Breast CancerMini-AFTERcNCT03763825
Mini-AFTERc Intervention for Fear of Cancer Recurrence
A study testing Mini-AFTERc in people with Breast Cancer and Fear of Cancer, run by University of St Andrews at 4 sites in United Kingdom.
Trial summary
People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fear of Cancer
- What is being tested?
- Mini-AFTERc
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 13 Jun 2019to 1 Sep 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Patient inclusion criteria for screening:
- Completed primary cancer treatment.
- Cancer-free.
- Female.
- Responsible clinician agrees to their participation.
Patient inclusion criteria for trial:
- Score 'moderate' (≥10 and <15) on the Fear of Cancer Recurrence 4-item scale (FCR4) during screening.
Patient exclusion criteria:
- Not completed primary cancer treatment.
- Not cancer-free.
- Male.
- A diagnosed psychotic disorder, known to the cancer service, for which the patient is currently receiving treatment.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Queen Margaret Hospital
Dunfermline, NHS Fife, KY12 0SU
Western General Hospital
Edinburgh, NHS Lothain, EH4 2XU
Raigmore Hospital
Inverness, NHS Highlands, IV2 3UJ
Perth Royal Infirmary
Perth, NHS Tayside, PH1 1NX
About this study
Official title: A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients
People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to determine the acceptability and practicality of introducing the Mini-AFTERc intervention into everyday practice, and inform the development of a full randomised controlled trial.
Read the detailed description
The objectives of this pilot trial are as follows:
- To develop a procedure for training breast cancer nurses (BCN) in the delivery of the Mini-AFTERc intervention and introduce the intervention into current NHS service provision for breast cancer patients.
- To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer patients), the fidelity of intervention elements, the acceptability to participants (primary and secondary outcomes) and detailed economic indicators for a full trial.
- Apply a formal decision making framework (ADePT) to determine a profile of factors to reveal potential difficulties and appraise solutions prior to a full trial.
This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will take place in 4 breast cancer centres in NHS Scotland health boards, including Fife, Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian) and 2 centres will deliver usual care to patients, acting as control centres (Highlands and Tayside). The project will be delivered in 3 phases:
Phase 1 will include the development and delivery of the Mini-AFTERc intervention training package for breast cancer nurses.
Phase 2 will include patient recruitment and data collection. There will be 2 intervention centres and 2 control centres across NHS Scotland. Patients who have completed their primary breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and <15 on the Fear of Cancer Recurrence 4-item Scale; FCR4). Breast cancer nurses will deliver the intervention by telephone in intervention centres, which will be audio recorded. Patients will complete a satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control group. Semi-structured interviews with 20% of patients and all nurses will be conducted to assess experiences and acceptability of the intervention.
Phase 3 will conduct data analysis and trial evaluation. Screening and follow-up data will be quantitatively analysed, including structured equation modelling. Interviews will be subject to framework analysis based on normalisation process theory (NPT). The pilot trial will be systematically evaluated using a process of decision making after pilot and feasibility trials (ADePT).
The findings will help to understand if this brief intervention can be implemented in everyday practice and can reduce FCR. They will also inform the practicality of implementation of a larger-scale randomised trial.
- Conditions
- Breast Cancer, Fear of Cancer
- Being tested
- Mini-AFTERc
- Keywords
- fear of recurrence, cancer, brief intervention, telephone counselling, following primary cancer treatment
- Medical subject headings
- Breast Neoplasms, Pathophobia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-AFTERcBehavioural
Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment. Receives: Behavioral: Mini-AFTERc |
| Control group | No intervention | Patients will receive usual care after completion of primary breast cancer treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with nurse communication during the Mini-AFTERc intervention
Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.
Measured: 1 week post intervention
Secondary outcomes (8)
Fear of cancer recurrence level - FCR4
The FCR4 is a 4-item measure designed to assess patient anxiety, worry and strong feelings associated with the return of cancer (e.g. 'I am afraid that my cancer may recur'). The research group has validated the FCR4 as an accurate measure of cancer recurrence fears in breast cancer patients that is fit for routine use in clinical services (Humphris, Watson, Sharpe, \& Ozakinci, 2018). Each question in the FCR4 is rated by the patient on a scale of 1 ('Not at all') to 5 ('All the time'). A cumulative score of ≥10 (60 Percentile) across all 4 items is defined as 'moderate' fear of cancer recurrence and a cumulative score of ≥15 is defined as 'high' fear of cancer recurrence.
Measured: 3 months
Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item assessment tool used to screen for anxiety and depression the general medical population (Zigmond \& Snaith, 1983). The HADS is well established tool and has been employed in a multitude of medical settings, including oncology, to assess patients' mental health (Hartung et al., 2017; Vodermaier \& Millman, 2011). The HADS assesses two domains, depressionand anxiety. Patients report symptoms of depression and anxiety in the last week on a 4-point Likert scale, from 0 (e.g. "Not at all") to 3 (e.g. "Most of the time").
