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OpenTrials
Completed

NCT Number: NCT05479851

ORCA: Opportunities to Raise Cancer Awareness After Referral: Survey of Patient Views

The purpose of this study is to investigate what patients think about increasing provision of advice about how to detect cancer early and how to reduce their future cancer risk after they are discharged from a two-week wait referral pathway for suspected cancer. This study will send a postal survey to patients living in the UK who were recently referred onto the suspected cancer pathway and were discharged without a cancer diagnosis (i.e. a negative diagnosis). Patients will be presented with different types of support and patients' views of the burden, benefits, understanding and perceived effectiveness of each one will be measured.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College London

London, Surrey, RH8 0NR, United Kingdom

About this study

In England, over 2 million patients are referred each year on urgent two-week wait (TWW) pathways to rule-out cancer of a single anatomical site. Referrals have increased by around 10% per year since 2015 (with the exception of 2020, due to the COVID-19 pandemic). The vast majority of those referred (93%) do not have cancer diagnosed. There is mounting evidence that patients who have previously experienced a symptom that after investigation turned out to be benign, often delay seeking help for subsequent symptoms. This is thought to occur because of over-reassurance from the previous 'all-clear' result leading to subsequent symptoms being interpreted as benign (extending the appraisal interval), concern about appearing hypochondriacal, not wanting to further bother the doctor or about the appropriate next actions. This is likely to be compounded by the impact of COVID-19 on help-seeking decisions and has implications for service provision. There may be scope to provide tailored support to those who are initially discharged without a cancer diagnosis to avoid missing cancers at other anatomical sites and to ensure subsequent cancers are diagnosed in a timely manner, at an early stage, or even prevented. For instance, patients could be offered information on common cancer signs, when/how to seek help for ongoing or new symptoms, facilitation to take part in cancer screening, and preventative advice. Indeed, referral for suspected cancer may be an under-utilised 'teachable moment' when people are more responsive and receptive to health information. There is currently a lack of support for those with a negative diagnosis after a TWW referral. Qualitative work indicates that there is currently no standardised approach to the information patients receive from healthcare professionals about future cancer risk or how to respond to new or recurring symptoms. It is important to assess feasibility and acceptability of interventions prior to evaluation of effectiveness. This allows implementation strategies to be incorporated into the design of interventions that will increase adoption and sustainment as well as being appropriate to the setting, providers and recipients. Yet at present it is not known what the feasibility and acceptability is of interventions linked to the TWW pathway. The objective of the proposed research is to obtain this information.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults >18 years old
  • Referred through the two-week wait pathway for suspected cancer
  • Received a negative diagnosis (i.e. informed of a 'ruling out of cancer' according to the new 28-day faster diagnosis standard) within the past 1-3 months

Exclusion criteria

  • Adults who have been diagnosed with cancer
  • Adults who have not yet been informed of their results from their urgent referral

Treatment and study plan

Primary outcomes

  1. Participants' prospective acceptability ratings of different types of cancer advice and support interventions using a thirteen-item scale

    Time frame: cross sectional questionnaire to be completed 1-3 months after urgent referral

    Prospective acceptability (perceived acceptability prior to intervention participation) of different cancer advice and support interventions, will be compared using scores obtained from a 13-item scale reflecting the domains of the Theoretical Framework of Acceptability (Scott et al 2021).

Secondary outcomes

  1. Proportions of participants willing to receive each type of advice/ support, after discharge from a two week wait (urgent referral) pathway

    Time frame: cross sectional questionnaire to be completed 1-3 months after urgent referral

    Comparison of the willingness of participants from different two week wait pathways to receive different types of advice/ support. Willingness will be assessed using a one-item measure (Stevens et al 2019, Prev Med; Stevens et al, 2019, Lung Cancer).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Acronym: ORCA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Jun 15, 2023

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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