ScreenTalk can automatically tailor screening recommendations based on risk and psychosocial characteristic assessments by leveraging intelligent speech interaction (ISI) technology. The three components of the ScreenTalk intervention are as follows: (1) a measurement module, (2) an algorithmic tailoring module, and (3) an open dialogue module. All participants will be required to complete 3 modules within 1 month. If the intervention group does not undergo CRC screening at the follow-up time point, the system will repeatedly provide tailored communication intervention to further enhance the CRC risk perception of FDRs based on the current evaluation results. The implementation outcomes will be guided by the RE-AIM framework. Both qualitative and quantitative methods will be employed to evaluate implementation outcomes and determine the factors that may influence implementation process. CRC screening uptake verified by medical records and health belief will be measured at baseline, 3, 6, 9 and 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 to 75 years or 10 years before the age at which the relative was diagnosed;
  • individuals with one FDR with CRC age <60 years or with two or more FDRs with CRC at any age;
  • have not had a colonoscopy within 5 years;
  • access to WeChat themselves or through close family members living in the same household;
  • able to read and speak Chinese.

Exclusion criteria

  • Have history of cancer or inflammatory bowel disease;
  • have history of a hereditary syndromes (Lynch syndrome or familial adenomatous polyposis);
  • recently participate in another study or previously participated in cancer risk counseling or study;
  • with doctor-diagnosed psychiatric illness.

Treatment and study plan

The intelligent voice-interactive tailored communication system-based intervention

Behavioral

Participants in intervention group will receive the ScreenTalk intervention consisting of 3 modules:(1) a measurement module, (2) an algorithmic tailoring module, and (3) an open di-alogue module. All participants will be required to complete 3 modules within 1 month. If the intervention group does not undergo CRC screening at the follow-up time point, the system will repeatedly provide tailored communication intervention to further enhance the CRC risk perception of FDRs based on the current evaluation results. The primary outcome (uptake of CRC screening) will be measured at 3 months post-intervention (T1), 6 months post-intervention (T2), 9 months post-intervention (T3) and 12 months post-intervention (T4).

Primary outcomes

  1. Participate rate of CRC screening

    Time frame: 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

    Uptake of colonoscopy or FOBT. Medical records will be collected from those who had undergone colonoscopy or fecal test. Only the examination records that are verified by medical records will be counted and involved in the data analysis.

Secondary outcomes

  1. Perceived threat

    Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

    The Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR), with 6 dimensions, will be used to measures perceived threat of CRC and colonoscopy screening, namely per-ceived susceptibility of CRC and perceived severity of CRC. Each item of CCHBS-FDR is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 36 to 180. Higher scores on each dimension indicate higher levels of perception.

  2. Perceived efficacy

    Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

    Perceived efficacy includes perceived benefits and self-efficacy. The Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR) will be used to measures perceived efficacy of colonoscopy screening, and the four-item simplified Chinese version of the self-efficacy questionnaire will be used to assess the self-efficacy for participating in CRC screening. Each item of these two questionnaires is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 36 to 180. Higher scores on each dimension indicate higher levels of perception.

  3. Perceived barriers

    Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

    The Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR) will be used to measures perceived barriers for participating in CRC screening. Each item of CCHBS-FDR is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 36 to 180. Higher scores on each dimension indicate higher levels of perception.

  4. Cue to action

    Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

    Including three types of action cues: family history of CRC, physician's recommendation and health insurance coverage. The cue to action for CRC screening questionnaire will be used to collect information of cue to action among FDRs. Each item is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The score for cues to action was calculated by averaging the corresponding items (ranging from 1 to 5), with higher score indi-cating higher cue to action.

Other outcomes

  1. Participant characteristics

    Time frame: Baseline (T0)

    A self-designed general information questionnaire will be used to collect participant characteristics.

  2. Percentage of contacted FDRs who participate in this study

    Time frame: Baseline (T0); 1 month post-intervention

    Collect data through information recorded in the Implementation logbook

  3. Enrollment routes

    Time frame: Baseline (T0)

    Including the recruitment approach and reasons for refusal to participate. It will be collected through the implementation logbook.

  4. Representativeness of staff that participate

    Time frame: Baseline (T0)

    The self-designed general information questionnaire for staff will be used to collect related data.

  5. Barriers and facilitators to adoption

    Time frame: 13 months post-intervention

    Qualitative interviews will be conducted to gain staff insights into intervention adoption.

  6. Fidelity

    Time frame: 1 month post-intervention; post-implementation

    Fidelity includes participants' adherence of each module and reasons for non-completion. Relevant data will be collected through the tailored communication system record.

  7. Acceptability

    Time frame: 1-month post intervention

    The User Feedback Questionnaire for ScreenTalk will be used to measure the satisfaction among the participant for ScreenTalk.

  8. Maintenance

    Time frame: 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

    Sustained engagement of participants at 3-month, 6-month, 9-month, and 12-month follow-up. Follow-up information of participants will be obtained through the implementation logbook and tailored communication system record.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuya Lin

CONTACT

[email protected]

+86 13715154981

Yang Bai

CONTACT

[email protected]

+86 13922317606

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

An Intelligent Voice-interactive Tailored Communication System (ScreenTalk) for Enhancing Colorectal Cancer Screening Among First-degree Relatives of Patients: a Randomized Type I Hybrid Effectiveness-implementation Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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