Measured: 3 months
Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)
The EQ-5D is a standardised instrument of health-related quality of life, developed by the EuroQol Group (Herdman et al., 2011). The EQ-5D assesses 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D contains 6-items, 5 of these items assess each of the 5 dimensions and are rated on a 5-level (5L) scale. The final item is a measure of health state, which is rated on a scale of 0 ('worst imaginable health state') to 100 (Best imaginable health state').
Measured: 3 months
Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of breast cancer nurses. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).
Measured: Within 1 month of delivering final intervention
Recruitment rate
Assess number of patients recruited at each site, including those who decline to participate.
Measured: Duration of the pilot trial (Approx 2 years)
Retention rate
Assess number of patients who complete the trial.
Measured: Duration of the pilot trial (Approx 2 years)
Attrition rate
Assess number of patients who do not complete the trial, withdraw or drop-out.
Measured: Duration of the pilot trial (Approx 2 years)
Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of patients. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).
Measured: Within 1 month of final follow-up questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start13 Jun 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St Andrews
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stirling, University of Surrey, Swansea University, Chief Scientist Office of the Scottish Government
- Responsible party
- Principal investigator, Prof G Humphris, University of St Andrews
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763825
- Sponsor's protocol ID
- 249571
- Acronym
- Mini-AFTERc
- Status last verified
- Dec 2018
- First submitted
- 23 Oct 2018
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davidson J, Malloch M, Humphris G. A single-session intervention (the Mini-AFTERc) for fear of cancer recurrence: A feasibility study. Psychooncology. 2018 Nov;27(11):2668-2670. doi: 10.1002/pon.4724. Epub 2018 Apr 30. No abstract available.
PubMed 29624779Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018 Feb 9;16(1):30. doi: 10.1186/s12955-018-0850-x.
PubMed 29471823Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
PubMed 15528286Cruickshank S, Steel E, Fenlon D, Armes J, Scanlon K, Banks E, Humphris G. A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol. Pilot Feasibility Stud. 2017 Jul 20;4:22. doi: 10.1186/s40814-017-0161-8. eCollection 2018.
PubMed 28748105Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751.
PubMed 18492319Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.
PubMed 24160371Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
PubMed 20961442Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Mehnert A. The Hospital Anxiety and Depression Scale (HADS) and the 9-item Patient Health Questionnaire (PHQ-9) as screening instruments for depression in patients with cancer. Cancer. 2017 Nov 1;123(21):4236-4243. doi: 10.1002/cncr.30846. Epub 2017 Jun 27.
PubMed 28654189Vodermaier A, Millman RD. Accuracy of the Hospital Anxiety and Depression Scale as a screening tool in cancer patients: a systematic review and meta-analysis. Support Care Cancer. 2011 Dec;19(12):1899-908. doi: 10.1007/s00520-011-1251-4. Epub 2011 Sep 4.
PubMed 21898134Brandt NG, McHale CT, Humphris GM. Development and Testing of a Novel Measure to Assess Fidelity of Implementation: Example of the Mini-AFTERc Intervention. Front Psychol. 2020 Nov 25;11:601813. doi: 10.3389/fpsyg.2020.601813. eCollection 2020.
PubMed 33324299McHale CT, Cruickshank S, Torrens C, Armes J, Fenlon D, Banks E, Kelsey T, Humphris GM. A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer. Pilot Feasibility Stud. 2020 May 7;6:60. doi: 10.1186/s40814-020-00610-4. eCollection 2020.
PubMed 32399254
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03763825
- Acronym / sponsor ID
- Mini-AFTERc / 249571
- Conditions
- Breast Cancer, Fear of Cancer
- Keywords
- fear of recurrence, cancer, brief intervention, telephone counselling, following primary cancer treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- University of St AndrewsUniversity, hospital or other
- Collaborators
- University of Stirling, University of Surrey, Swansea University, Chief Scientist Office of the Scottish Government
- Study start
- 13 Jun 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 4 Dec 2018 (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.
People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to determine the acceptability and practicality of introducing the Mini-AFTERc intervention into everyday practice, and inform the development of a full randomised controlled trial.
Detailed description
The objectives of this pilot trial are as follows:
- To develop a procedure for training breast cancer nurses (BCN) in the delivery of the Mini-AFTERc intervention and introduce the intervention into current NHS service provision for breast cancer patients.
- To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer patients), the fidelity of intervention elements, the acceptability to participants (primary and secondary outcomes) and detailed economic indicators for a full trial.
- Apply a formal decision making framework (ADePT) to determine a profile of factors to reveal potential difficulties and appraise solutions prior to a full trial.
This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will take place in 4 breast cancer centres in NHS Scotland health boards, including Fife, Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian) and 2 centres will deliver usual care to patients, acting as control centres (Highlands and Tayside). The project will be delivered in 3 phases:
Phase 1 will include the development and delivery of the Mini-AFTERc intervention training package for breast cancer nurses.
Phase 2 will include patient recruitment and data collection. There will be 2 intervention centres and 2 control centres across NHS Scotland. Patients who have completed their primary breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and <15 on the Fear of Cancer Recurrence 4-item Scale; FCR4). Breast cancer nurses will deliver the intervention by telephone in intervention centres, which will be audio recorded. Patients will complete a satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control group. Semi-structured interviews with 20% of patients and all nurses will be conducted to assess experiences and acceptability of the intervention.
Phase 3 will conduct data analysis and trial evaluation. Screening and follow-up data will be quantitatively analysed, including structured equation modelling. Interviews will be subject to framework analysis based on normalisation process theory (NPT). The pilot trial will be systematically evaluated using a process of decision making after pilot and feasibility trials (ADePT).
The findings will help to understand if this brief intervention can be implemented in everyday practice and can reduce FCR. They will also inform the practicality of implementation of a larger-scale randomised trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mini-AFTERcPatient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment. |
| Control group | No intervention | –Patients will receive usual care after completion of primary breast cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Mini-AFTERcStructured 30-45 minute telephone discussion based on health psychology theory and CBT principles. | Behavioural | Intervention group |
Primary outcome
Patient satisfaction with nurse communication during the Mini-AFTERc intervention
Time frame: 1 week post intervention
Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.
8 secondary outcomes
Fear of cancer recurrence level - FCR4
Time frame: 3 months
Depression and anxiety symptoms - Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Health-related quality of life - EuroQol 5 Dimension Measure of Quality of Life (EQ-5D)
Time frame: 3 months
Nurses' perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
Time frame: Within 1 month of delivering final intervention
Recruitment rate
Time frame: Duration of the pilot trial (Approx 2 years)
Retention rate
Time frame: Duration of the pilot trial (Approx 2 years)
Attrition rate
Time frame: Duration of the pilot trial (Approx 2 years)
Patient perceived acceptability of the Mini-AFTERc intervention as part of routine cancer care - Determined by theory driven semi-structured interviews
Time frame: Within 1 month of final follow-up questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Background: PubMed 29624779Davidson J, Malloch M, Humphris G. A single-session intervention (the Mini-AFTERc) for fear of cancer recurrence: A feasibility study. Psychooncology. 2018 Nov;27(11):2668-2670. doi: 10.1002/pon.4724. Epub 2018 Apr 30. No abstract available.
- Background: PubMed 29471823Humphris GM, Watson E, Sharpe M, Ozakinci G. Unidimensional scales for fears of cancer recurrence and their psychometric properties: the FCR4 and FCR7. Health Qual Life Outcomes. 2018 Feb 9;16(1):30. doi: 10.1186/s12955-018-0850-x.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 15528286Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
- Background: PubMed 28748105Cruickshank S, Steel E, Fenlon D, Armes J, Scanlon K, Banks E, Humphris G. A feasibility study of the Mini-AFTER telephone intervention for the management of fear of recurrence in breast cancer survivors: a mixed-methods study protocol. Pilot Feasibility Stud. 2017 Jul 20;4:22. doi: 10.1186/s40814-017-0161-8. eCollection 2018.
- Background: PubMed 18492319Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751.
- Background: PubMed 24160371Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.
- Background: PubMed 20961442Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
- Background: PubMed 28654189Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Mehnert A. The Hospital Anxiety and Depression Scale (HADS) and the 9-item Patient Health Questionnaire (PHQ-9) as screening instruments for depression in patients with cancer. Cancer. 2017 Nov 1;123(21):4236-4243. doi: 10.1002/cncr.30846. Epub 2017 Jun 27.
- Background: PubMed 21898134Vodermaier A, Millman RD. Accuracy of the Hospital Anxiety and Depression Scale as a screening tool in cancer patients: a systematic review and meta-analysis. Support Care Cancer. 2011 Dec;19(12):1899-908. doi: 10.1007/s00520-011-1251-4. Epub 2011 Sep 4.
- Derived from this study: PubMed 33324299Brandt NG, McHale CT, Humphris GM. Development and Testing of a Novel Measure to Assess Fidelity of Implementation: Example of the Mini-AFTERc Intervention. Front Psychol. 2020 Nov 25;11:601813. doi: 10.3389/fpsyg.2020.601813. eCollection 2020.
- FundingLink provided by the sponsor.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-AFTERc in people with Breast Cancer and Fear of Cancer, run by University of St Andrews at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerry M Humphris, PhD (+44 (0) 1334463565, gmh4@st-andrews.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with nurse communication during the Mini-AFTERc intervention (time frame: 1 week post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03763825, which also lists 13 linked publications.
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 31 May 2019.